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Page 1: NETSCC, HTA

NETSCC, HTA

14th

July 2011

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Attachment Protocol 23 June 2011 Version 2

Early parenting interventions for families with young children showing severe attachment problems: an integrated evidence synthesis

Protocol

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Attachment Protocol 23 June 2011 Version 2

Chief Investigator: Dr Barry Wright (1) Trial Co applicants: Professor Simon Gilbody (2)

Mr Stephen Palmer (3) Dr Dean McMillan (2) Ms Rachel Richardson (2) Dr Danya Glaser (4) Ms Sharon McNeil (6) Ms Vivien Prior (5) Ms Clare Whitton (6) Ms Julie Glanville 7) Mr Stephen Duffy (7) Ms Danielle Moore (1) Ms Liz Littlewood (2)

(1) Limes Trees Child, Adolescent and Family Unit, 31 Shipton Road, York, YO30 5RE (2) Department of Health Sciences, Seebohm Rowntree Building, University of York, Heslington,York, YO10 5DD. (3) Centre for Health Economics, Seebohm Rowntree Building, University of York, Heslington,York, YO10 5DD. (4) Department of Psychological Medicine, Great Ormond Street Hospital for Children NHS Trust, London England WC1N 3JH (5) UCL Institute of Child Health, 30 Guilford Street, London WC1N 1EH (6) PPI Representative, c/o Limes Trees Child, Adolescent and Family Unit, 31 Shipton Road, York, YO30 5RE (7) York Health Economics Consortium, Market Square, University of York, York YO10 5NH

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E-mail addresses: Dr Barry Wright: [email protected] Professor Simon Gilbody: [email protected] Mr Stephen Palmer [email protected]

Dr Dean McMillan: [email protected] Ms Rachel Richardson: [email protected] Dr Danya Glaser [email protected] Ms Sharon McNeil c/o [email protected] Ms Vivien Prior [email protected] Ms Clare Whitton c/o [email protected] Ms Julie Glanville: [email protected] Mr Stephen Duffy [email protected] Ms Liz Littlewood: [email protected] Ms Danielle Moore: [email protected]

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1.0 Study Identifiers 1.1 Full title of trail Early parenting interventions for families with young children showing severe attachment problems: an integrated evidence synthesis

1.2 Acronym 1.3 PROSPERO Reference 1.4 HTA Reference

10/45/04

2.0 Study Background

The importance of the relationship between mother and child has been recognised for some time (1, 2). The concept of attachment described first by Bowlby suggests that the relationship between the primary care giver (usually the mother) and other key caregivers allows the developing infant to explore the environment safely and learn how to cope with the challenges and anxieties presented by the environment (1). It also crucially allows the infant to develop templates for healthy relationships. Bowlby defined attachment as ‘the lasting psychological connectedness between human beings’ (1). One of the seminal studies into attachment behaviours was the ‘strange situation’ developed by Ainsworth and Wittig (3), which involved observing the child’s reactions in a situation where the child’s mother and a stranger interact with the infant. In sequence this involves the infant being with the mother alone, then with mother and a stranger, when left alone by them, when the stranger returns alone and then when reunited with the mother again. Mary Ainsworth proposed that an attachment ‘style’ or pattern can be observed and characterised between child and mother (4). She described three main attachment patterns within her work: secure attachment, ambivalent-insecure attachment, and avoidant-insecure attachment. A fourth pattern of attachment, coined ‘disorganized-insecure attachment’ was later added (5). A securely attached infant was thought to use the primary caregiver as a secure base for exploration, preferring to be left with the care-giver than with the stranger and protesting when separated from the primary caregiver. Infants with an avoidant insecure (anxious avoidant) attachment pattern do not use the primary caregiver as a secure base, appear unfazed by separation from the caregiver, avoiding them when reunited, and react to the stranger in a similar way to the caregiver. Ambivalent insecure (or anxious ambivalent) infants do not explore their environments and show extreme distress at separation from the caregiver. On reunion with the caregiver, the anxious ambivalent child both seeks contact with the primary caregiver, yet pulls away when contact is made. They are unable to be comforted by the stranger and resist contact with them. Finally, the more recently labelled ‘disorganised’ insecurely attached children show no consistent approach to the caregiver or

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stranger in the strange situation. They seek proximity towards others, yet this is followed by strong avoidance (6). Crittenden (7) proposed the ‘Dynamic Maturational Model.’ In this, she argued that the basis for attachment is the need for safety and ultimately to find a reproductive partner. When a child does not feel safe they may adopt organised strategies to promote protection from their relationship with the main care-giver (8). A type A strategy places greater emphasis on cognitive information, Type C strategy relies more heavily on affective information and a type B strategy uses both. A child may ‘use’ a particular strategy, but the strategy is not a part of their personality; therefore she describes children as, for example, ‘using a type A strategy’ rather than a ‘Type A child.’ Another group of attachment ‘problems’ is more clearly linked to psychopathology and these are termed ‘attachment disorders’. ICD-10 (9) defines two main attachment disorders: reactive attachment disorder and disinhibited attachment disorder. Reactive attachment disorder is ‘characterized by persistent abnormalities in the child's pattern of social relationships that are associated with emotional disturbance and are reactive to changes in environmental circumstances (e.g. fearfulness and hypervigilance, poor social interaction with peers, aggression towards self and others, misery, and growth failure in some cases)’. Disinhibited attachment disorder is described as ‘A particular pattern of abnormal social functioning that arises during the first five years of life and that tends to persist despite marked changes in environmental circumstances, e.g. diffuse, nonselectively focused attachment behaviour, attention-seeking and indiscriminately friendly behaviour, poorly modulated peer interactions; depending on circumstances there may also be associated emotional or behavioural disturbance’ (9). DSM-IV categorises four subtypes under the umbrella term of ‘Reactive Attachment Disorder’; ambivalent subtype, anxious subtype, avoidant subtype and disorganised subtype (10). This attempts to integrate the literature on attachment patterns and disorders although some have criticised this (11). More recent models of attachment have conflicted with these four main attachment types. This is partly because the attachment types resulting from the strange situation test have been less well validated in children older than 20 months (12). For example, Cassidy and Marvin (13) define five types of attachment behaviour in children aged between 2 ½ - 4 ½ years old – secure, avoidant, dependent, controlling and insecure. 2.1 Precursors Attachment is a dynamic process involving relationships and so can be heavily influenced by parental factors (e.g. mental health). Living with and managing a mental illness for a parent leads to competing needs of adult and child (14) which may impact on parent-child interactions leading to insecure attachment (15). Parental depression can lead to emotional withdrawal by a depressed parent, which can in turn lead to distorted, negative and ineffective communication between parent and child (16); this may culminate in difficulties for the child in forming and maintaining secure relationships in later life (17). There may be a cycle to the continuation of insecure attachment

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patterns, whereby attachment pattern is passed down through generations. There is some evidence for such intergenerational attachment patterns; for example VanIJzendoorn and Bakermans-Kranenburg suggested that parent attachment accounted for 22% of the variance in their children’s attachment patterns (18). Twin studies have suggested that the influence of heritability in attachment pattern is modest (19, 20) and reviews appear to agree that the influence of genetics on attachment patterns has a relatively small role to play (21). These reviews do have limitations, however, as the studies included are only based on responses in a specific situation. Rutter and colleagues state that 'it may be particularly important to focus on the biological contaminants of disinhibited attachment disorders as reflected in neural functioning (as measured by imaging approaches), and in neuroendocrine responses that may also be responsible for lasting sequelae.’ (22). However in summarising the literature Rutter (23) also makes it clear in a synthesis of earlier literature that child abuse and early institutionalisation may both make disorders of attachment more likely. 2.2 Measure of attachment There are numerous suggested ways to measure attachment. Ainsworth’s work focused on the strange situation test described above (3). Other researchers began to try to measure constructs associated with these early descriptions of attachment patterns, and the various proposed measures included observations of children, projective/story-stem scenarios, semi-structured interviews with parents, Q-sorts and parental questionnaires (24). As well as adults filling in questionnaires about their own children, it is possible to use self-report questionnaires, or semi-structured interviews, in which an adult retrospectively answers questions about their own attachment behaviours as a child (e.g the Adult Attachment Interview (25); the Family Attachment Interview (26)), in order to assess a proxy for their attachment problems as children. Self-report attachment pattern questionnaires have also been used in older children (27) using an adapted version of Hazan and Shaver (28). Accurately assessing attachment in younger children is more problematic, however. The ‘story stem’ paradigm (29) can be used to elicit attachment behaviours in this age-group. The child is given a doll family and the clinician explains the start of a story involving them, which the child then completes. The stories centre on attachment themes, such as separation (parents going away for the weekend), loss, illness and fear (child being lost in a shopping centre). Clinicians attend to the child’s representations of the adults in the story – for example whether the parents are seen as being comforting and caregiving or neglectful (30). Problems have always existed in terms of the ‘gold standard’ of measurement. There is no real gold standard against which all other measures can be validated, and the research literature is therefore peppered with instruments and tools that judge themselves against each other. Whilst

