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Standard Operating Procedure IMAGEN Follow-up 3 study

September 2016

Recruitment and Home Assessment

Contents

General Overview ............................................................................................................................... 2

Recruitment .......................................................................................................................................... 3Home Assessment .............................................................................................................................. 5

General Guidance ........................................................................................................................... 5

Psytools Tokens Set-Up ................................................................................................................. 7

Participant Home Assessment .................................................................................................... 11

New measures and adaptations ..................................................................................................... 12

Participant Psytools core assessment battery .......................................................................... 12

Participant DAWBA core assessment battery .......................................................................... 14

Participant optional assessment battery .................................................................................... 14

Reliability and Completion Checks ................................................................................................. 15

Telephone Interview with the Participant ....................................................................................... 17

Additional Incentives and Home Visits ........................................................................................... 20

Home Visit Guidance .................................................................................................................... 20

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General Overview

1. The third follow-up (FU3) is due to commence once the participant assessed at baseline will turn 22 +

a minimum of 3 months (if participant is older than this does it does not preclude their participation).

In addition, if the participant has been assessed in FU2, the time interval between the two follow-up

assessments (FU2 and FU3) should not be shorter than 18 months.

2. The FU3 assessment will follow the same format as the baseline assessment and occur in two

phases: Home Assessment and Institute Assessment.

3. All eight FU3 sites will assign staff to organise the Home and Institute Assessments at their own site.

4. Ethical approval will be obtained at each site for the Follow-Up 3 study as soon as possible.

Templates for the amended ethics application including information sheets for participants will be

provided by London describing the measures and procedure in detail.

5. Participants will be contacted by email/letter/telephone asking for their consent to participate in this

phase of the study. If written consent can be obtained, log-in details will be sent via mail. If the

adolescent does not consent, they will be contacted via phone asking them about their recent

substance use (as consented before).

6. Incentives: We suggest that the participants receive £/€ 100 after the completion of all core tasks

(home and institute assessments).

7. In Psytools, a question will ask for their consent to be re-contacted in the future with information

regarding a possible further follow-up assessment.

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Recruitment

The FU3 assessment starts once the participants assessed at baseline turn 22 years old (+ a minimum of 3

months). However, the time interval between the two follow-up assessments (FU2 and FU3) should not be

shorter than 18 months.

Participants should be telephoned/emailed to discuss taking part in the third follow-up. The call/email should

relay a brief summary of what participation at FU3 entails, giving a quick outline of both the institute visit and

also the home assessment. Participants’ contact details should be confirmed (address, mobile phone number,

email address), and updated when necessary, during this correspondence. This should be used to generate

interest in the study and to ensure that the IC packs are being sent to the correct address.

At this stage, information letters and consent forms are sent to the participant asking them to participate in the

FU3 assessment. Participants will be sent an Informed Consent (IC) Pack containing:

1. Cover letter

2. Study information sheet

3. A consent form

4. MRI exclusion criteria sheet

5. A self-addressed envelope

Participants should also be directed to the IMAGEN study website (www.imagen-europe.com) where they can

get detailed information on Follow-up 3. They may also contact the different sites through the website with any

queries or comments. Participants may also view the English-speaking social media sites for the IMAGEN

study where they can get in contact and be kept up to date with the progress of the study. There is a

Facebook page www.facebook.com/IMAGEN-Study and also a Twitter account “@ImagenStudy”. French and

German sites may include social media as part of their recruitment process however; this must be done in

accordance with their ethical permissions and discussed with their site leaders.

FU3 progress at each site will be reported weekly during a teleconference.

A flow chart detailing how recruitment and assessment completion should progress can be seen on Fig 1.

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Figure 1: Follow Up 3 Recruitment Strategy and Home Assessment Flowchart.

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Home Assessment

General Guidance

The home assessment consists of 23 core measures and 8 optional measures for the participant (Psytools

battery), the Adult DAWBA and the optional IMAGEN PATHWAYS questionnaires.

The home assessment may be completed at any computer/tablet/phone with an internet connection that is

available to the participant, either at the participant’s home or elsewhere. If there is no such device available,

the research team can give the