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cited as a gold standard by many, the strange situation may be used to assess attachment behaviours in infants although it does have inherent problems due to its experimental nature and therefore poor ecological validity (31), and possible bias produced by changing life circumstances and developmental trajectories for any individual child. The literature is ready therefore for a review that clarifies the current situation and gives future pointers for research. 2.3 Attachment as predictor of subsequent psychopathology Studies have shown that behaviour problems in children are predicted by attachment patterns (32-34). Speltz and colleagues (35) found that only 20% of a sample of clinic-referred children with early-onset conduct problems were securely attached to their parents, compared to 72% securely attached children in the control group. Futh and colleagues (36) examined how attachment representation related to social functioning and psychopathology in a sample of 113 children, 50% of whom were defined as high risk and 50% low risk. Behaviour problems rated by teachers were linked to disorganised attachment patterns. Disorganised attachment representation was also predictive of poorer social functioning. There is also some evidence that insecure-disorganised attachment difficulties may also result in poor school attendance, conduct disorder and academic underachievement (37). Adults rated as displaying an insecure attachment style are more likely to experience psychiatric illness than those with a secure style (18). Indeed one study found that whilst a normative population had 50% secure attachments, there were only 16% secure attachments in a population with psychiatric disorders (38). Retrospective work has shown that adults with depression are more likely to describe their parents as rejecting and/or unsupportive (39). Offenders are also more likely to report disturbed or insecure attachments, and separation from attachment figures in childhood has been found to relate to personality disorder in offenders (40). Infants with disorganised attachments are more likely to suffer adolescent anxiety disorders than those with secure attachments (41). Insecure attachment is also linked to increased reactivity to stress (42), notably in increased cortisol reactivity, which has itself been associated with a range of psychopathologies, notably psychotic illness (43). However, the literature is littered with ambiguities. Although insecure attachment patterns may represent risk factors for future problems, approximately one third of infants show some form of insecure attachment in normal populations. Thus, the organised insecure patterns of attachment should not be considered as indicators of pathology, but rather, may be considered as risk factors for associated difficulties in the child’s functioning (22). In this sense, whilst many people with psychopathology may be more likely to have had attachment problems, most infants with attachment pattern difficulties do not go on to develop psychopathology. Indeed, measurements from the strange situation are poor predictors of psychopathology in longitudinal studies (44).

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Some severe forms of attachment problems, such as disorganised attachment, are however associated with a range of difficulty in later childhood and adolescence. Longitudinal studies have linked disorganised attachment with hostility and hyperactivity, aggression and oppositional defiant disorder in children (45) and dissociative symptoms in 17 and 19 year olds (46). Furthermore, attachment disorders, as distinct from insecure attachment patterns, are known to have increased comorbidity with conduct disorders, developmental delay, attention deficit hyperactivity disorder and post-traumatic stress disorder (12). In summary, while there is some evidence that more severe forms of attachment problems are related to psychopathology, the link between less severe forms and subsequent problems is not so clear (22). Again, this lends itself urgently for review given that many clinicians use the paradigm of attachment in assessment and intervention, and we need to better understand the evidence that informs this clinical practice. 2.4 Interventions for attachment problems Juffer and colleagues (47) undertook a meta-analysis of interventions aimed at increasing sensitivity, improving attachment, or both. 70 studies, including 88 interventions, were including within the analysis. The authors report that ‘some samples were middle-class families with typically developing infants.’ The most effective interventions were found to be those with a focused, behavioural approach, which were aimed at increasing parental sensitivity. They were particularly effective when video-feedback was used. 29 of the interventions investigated were specifically intended to improve attachment security. These showed a significant, though small effect size (d = 0.19). Again, those interventions which targeted parental sensitivity were the most effective at improving attachment relationships. Although this meta-analysis resulted in the development of a promising intervention (47), the interventions included focused much more widely than children with severe attachment problems, including preventative interventions for children with no current attachment problems. Similarly, a review by Dretzke and colleagues (48) looking at parent training/education programmes in conduct disorder have not looked specifically at attachment. Based partly on the findings of this review, guidelines were published in 2006 by the National Institute for Heath and Clinical Excellence (NICE) and the Social Care Institute for Excellence (SCIE) which recommended group-based parent-training/education programmes in the management of children 12 years and younger (or with a developmental age of 12 years or younger) with conduct disorder (or oppositional defiant disorder). Given what we know about co-morbidity many of these children will have had attachment disorders. Single family therapies were recommended for those parents who are difficult to engage or where the family’s needs were more complex. It was recommended that such parent-training/education programmes should incorporate a number of essential elements, to include: a structured programme grounded on principles of social learning theory; an optimum number of sessions and relationship enhancing strategies. Programmes are typically behavioural-focused (e.g. teaching parenting skills)

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or relationship-focused (e.g. helping parents to understand their own and their child’s emotions and behaviour) and are intended to improve the parents’ relationship with their child, improve the child’s behaviour, and to improve communication with their child. Group-based programmes were found to be the most cost-effective with most cost savings in the areas of education and health services. Although parent child relationships are at the heart of these interventions, the extent to which children in these groups had attachment co-morbidities was not specified and so interventions suggested, whilst potentially promising for those with attachment disorders, have not been systematically reviewed. 2.5 Policy and practice The introduction of the ‘Every Child Matters’ agenda (49) and the Children’s Act (2004) (50) provided a framework for services at all levels of provision to work together holistically to support children’s development. The Government has recognised that the early years of a child’s development are of vital importance (51). This has been realised by the Children’s Plan (52), a 10 year strategy which aims to promote the development of social and emotional skills during the early years of a child’s life and onwards, including the promotion of attachment and bonding in the first years of life. The Early Years Foundation Stage (53) was developed with a focus on learning, development and welfare standards, and looks at the whole range of a child’s cognitive and non-cognitive development. The Department of Children, Schools and Families also intends to deliver The Social and Emotional Aspects of Learning (SEAL) Programme in schools by 2011 which will facilitate such skills. An Early Years Commission report ‘Breakthrough Britain: The Next Generation’ published by The Centre for Social Justice (54) has criticised current Government policy for failing to include the importance of relationships in young children’s development, stating that there is ‘no recognition of the fundamental role that attachment and familial relationships play in bringing about children’s well-being’, instead focusing on reducing economic poverty and improving educational achievement. The report argues that children who experience ‘relationship dysfunction’ are at a higher risk of later life difficulties than children exposed to economic or educational disadvantage. The Early Years Commission report highlights the importance of parent-child relationships during the earliest years of a child’s life and the need for effective intervention strategies aimed at parents in order to enhance children’s social and emotional health and well-being. The report acknowledges how emotional, environmental, physical, biological and social factors are all interrelated. The report further concludes that parenting educational programmes are effective and recommends the use of Parent Management Training, an umbrella term for a group of parenting interventions. Such programmes include the Incredible Years Programme, Triple P and Parent-Child Interaction Therapy. Other attachment based therapies such as Theraplay also fall into this category. The Department of Health has now developed the Child Health Promotion Programme: Pregnancy and the first five years of life, an early intervention

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and prevention public health strategy for children 0-5 years (55). The CHPP feeds directly into The Children’s Plan (52) and contributes to the National Service Framework for Children, Young People and Maternity Services (56). The CHPP aims to improve health and well-being of children by adopting an integrated approach to support for children and families. This is delivered by health professionals, particularly health visitors, and is a service provided within Sure Start Children’s Centres (57). The Department of Health advocate that effective implementation of the CHPP should lead to ‘strong parent-child attachment and positive parenting, resulting in better social and emotional wellbeing among children’. A further core element of the CHPP is the identification of risk factors that make some children at a greater risk of experiencing poorer outcomes in later childhood than other children. The CHPP also delivers evidence-based preventive interventions for effective parenting. One such programme is the Family Nurse Partnership programme (58), a home-based preventive programme aimed at high-risk young first-time parents delivered by nurses. The National Academy of Parenting Practitioners (NAPP) was established in 2007 with the aim of training and supporting practitioners in evidence-based parenting skills, programmes and therapies. Building on the knowledge gained by CHPP in ‘what works’, a key aim of NAPP is to evaluate high quality evidence in order that commissioners can commission effective parenting programmes. A Commissioning Toolkit containing a database of parenting interventions, available for different situations, has since been developed by the Children’s Workforce Development Council in 2008 (http://www.commissioningtoolkit.org/). The Department for Education and Skills set up The Parenting Fund in 2004 which funds projects to provide direct support to parenting services and to support nurturing relationships. 2.6 Purpose of the present review The purpose of the programme of work proposed in this bid is to apply rigorous systematic review and evidence synthesis methods to evaluate the clinical and cost effectiveness of parental intervention programmes where children have severe attachment disorders. In the absence of direct evidence of effectiveness and cost effectiveness we will use advanced decision modelling techniques to investigate these issues. We anticipate that in the absence of fully randomised evidence, further research recommendations will be made as a conclusion to this review. Such recommendations will be prioritised and the potential yield of such research (to resolve clinical and economic uncertainty) will be explicitly studied using a ‘Value of Information analysis’. We will build on and expand the review the 2003 Bakermans-Kranenburg et al (2003). Firstly, the review will be updated. Given that our study will be starting in 2011, we will be able to include an additional 10 years of literature. Secondly, our review will examine cost-effectiveness as well as efficacy. Thirdly, the Bakermans-Kranenburg et al (2003) review focused around sensitivity and attachment interventions; our review will take a much broader focus looking at any interventions that improve quality of life or psychological well-being.

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As highlighted above in the brief literature review there are several gaps and ambiguities in the literature, not least the need to investigate the effectiveness of interventions in the UK setting (59) and this confirms that ‘the area of attachment is ripe for greater synthesis of evidence based practice that covers both intervention and assessment’(24). 2.7 Research Objectives What are the most clinically and cost effective interventions to improve quality of life and psychological wellbeing for children with severe attachment disorders? 2.8 Research Aims 1. To review the methods of assessment and/or diagnosis of attachment problems and/or disorders. 2. To examine the prevalence, natural history and longer term risks of developmental, psychological and behavioural disorders amongst children with severe attachment disorders. 3. To identify the range of intervention programmes that are designed for parents of children with severe attachment disorders. 4. To examine the clinical effectiveness of intervention programmes designed for parents of children with severe attachment disorders (with and without comorbidities such as conduct disorder). 5. To examine the cost effectiveness of intervention programmes designed for parents of children with severe attachment disorders. 6. To identify research priorities for developing future intervention programmes for children with severe attachment disorders, from the perspective of the UK NHS.

3.0 Study Design Whilst the call for this review uses a terminology that focuses around severe attachment problems, for the purposes of understanding this in the context of the current research literature, we have separated this into two main areas of research, namely i) insecure attachment patterns, including insecure-disorganised and ii) attachment disorders. Phases 1 and 2 of the study will include both of these areas. For the remaining phases we will consider all attachment disorders and any insecure attachment patterns that have been shown to have an association with child mental health disorders. The question that the brief asks us to consider is not entirely clear. The title of the brief is ‘Early parenting intervention for families with young children showing severe attachment problems’, which suggests that the focus should be on children who are already showing severe attachment difficulties. The mention of diagnosis in the design section also suggests that application should focus on interventions for children who already have some form of severe attachment problem. However, the research question is ‘What is the effectiveness and cost-effectiveness of an early parenting intervention for parents whose children show signs of developing severe attachment problems?’ and at one other point the brief refers to prevention. This would suggest a broader review that would include preventative interventions as well

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as interventions for those children already displaying severe attachment problems. We have made an initial decision to include preventative interventions as well as those for children showing severe attachment problems. If, however, the HTA board feels a different emphasis is called for, we would be happy to alter our review accordingly. The programme of research will progress in six interlinked phases where we will summarise the available research literature regarding intervention programmes for parents of children with severe attachment problems (or who are at high risk of developing such problems). We have defined attachment problems in an inclusive way in order to capture all the important literature in this area. Attachment problems will include attachment patterns (e.g. insecure, disorganised etc.) and attachment disorders (disinhibited attachment disorder and reactive attachment disorder). Whilst we recognise that attachment problems and conduct disorders are different disorders and have different diagnostic criteria, we also recognise that there is a high rate of comorbidity between the two (34, 35). Attachment problems are thought to be a risk factor for the development of conduct disorders; therefore, where we make reference to interventions for severe attachment problems, we also intend to include any literature where conduct disorders or other mental health problems are co-morbid with attachment problems. We will explicitly examine the robustness of any findings to the presence or absence of comorbidity in sensitivity analyses. We will synthesise a range of study designs (e.g. quantitative, qualitative, descriptive, economic) incorporating i) types of interventions as specified in NICE guidelines (e.g. group-based parent-training/education programmes, individual-based programmes); ii) attachment problems (e.g. attachment patterns, reactive attachment disorder and disinhibited attachment disorder); iii) age groups of children; and; iv) origins of attachment problems relevant to each of the specific aims outlined above. Each phase has a specific aim necessitating different study selection criteria.. At all stages we will adhere to accepted guidelines laid down by CRD report number 4 for the conduct of systematic reviews (60). We seek to contextualise our review in terms of UK practice and the cost effectiveness analysis will take into consideration financial models around provision of services within the UK. In addition, the team have incorporated strong PPI and content expertise throughout the bid and will identify and engage high influence stakeholders, such as service commissioners and policy makers. PPI is an important part of our bid and we will make use of users, carers and parents from intervention groups in an iterative fashion to ensure that our bid remains relevant to UK practice. We will not however exclude interventions developed in other parts of the world where they may be applicable in a UK context and the PPI group will be an important mechanism for ensuring appropriate inclusivity. 3.1 Phase 1: To review the methods of assessment and/or diagnosis of attachment problems and/or disorders. As highlighted in the introduction, a variety of different methods have been used to assess attachment in childhood. Some methods are used to assess attachment patterns whilst others are used to diagnose attachment disorders.

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The relationship between attachment patterns and attachment disorders is unclear. In this phase we will fully investigate the variety of assessment/diagnosis methods used for assessment of attachment patterns and attachment disorders. Although this is not stipulated in the brief, we believe this to be a necessary preliminary stage to producing an authoritative overview of the topic. This will add to the academic content of the review and will be an important addition to the literature in this area. This review will add value to the programme of research as a whole. 3.1.1 Search strategy Data sources. Studies will be identified by searching major databases including MEDLINE, EMBASE, ERIC (Educational Resources Information Center), PsycINFO, Science Citation Index (SCI), Social Science Citation Index (SSCI), Research Register for Social Care, Social Care Online (SCO), Social Services Abstracts, Sociological Abstracts, ASSIA (Applied Social Science Index and Abstracts), The British Education Index (BEI), the Cochrane Library, NHS Economic Evaluation Database (NHS EED) and Health Economic Evaluations Database (HEED). Studies in progress, unpublished research or additional sources of grey literature will be identified from the following databases: OAISTER, Index of Theses, ZETOC, ISI Proceedings Science & Technology, ClinicalTrials.gov, Current Controlled Trials, ClinicalStudyResults.org, Clinical Trial Results, World Health Organization International Clinical Trials Registry Platform (ICTRP), UK Clinical Research Network Study Portfolio and HSRProj. All resources will be searched from their inception to the most recent date available. Internet searches will be carried out using the specialist search gateways Intute (www.intute.ac.uk) and MedlinePlus (http://www.nlm.nih.gov/medlineplus/) to identify relevant resources. Potentially relevant websites identified during the initial internet gateway searches will then be searched and browsed. Examples of organisation websites to be searched include the following: American Psychiatric Association (http://www.psych.org/), Mental Health Foundation (http://www.mentalhealth.org.uk/), MIND (http://www.mind.org.uk/), Royal College of Psychiatrists (http://www.rcpsych.ac.uk/), National Collaborating Centre for Mental Health (NCCMH) (http://www.nccmh.org.uk/), National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/index.shtml). The bibliographies of relevant reviews and guidelines and all included studies will be checked for further potentially relevant studies. We will also conduct reverse citation searches of key references. In addition, we will contact experts in the field, including members of the stakeholders groups, to identify additional relevant sources of material. Search terms. Search terms will cover a variety of attachment terms and diagnosis and assessment terms (e.g. attachment*, attachment pattern*, attachment pattern*, attachment disorder*). These will be developed further in steering group meetings in collaboration with co-applicants Glanville and

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Duffy, who have specific expertise in the development of search terms for complex reviews. 3.1.2 Inclusion-Exclusion criteria for Phase 1 Study design: cross sectional studies, case control studies or prospective cohort studies incorporating any method of assessment (for example observation, semi-structured interviews and questionnaires). Population & exposure: Young children aged under 12 (the age range in which NICE guidelines specify parenting interventions for children with attachment problems). The research brief does not stipulate the exact definition of ‘severe attachment problems’. At this point, we would wish to be inclusive and will include all papers that include any attachment disorder diagnoses or insecure attachment patterns. Outcomes: diagnoses of unhealthy attachment patterns, attachment disorders, unhealthy comorbid attachment patterns/diagnoses with conduct disorder/oppositional defiant disorder. 3.1.3 Data extraction All data will be extracted independently by two independent reviewers. We will extract data on the details of the assessment method and any information on the reliability and validity of the method used. Applicants Gilbody and McMillan have specific expertise in evaluating the psychometric properties of assessment tools and we will make use of this in critiquing these measures. 3.1.3 Data synthesis On the basis of the above exercise, we will also produce a taxonomy within which to classify the range and diversity of assessment/diagnosis methods. We will also produce a narrative synthesis summarising the psychometric properties of those instruments. 3.1.5 Outputs of Phase 1:

1. Phase 1 will meet objective 1. 2. This will be an important contribution to the child and adolescent

literature and will be useful in informing service provision of the variety of methods and the psychometric properties of instruments that may be used to assess/diagnose unhealthy attachment patterns and disorders.

3.2 Phase 2: To examine the prevalence and natural history of attachment problems and longer term risks of developmental, psychological and behavioural disorders amongst children where there are severe attachment problems. As stated in the introduction, there is a relative paucity of systematic reviews examining prevalence data for childhood attachment problems and/or disorders. This phase of our review will apply rigorous systematic review methods to determine prevalence, natural history and longer term risk in association with childhood attachment problems. Previous systematic reviews have included interventions aimed at preventing attachment problems as well as intervening in attachment problems and do not explicitly focus on

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the UK population (59). We will apply recent guidance on the synthesis of survey data (judging prevalence) and longitudinal data (judging longer term outcome) (60). We are aware that this is a large topic. We will constrain this phase of the review by focusing on high quality studies. 3.2.1 Search strategy Relevant studies will be identified from the searches conducted for phase 1. 3.2.2 Inclusion-Exclusion criteria for Phase 2 Study design: Studies with a robust epidemiological design (case control, cohort studies) where prevalence is measured at inception. We will only use studies where attachment problems have been measured using valid and reliable methods (as found in phase 1). Population & exposure: Young children aged under 12 (the age range in which NICE guidelines specify parenting interventions for children with conduct disorder (often co morbid with attachment disorder). The research brief does not stipulate the exact definition of ‘severe attachment disorder’. As in the previous phase, our intention here is to be inclusive: we will include all papers that include any attachment disorder diagnoses or insecure attachment patterns. Outcomes: population incidence of attachment problems; natural history; rates of subsequent mental ill health; psycho-social development; educational attainment; entry into care and the criminal justice system. We will only examine validated outcome measures in each of these domains. Comparator: We will select studies with a comparator or control group to judge the strength of the association between exposure and outcome for all above outcomes, with the exception of prevalence data. If after an initial scoping of the literature, we feel there is a need to further constrain this phase of the review, we will restrict our examination of longer-term outcomes to prospective cohort studies. 3.2.3 Data extraction and synthesis All data will be extracted independently by two independent reviewers. We will provide a narrative synthesis of data. on each of the outcomes, and where appropriate use existing meta-analytic procedures to provide pooled estimates and explore heterogeneity of prevalence data and rates of negative outcomes. 3.2.4 Outputs of phase 2:

1 Phase 2 will meet objective 2. 3. This will be an important contribution to the child and adolescent

literature and will be useful in informing service provision and assessment of need. We will seek specific risk factors (such as age, attachment patterns, and origins of attachment problems) and protective factors (such as resilience and social support).

4. Information will have been obtained regarding which attachment patterns are linked to psychiatric disorders or other adverse outcomes, in order to inform phase 3 of the study.

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5. Robust epidemiologically-derived estimates of prevalence, natural history and longer term risk will inform our decision model (see phase 5).

3.3 Phase 3: Identification of the range of intervention programmes that are designed for parents of children with severe attachment problems. In our introduction, the selective overview of the range of interventions for parents of children with severe attachment problems has highlighted some of those interventions of which we have knowledge. A preliminary step in conducting an overview in this area is to add to this literature by identifying the range of possible interventions that have been designed for or applied in this population. In this phase, we will define severe attachment problems as attachment disorders and those attachment patterns associated with adverse outcomes, including mental health problems, as explained previously. We will examine interventions for children already showing these problems, but will also consider intervention aimed at preventing the development of severe attachment problems. 3.3.1 Search strategy We will conduct a ‘scoping review’ to describe all potential interventions (irrespective of the evidential support that has been used to underpin them). We will pay particular attention to the type of attachment disorder or attachment pattern for which an intervention has been used and the degree to which parenting interventions are potentially generaliseable across attachment disorders/patterns, populations, age ranges and cultures. In order to produce a comprehensive list of intervention programmes, we will first:

Conduct a scoping literature review Check key texts and policy documents for intervention programmes and

references Utilise the expertise within the research group (see expertise section for

our expert reference group). The research group includes professionals directly involved as well as patient and public involvement in the form of a user/carer parenting group, who will be aware of current trends in parenting intervention programmes and who will aid us in the search for interventions.

The scoping review will be undertaken in the first instance to identify as many potential intervention programmes as possible. The scoping review will include databases and resources as specified in the search strategy detailed in phase 1. We will ask service users to identify any interventions with which they are familiar. Once potential intervention programmes have been identified we will develop a search strategy using a combination of two concepts to capture the patient group/disease (children with ‘severe attachment problems’ – as defined in phase 2 of the review) and the interventions of interest, according to the guidelines for exhaustive searching prepared by the CRD and the Cochrane Collaboration (60, 61).

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3.3.2 Inclusion criteria for scoping review - Phase 3 Study design: Case studies, descriptive or interventional studies of any type. There will be no restriction by country of origin, language or publication date. Population: Parents of young children (under 12 years) who have severe attachment problems (either attachment disorders or attachment patterns) or who are at high risk of developing such problems. Intervention: any psychological, social, educational, environmental or organisational intervention targeted specifically at the parents of children who have severe attachment problems or are at high risk of developing such problems. Interventions that intervene with both the parent and child, but which are based on primarily a parenting intervention will be included. On the basis of the above exercise, we will also produce a taxonomy within which to classify the range and diversity of interventions. 3.3.4 Outputs of phase 3:

1. Phase 3 will meet objective 3. 2. This will generate a taxonomy and comprehensive overview of the

range of interventions that are possible in this area. 3. Our overview will inform the review of effectiveness and cost

effectiveness and will help highlight those areas which are under-researched and underdeveloped.

4. All potential intervention programmes will then be subjected to a systematic review of validity, utility and acceptability outlined below.

3.4 Phase 4: To examine the clinical effectiveness of intervention programmes designed for parents of children with severe attachment disorders (with and without comorbidities such as conduct disorder). Having identified the range and diversity of approaches that are possible in this area, we will then subject them to a rigorous review of evidence to assess their effectiveness. We will conduct a systematic review of randomised evidence in line with guidance issued by the Cochrane CRD report 4 (60) and the Cochrane Collaboration (61). Our evidence synthesis will be both a narrative and quantitative overview of this body of research with due reference to the methodological strengths and weaknesses. As in the previous phase, we will examine interventions for children already showing severe attachment problems, but will also consider intervention aimed at preventing the development of such problems. 3.4.1 Search strategy Relevant studies will be identified from the searches conducted for phase 1. 3.4.2 Inclusion-Exclusion criteria – Phase 4 Study Design: randomised controlled trials Population: Parents of young children (under 12 years) who have severe attachment problems (as defined by Phase 2) or are at high risk of developing such problems Intervention: all interventions identified in phase 3 Outcomes: Rates of attachment problems, quality of life; psychological wellbeing; rates of mental ill health at any age; psycho-social development;

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educational attainment; entry into care and the criminal justice system; acceptability of the intervention to parents. We will prioritise validated outcome measures in each of these domains. Comparators: no intervention, an attention control or other ‘psychological placebo’, or usual care. 3.4.3 Data extraction Data will be extracted independently by two reviewers and we will judge methodological quality and sources of bias using the Cochrane assessment of bias tool (61). 3.4.4 Data synthesis We will facilitate cross comparison of effectiveness by using standardised measures of effect (Cohen’s D) and by classifying short (< 6 months), medium (6-18 months) and longer term (>18 months) follow up and outcomes. Where studies are sufficiently similar in terms of interventions and populations, we will (with caution) undertake a meta-analysis using accepted methods, including:

1. Random effects meta-analysis and measurement of between-study heterogeneity using Higgins’ I2 statistic (62).

2. Exploration of potential sources of heterogeneity using pre-specified predictors (age, diagnosis and duration of follow up).

3. Meta-regression where there are sufficient data-points and predictive covariates (in line with guidance offered by Higgins and colleagues (63).

3.4.5 Output of Phase 4:

1. Phase 4 will meet objective 4. 2. We will ensure the results of this review are published as early as

possible as a stand-alone publication, and (by following Cochrane guidelines and by registering our review with the Cochrane collaboration) we will ensure that the review is published as a protocol and full review in the Cochrane Library. Prof Gilbody is a Cochrane Group Editor.

3. Our estimates of effectiveness (and ranges of synthesised uncertainty) will be used to populate our decision model in phase 5.

3.5 Phase 5: To examine the cost effectiveness of intervention programmes designed for parents of children with severe attachment problems? 3.5.1 Methods of Review: Within constrained mental health and social services, the issue of cost effectiveness is paramount in informing service provision and innovation (including new investments or prioritisation of new services). Enhanced intervention strategies for parents of children with severe attachment problems (or who are at high risk of developing such problems) will have cost implications for the NHS. However, the benefits in terms of reduced psycho-social morbidity, and therefore reduced treatment costs, may outweigh the

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initial cost of implementing such interventions. The research brief explicitly asks that cost-effectiveness be addressed within this review. We will examine the cost effectiveness of intervention programmes for parents of children with severe attachment problems in two ways. First, we will search for and systematically review any available economic evaluations of intervention programmes. Secondly, we will develop a decision analytic model to examine the cost effectiveness of intervention programmes for parents of children with severe attachment problems from the perspective of the UK NHS. Decision analysis has already been used by the current team to examine the cost effectiveness of screening programmes for Post Natal Depression (64, 65) and we intend to adopt a similar approach. 3.5.2 Systematic review of economic evaluations of intervention programmes for parents of children with severe attachment problems We will review all available full economic evaluations (cost benefit analyses, cost effectiveness analyses, and cost-utility analyses) of each of the interventions highlighted in phase 2. We will follow explicit guidelines laid down by CRD in the preparation of the NHS Economic Evaluations Database (NHS EED) (66). In particular, we will judge the quality and relevance of available economic data, from the perspective of the UK NHS according to criteria laid down by Drummond and colleagues (67). Searches for economic evaluations and other data to populate the model will be undertaken in the databases listed in phase 3, and in other appropriate resources. Further searches of NHS EED and Health Economic Evaluations Database (HEED) will also be carried out along with searches of Economics Working Papers archives such as the Economics Working Paper Archive. The search strategy described above will be adapted to focus on economic evaluations using terms taken from the strategies used to identify studies for inclusion in NHS EED (66). A broad range of studies will be considered in the assessment of cost-effectiveness including economic evaluations conducted alongside trials, modelling studies and analyses of administrative databases. Only full economic evaluations that compare two or more options and consider both costs and consequences (including cost-effectiveness, cost-utility and cost-benefit analyses) will be included in the review of economic literature. Secondly, we will construct a de-novo decision analytic model to examine the cost effectiveness of intervention programmes from the perspective of the UK NHS. The review of economic studies will outline the limits of existing evidence in this area. 3.5.3 Decision model of intervention programmes for parents of children with severe attachment disorders The decision model will provide a quantitative framework to synthesise the best available evidence on the clinical effectiveness and costs of the alternative interventions and to link this to longer term consequences which have additional cost and outcome implications. The model will also provide an indication of where existing evidence is most uncertain and where future

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research could be most valuable in addressing the needs of both service commissioners and research funding agencies. The use of decision analytic and value of information approaches are central to informing these needs in an explicit and transparent manner and is evident in the central role they play at a national level in informing decisions made by NICE. We therefore envisage that the findings would be directly relevant to service commissioners at both a national and local level as well as providing an indication to the research community and funders where additional evidence would appear to provide most value. The systematic reviews outlined above will provide estimates of the effectiveness of intervention programmes for parents of children with severe attachment disorders based on the best available research evidence. On the basis of our foreknowledge of the literature, we expect that there will be limited cost-effectiveness information available specific to a UK context. The information identified from the above sources will be necessary but not sufficient for decision-making about intervention programmes in the UK NHS. Modelling has the capacity to overcome anticipated limitations in the evidence base identified in phases 1-4. For example modelling can consider a plausible range of effectiveness estimates and long-term consequences of intervention programmes (68). The results of the reviews 1-4 will provide important inputs in terms of magnitude and plausible ranges of effect sizes. However, they will be necessarily limited in terms of the amount and scope of data available to consider the wide range of issues relating to health care costs and consequences of relevance to the UK NHS. Decision modelling will be used to bring together various sources of evidence within an explicit quantitative framework for potentially valid and effective intervention strategies outlined in phases 1-4. Decision modelling will follow best practice guidelines in framing the decision, relating this to routine UK clinical practice, populating the model with best estimates from a range of data sources (randomised and observational designs), and in exploring the robustness of results and uncertainty of decisions (69). We acknowledge from the outset that this will be a complex area in which to construct a model, since there may be few longer-term epidemiological studies, and the costs and benefits associated with intervention programmes might be realised in social/welfare domains, and over the longer term. The main estimates of the clinical effectiveness of interventions will be those which are identified in the traditional systematic review of trial-based evidence (phase 4). Aspects of service use and longer term prognosis (including conduct disorder) will be derived from the research literature and expert consensus. The impact of these interventions may potentially be seen across a number of sectors. From a cost perspective alone there could be impacts in terms of health, education, social care, criminal justice and the third sector. The main perspective for our model will be consistent with that recommended by NICE (NHS/PSS). However, we will make some exploratory analyses in other sectors, to help judge the return of NHS investments in terms of other sectors. We will not therefore be constrained to only reporting a cost per QALY

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analysis. A range of approaches may be required including descriptive cost consequence analyses, cost effectiveness analysis and cost utility analysis. We will judge the effectiveness of interventions according to the outcomes that are reported in individual studies. We would ultimately try to conduct a cost utility analysis to estimate the incremental cost per QALY of the alternative interventions. This will provide consistency with the preferred approach to measuring outcomes for cost-effectiveness studies stated by NICE. Where utilities are not reported in trials, we will estimate health state utilities with reference to the non-trial based research literature or from expert consensus. We recognise the potential challenges of using a QALY approach in this population and will also present separate analyses using a cost-consequence approach i.e. presenting disaggregated cost and non-QALY outcome data. We will construct two models. The first (short-run) sub-model will consider the acquisition and staff costs of the intervention strategies and any associated health service costs related to their implementation. The second (long-run) element of the model will seek to estimate the health effects of these possible outcomes and the clinical benefits of early intervention for childhood problems. In constructing our model, we will consider involving clinical and social care expertise in helping to structure the initial decision model (i.e. make it less defined by the availability of the data but by the nature of the problem). This will help to map out the relevant care pathways across different sectors and consider where in these pathways particular services might impact. We will use problem solving methods which are starting to be used in the development of decision models which provide a more formal approach (for example, consensus development and elicitation techniques) when using expert input to help define the relevant questions, care pathways and cost domains. A key function of our decision analysis will be to explicitly assess the extent of uncertainty. The extent and quality of the evidence will be reflected in probability distributions based upon the results of our meta-analyses in earlier phases and other inputs used to populate the model. Our probabilistic model will be constructed and analysed using computerised Monte Carlo simulation methods using excel models The uncertainty surrounding estimates of cost effectiveness for a range of thresholds will be represented using cost effectiveness acceptability curves (CEACs) (70). 3.5.4 Outputs of phase 5: The outputs of this phase will be an explicit probabilistic summary of best estimates of cost effectiveness for intervention programmes for parents of children with severe attachment disorders, based on best available information. These will be useful in deciding which, if any, of these interventions are likely to be clinically useful and cost effective within routine NHS practice. Phase 5 will address aim 5 of our research programme. On the basis of the results of phase 5, decision makers will be able to plan

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intervention programmes for parents of children with severe attachment disorders, such that they are maximally effective and efficient on the basis of existing research. 3.6 Phase 6: What are the research priorities for the NHS in developing future intervention programmes for parents of children with severe attachment problems We will evaluate future research priorities (to include promising interventions which have not been conducted within the UK, or which have not been investigated in a large scale randomised controlled trial) using the information gathered from phases 3-5. 3.6.1 Expected value of information (VoI) analysis It is clear from the HTA brief that a need for further primary research is being considered – particularly the need to develop and evaluate new interventions in this population. Within phase 6 we will identify and prioritise this research and examine whether the HTA programme can expect any tangible benefits to emerge from further research that they might fund in this area. Where possible, the most appropriate method to address this question is value of information analysis (71, 72). Our first step in prioritising research will be, on the basis of our decision model, to map out the structure of the decision model and to highlight where there are major data gaps. We anticipate our model will not provide the definitive answer in relation to the cost effectiveness of interventions for severe attachment disorders, given the limitations of the primary research literature. We will identify the main sources of uncertainty that exist in this area, and the degree to which estimates of cost effectiveness are dependent upon these uncertainties. The value of information (VoI) analysis is the logical next step from our decision model, whist being cognisant of the fact that a VoI analysis will be constrained by very limited parameter inputs in this case.. It uses a rational approach in discerning which research priorities will be worth pursuing, by using a quantitative approach that assesses the consequences of uncertainties. It is used as a benchmark to establish the potential value for money of additional future research. This is especially useful to funders who might want to commission further (primary) research on the basis of an integrated evidence synthesis in order to reduce ‘decision uncertainty’. Our VoI will help to inform (for example) whether it would be sensible and good value for money to commission a trial of interventions for conduct disorder. Our VoI will be of particular relevance to the UK NHS in this respect. 3.6.2 Rationale for value of information analysis: Decisions about whether to adopt a specific intervention programme for parent of children with severe attachment problems based upon existing information will be uncertain, and there will always be a chance that the wrong decision will be made regarding adoption in the NHS. If the wrong decision is made, there will be a cost in terms of the health benefit and resources forgone. In this case parents of children with severe attachment disorders

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might receive an intervention that is ineffective or inefficient. Given the prevalence of attachment disorders and the major adverse consequence of having a severe attachment problem, the consequences of a wrong decision are likely to be substantial. Better quality information produced by further research can help reduce this uncertainty and reduce the chance of a wrong decision being made. Further research, under this analytic perspective, has a value and a benefit to society which can be quantified. The expected costs of uncertainty can be interpreted as the Expected Value of Perfect Information (EVPI) since perfect information will eliminate the possibility of making the wrong decision. In the UK, this EVPI can be expressed for the total population of parents of and children with severe attachment problems who stand to gain from improved recognition and management. If the value of this information exceeds the costs of conducting further research, then it very quickly becomes apparent that this research is cost effective and a sensible use of finite research resources (71, 72). The value of reducing uncertainty surrounding particular input parameters in the decision model from phase 4 can also be established (partial EVPI). This type of analysis can be used to direct further research by focussing on those inputs for which more precise estimates would be most valuable. The research brief indicates that further research into intervention programmes for parents of children with a severe attachment problem might be seen as a priority. However, this might not be the most efficient use of finite NHS research funds. The EVPI will be used to provide an upper bound on the value of additional research to that provided by the decision model constructed in phase 4. This evaluation can be then be used as a necessary hurdle for determining the potential efficiency of further primary research. According to such a decision rule, additional research should only be considered if the EVPI exceeds the expected cost of the research. The partial EVPI of individual or groups of parameters will be estimated using Monte Carlo simulation assuming no uncertainty surrounding the parameter(s) of interest. The EVPI for the parameter(s) of interest is then determined by the difference between the EVPI for the full model and the EVPI for the model excluding the relevant parameter(s). This level of analysis has been tried and tested in other conditions by the applicant Palmer including a recently published model and EVPI for post natal depression (HTA project).

3.6.3 Outputs of phase 6

1. Phase 6 will meet aim 6. 2. We will explicitly prioritise areas of further research in this area which

will be informative to research bodies funded from the public purse in that the research addresses the greatest areas of uncertainty and addresses areas of clinical need.

4.0 Ethical Arrangements As is standard practice for systematic reviews, we do not expect that we will need to seek ethical approval. Although ethical approval is typically not necessary, ethical issues can arise when the review involves contacting authors of original studies to request patient-level data. From our

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foreknowledge of the available literature we do not expect that we will need these types of data.

5.0 Patient and public involvement (PPI) As part of the development of this detailed project description we have discussed the review and specific questions with a number of stakeholders, including professionals at Lime Trees Child, Adolescent and Family Unit and user/carers from a parenting intervention group. Co-applicant McNeill is a member of this group and has advised on the proposal. The stakeholders were asked to comment on various aspect of the proposed design of the review, such as what constitutes severe attachment problems, the use of specific assessment methods and existing parenting interventions. We will extend this initial stakeholder group to involve additional carers and professionals to ensure suitable representation. We have had discussions with the initial stakeholder group about who else we should approach to be involved. Our intention here is that applicant McNeill will feedback information regarding the research to other members of the parenting intervention group she attends as well as helping us to identify other similar parenting intervention groups. We will also, through discussion with content experts, identify and engage high influence stakeholders, such as policy makers and service commissioners. From these sources we will develop stakeholder involvement groups, and will hold stakeholder workshops, which will provide guidance on four areas: 1) clarifying objectives and the design of our review, 2) structuring and populating the decision model, 3) interpreting the results of our review, and 4) developing and implementing a dissemination strategy. Service users will therefore assist in informing the decision model including design, implementation and dissemination. The stakeholder group will be asked to comment on currently used terminologies around severe attachment problems and will be asked to suggest search terms for the systematic review. The stakeholder group will be involved in reviewing the findings for real life application. This will include their views about the acceptability and feasibility of interventions suggested from a user/carer perspective. This will help in interpretation and contextualisation of the findings. The stakeholder group will provide advice about the language and terminology used in dissemination, encourage the implementation of findings and will take an active role in dissemination to other service users. The members of the research team have successfully used public-patient engagement strategies in their previous work, including funded systematic reviews. For example, applicants Gilbody, Palmer and Glanville used public-patient involvement as part of a HTA-funded review of screening methods for post-natal depression.

6.0 Research Governance 6.1 Funding Research funding has been secured from the National Institute of Health

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Research – Health Technology Assessment programme (reference: 09/169/07). 6.2 Trial Steering Committee (TSC) A TSC will be set up and will include an independent chair and at least two other independent members, along with the lead investigator and the other study collaborators. Two service users will join the steering group for collaboration on monitoring study progress. They will also be consulted on methods of dissemination of study findings for service users. They will meet at least annually (See Appendix 5 for details). 6.3 Day to day management of the trial The chief investigator (Barry Wright) will be in charge of the overall management of the trial. The York-based trial manager (TBA) will be responsible for the co-ordination of the study between sites. A trial coordinator and trial secretary will carry out the day to day activities involved in running the trial. Delivery of training on social stories will be carried out by a team of clinicians. A research fellow will be responsible for the qualitative components of the study. 6.4 Responsibilities of the applicants Barry Wright will act as the Chief Investigator with overall responsibility for the study and also act as the study mental health specialist. Barry Wright and members of the trial steering group will be responsible for study oversight, ensuring study milestones are met and adverse events are appropriately dealt with. Simon Gilbody, Dean McMillan and Rachel Richardson will provide expertise in evidence synthesis. Danya Glaser, Vivien Prior and Clare Whitton will provide content expertise experience in the field of attachment disorders. Julie Glanville and Steven Duffy will conduct will develop and conduct search strategies, and Mr Stephen Palmer will be responsible for application of decision-analytic modelling. Danielle Moore and Liz Littlewood will support with day to day running of research. Sharon McNeill will provide a service user perspective. Study finances will be managed by the project manager and research co-ordinator in collaboration with the local research finance manager and overseen by the Trust Finance Officer.

6.5 Dissemination of research findings We will begin to consider our dissemination strategy at an early stage of the project. As a basic step, we will publish the results of each of the phases of our programme of reviews in high profile journals and will present our findings at national and international conferences (many of the applicants have a strong track record in this respect). We recognise that successful dissemination requires a pre-planned strategy that considers the groups who need to be aware of the results of the review and the methods with which to communicate with these groups. Our stakeholder group will be ideally placed to help us identify key factors that will be important in our dissemination strategy. These will include characteristics of the audience to be targeted, appropriate communication channels and the wider working environment of

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our audiences. We are aware that this is a complex project likely to generate complex results and that planned dissemination will be crucial. We will seek separate funds to hold a research dissemination event for national and local clinicians and policy makers. References 1. Bowlby J. Attatchment and loss. Vol I. Attatchment London, New York: Hogarth, Basic books 1969. 2. Goldberg S. Attachment and development. London: Arnold; 2000. 3. Ainsworth MDS, Wittig BA. Attatchment and exploratory behavior of one-year-olds in a strange situation. In: Foss BM, editor. Determinants of Infant Behavior IV. London: Menthuen; 1969. p. 111-36. 4. Ainsworth MDS, Blehar MC, Waters E, Wall S. Patterns of attachment. Hillsdale, NJ: Lawrence Erlbaum Associates, Inc.; 1978. 5. Main M, Solomon J. Discovery of disorganised/disorientated attachment pattern. In: Brazelton TB, Yogman MW, editors. Affective development in infancy Norwood NJ: Ablex; 1986. p. 95-124. 6. Main M, Soloman J. Procedures for identifying infants as disorganized/ disoriented during the Ainsworth strange situation. In: Greenberg M, Cichetti D, Cummings EM, editors. Attachment in the Preschool Years: Theory, Research and Intervention. Chicago: University of Chicago Press; 1990. 7. Crittenden PM. Attachment and psychopathology. In: Goldberg S, Muir R, Kerr J, editors. John Bowlby's attachment theory: Historical, clinical, and social significance. New York: Analytic Press; 1995. p. 367-406. 8. Crittenden PM. Maltreated Infants : vulnerability and resilience. Journal of Child Psychology and Psychiatry. 2006;26(1):85-96. 9. World Health Organisation. The ICD-10 classification of mental and behavioural disorders. Geneva: World Health Organisation 1992. 10. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. Washington DC: American Psychiatric Association; 2000. 11. Boris NW, Zeanah CH. Disturbances and disorders of attachment in infancy: An overview Infant Mental Health Journal. 1999;20(1):1-9. 12. AACAP. Practice Parameter for the Assessment and Treatment of Children and Adolescents With Reactive Attachment Disorder of Infancy and Early Childhood. Journal of the American Academy of Child and Adolescent Psychiatry. 2005;44(11):1206-19. 13. Cassidy J, Marvin RS. Attachment organization in preschool children: Procedures and coding manual. Unpublished manual1992. 14. Nicholson J, Sweeney EM, Geller JL. Focus on women: mothers with mental illness: I The competing demands of parenting and living with mental illness. Psychiatric Services. 1998;49:635-42. 15. Craig EA. Parenting programmes for women with mental illness who have young children: A review. Australian and New Zealand Journal of Psychiatry. 2004;38:923-8. 16. Riley A, Valdez C, Barrueco S, Mills C, Beardslee W, Sandler I, et al. Development of a family-based program to reduces risk and promote resilience among families affected by maternal depression: theoretical basis and program description. Clinical Child and Family Psychology Review. 2008;11:12-29.

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17. Manning C, Gregoire A. Effects of parental mental illness on children. Psychiatry. 2008;8(1):7-9. 18. Van Ijzendoorn MH, Bakermans- Kranenburg MJ. Attachment representations in mothers, fathers, adolescents, and clinical groups: A meta-analytic search for normative data. Journal of Consulting and Clinical Psychiatry. 1996;64(8):8-21. 19. O'Connor TG, Croft CN. A twin study of attachment in pre-school children. Child Development. 2001;72:1501-11. 20. Bokhorst CL, Bakermans- Kranenburg MJ. The importance of shared environment in mother-infant attachment security: A behavioral genetics study. Child Development. 2003;74:1769-82. 21. Bakermans-Kranenburg MJ, IJzendoorn MHv. Research Review: Genetic vulnerability or differential susceptibility in child development: the case of attachment. Journal of Child Psychology and Psychiatry. 2007;48(12):1160-73. 22. Rutter M, Kreppner J, Sonuga-Barke E. Attachment insecurity, disinhibited attachment, and attachment disorders: Where do research findings leave the concepts? Journal of Child Psychology and Psychiatry. 2009;50(5):529-43. 23. Rutter M. Clinical implications of attachment concepts. Hertzig ME, Farber EA, editors. Philadelphia: Brunner/Mazel; 1996. 24. O’Connor TG, Byrne JG. Attachment Measures for Research and Practice. Child and Adolescent Mental Health Volume 2007;12(4):187-92. 25. Main M, Kaplan N, Cassidy J. Security in infancy, childhood, and adulthood: A move to the level of representation. In: Bretherton I, Waters E, editors. Growing points of attachment theory and research: Monographs of the Society for Research in Child Development; 1985. p. 1-2. 26. Bartholomew K, Horowitz LM. Attachment styles among young adults: A test of a four-category model. Journal of Personality and Social Psychology. 1991;61:226-44. 27. Muris PA, Merckelbach HA, Gadet BA, Moulaert VA. Fears, Worries, and Scary Dreams in 4- to 12-Year-Old Children:Their Content, Developmental Pattern, and Origins. Journal of Clinical Child Psychology. 2000;29(1):43-52. 28. Hazan C, Shaver PR. Romantic love conceptualized as an attachment process. Journal of Personality and Social Psychology. 1987;59:511-24. 29. George C. A representational perspective of child abuse and prevention: Internal working models of attachment and caregiving Child Abuse & Neglect. 1996;20(5):411-24. 30. Steele H, Steele M, Croft C, Fonagy P. Infant–mother attachment at one year predicts children’s understanding of mixed emotions at six years. Social Development. 1999;8:161-77. 31. Crowell JA, Fleischman MA. Use of structured research procedures in clinical assessments of infants. In: Zeanah CH, editor. Handbook of infant mental health. New York: Guilford; 1993. p. 210–21. 32. Cowan P, Cohn D, Cowan C, Pearson J. Parents' Attachment Histories and Children's Externalizing and Internalizing Behaviors: Exploring Family Systems Models of Linkage. Journal of Consulting and Clinical Psychology. 1996;64(1):53-63.

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33. Deater-Deckard K, Petrill SA. Parent-child dyadic mutuality and child behavior problems: Gene-environment processes. Journal of Child Psychology and Psychiatry. 2004;45:1171-9. 34. Marchand JF, Schedler S, Wagstaff DA. Parents' adult attachment representations, depressive symptoms, and conflict resolution strategies: Predictors of children's behavior problems. . Early Childhood Research Quarterly. 2004;19(3):449-62. 35. Speltz ML, Greenberg MT, DeKleyn M. Attachment in preschoolers with disruptive behaviour: a comparison of clinic-referred and nonproblem children. Development and Psychopathology. 1990;2:31-46. 36. Futh A, O'Connor TG, Matias C, Green J, Stephen S. Attachment narratives and behavior and emotional symptoms in an ethnically diverse, at risk sample. Journal of the American Academy of Child and Adolescent. 2008;47:709-18. 37. Leschied A, Chiodo D, Whitehead P, Hurley D. The relationship between maternal depression and child outcomes in a child welfare sample: Implications for treatment and policy. Child and Family Social Work. 2005;10:281-91. 38. Adam KS, Sheldon-Keller AE, West M. Attachment Organization and History of Suicidal Behavior in Clinical Adolescents. Journal of Consulting and Clinical Psychology. 1996;64(2):264-72. 39. Raskin A, Boothe HH, Reatig NA, Schulterbrandt JG, Odel D. Factor analyses of normal and depressed patients’ memories of parental behavior. Psychological Reports. 1971;29:871-9. 40. Van Ijzendoorn MH, Feldbrugge JTTM, Derks FCH, De Ruiter C, Verhages MFM, Philipe MWG, et al. Attachment representations of personality-disordered criminal offenders. American journal of Orthospsychiatry. 1997;67(3):449-59. 41. Warren SL, Huston L, Egeland B, Sroufe LA. Child and adolescent anxiety disorders and early attachment. Journal of the American Academy of Child and Adolescent Psychiatry. 1997;36:637-41. 42. Loman MM, Wiik KL, Frenn KA, Pollak SD, Gunnar MR. Post institutionalized children's development: Growth, cognitive, and language outcomes. Developmental and Behavioral Pediatrics. 2009;30:426-34. 43. Modinos G, Aleman A, Ormel J. Cortisol levels in childhood and psychosis risk in late adolescence. Journal of the American Academy of Child and Adolescent Psychiatry. 2009;48(7):765-6. 44. Grossman K, Grossman K, Kindler H. Early care and the roots of attachment and partnership representations. In: Grossman K, Grossman K, Waters E, editors. Attachment from infancy to adulthood: The major longitudinal studies. New York: Guilford Press; 2005. 45. Greenberg M. Attachment and psychopathology in childhood. In: Cassidy J, Shaver PR, editors. Handbook of attachment: Theory, research and clinical applications. New York: Guilford Press; 1999. 46. Wienfield N, Sroufe LA, Egeland B, Carlson E. The nature of individual differences in infant-caregiver attachment. In: Cassidy J, Shaver PR, editors. Handbook of attachment : Theory, research and clinical applications. New York: Guilford Press; 1999. 47. Juffer F, Bakermans-Kranenburg MJ, IJzendoorn MHv. Attachment-based interventions: Heading for evidenced-based ways to support families.

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Occasional Papers from the Association for Child and Adolescent Mental Health. 2009;29:47-57. 48. Dretzke J, Frew E, Davenport C, Barlow J, Stewart-Brown S, Sandercock J, et al. The effectiveness and cost-effectiveness of parent training/education programmes for the treatment of conduct disorder, including oppositional defiant disorder, in children. Health Technology Assessment. 2005;9(50 iii, ix-x):1-233. 49. Department for Education and Skills. Every child matters: Change for children. London: DfES; 2004. 50. HM Government. Children’s Act. London: TSO; 2004. 51. HM Treasury. Choice for Parents, the Best Start for Children: A Ten Year Strategy for Childcare. Norwich: TSO; 2004. 52. Department of Children Schools and Families. The Children’s Plan: Building brighter futures. London: DCSF; 2007. 53. Department of Children Schools and Families. Statutory Framework for the Early Years Foundation Stage. London: DCSF; 2008. 54. Centre for Social Justice. Breakthrough Britain: The Next Generation. A policy report for The Early Years Commission. London: The Centre for Social Justice; 2008. 55. Department of Health. The Child Health Promotion Programme: pregnancy and the first five years of life. London: Department of Health; 2008. 56. Department of Health. National Service Framework for Children, Young People and Maternity Services. 2004. 57. Department of Health. Delivering Health Services through Sure Start Children’s Centres. London: DH; 2007a. 58. Olds D. The Nurse-Family Partnership: An evidence-based preventive intervention. Infant Mental Health Journal. 2006;27(1):5-25. 59. Juffer F, Bakermans- Kranenburg MJ. Attachment-based interventions: Heading for evidenced-based ways to support families. Occaissional papers from the Association for Child and Adolescent Mental Health. 2009;29:47-57. 60. Centre for Reviews and Dissemination. Undertaking Systematic Reviews of Research on Effectiveness: CRD report 4. York: University of York2009. Report No.: 4. 61. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions 5.0.2 Chichester UK: John Wiley & Sons, Ltd; 2009. 62. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. British Medical Journal. 2003;327:557-60. 63. Higgins JPT, Thompson SG. Controlling the risk of spurious findings from meta-regression. Statistics in Medicine. 2004;23:1663-82. 64. Paulden M, Palmer S, Hewitt C, Gilbody S. Screening for postnatal depression in primary care: cost effectiveness analysis British Medical Journal. in press. 65. Hewitt CE, Gilbody SM, Brealey S, Paulden M, Palmer S, Mann R, et al. Methods to identify postnatal depression in primary care: an integrated evidence synthesis and value of information analysis. Health Technology Assessment. 2009;13(36):1-230. 66. Centre for Reviews and Dissemination. Making cost effectiveness information available: the NHS Economic Evaluation Database project: CRD Report 6. York1996. Report No.: 6.

Page 31: NETSCC, HTA

30

Attachment Protocol 23 June 2011 Version 2

67. Drummond MF, O’Brien B, Stoddard GL, Torrance GW. Methods for the Economic Evaluation of Health Care Programmes. Oxford: Oxford University Press; 1997. 68. Brennan A, Akehurst R. Modelling in health economic evaluation: What is its place? What is its value? Pharmacoeconomics. 2000;17:445-59. 69. Philips Z, Ginnelly L, Sculpher M, Claxton K, Golder S, Riemsma R, et al. Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technology Assessment. 2004;8(36):1-158. 70. Fenwick L, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Economics. 2002;10:779-87. 71. Claxton K, Ginnelly L, Sculpher M, Philips Z, Palmer S. A pilot study on the use of decision theory and value of information analysis as part of the NHS Health Technology Assessment programme. Health Technol Assess. 2004;8(31):1-103. 72. Claxton K, Sculpher M, Drummond M. A rational framework for decision making by the National Institute for Clinical Excellence (NICE). The Lancet. 2002;360(9334):711-5. 73. Wright B, Ashby B, Beverley D, Calvert E, Jordan J, Miles J, et al. A feasibility study comparing two treatment approaches for Chronic Fatigue Syndrome in Adolescents. Archives of Disease in Childhood. 2005;90:369-72. 74. Wright B, Williams C. Intervention and Support Programme for Parents and Carers of Children and Young People on the Autism Spectrum. A Resource for Trainers. London and Philadelphia: Jessica Kingsley Publishers; 2007. 75. Pillay M, Alderson-Day B, Wright B, Williams C, Urwin B. Autism Spectrum Conditions Enhancing Nurture and Development (ASCEND): An evaluation of intervention support groups for parents. Clinical Child Psychology and Psychiatry. in press. 76. Gilbody S, Whitty P, Grimshaw J, Thomas R. Educational and organizational interventions to improve the management of depression in primary care: a systematic review. Journal of the American Medical Association. 2003;289:3145-51. 77. Gilbody S, Whitty P, Grimshaw JG, Thomas R. Improving the recognition and management of depression in primary care: University of York2002. 78. Gilbody SM, House AO, Sheldon TA. Routinely administered questionnaires for depression and anxiety: a systematic review. British Medical Journal. 2001;322: 406-9. 79. Prior V, Glaser D. Understanding Attachment and Attachment Disorders: Theory, Evidence and Practice London: Jessica Kingsley Publishers; 2006. 80. Hewitt C, Gilbody S, Mann R, Brealey S. Instruments to identify post-natal depression: Which methods have been the most extensively validated, in what setting and in which language? International Journal of Psychiatry in Clinical Practice. 2009(0):1-9. 81. Hewitt CE, Gilbody SM. Is it clinically and cost effective to screen for postnatal depression: a systematic review of controlled clinical trials and economic evidence. BJOG: An International Journal of Obstetrics & Gynaecology. 2009;116(8):1019-27.

Page 32: NETSCC, HTA

31

Attachment Protocol 23 June 2011 Version 2

82. Hewitt CE, Gilbody SM, Brealey S, Paulden M, Palmer S, Mann R, et al. Methods to identify postnatal depression in primary care: an integrated evidence synthesis and value of information analysis. Health Technology Assessment Journal. 2009;13(36):1-230. 83. Hewitt CE, Perry AE, Adams B, Gilbody SM. Screening and case finding for depression in offender populations: A systematic review of diagnostic properties. Journal of Affective Disorders. in press. 84. Paulden M, Palmer S, Hewitt C, Gilbody S. Screening for postnatal depression in primary care: cost effectiveness analysis. British Medical Journal. 2009;340:b5203. 85. Mann R, Gilbody S, Adamson J. Prevalence and incidence of postnatal depression: what can systematic reviews tell us? Archives of Women's Mental Health. 2010:1-11.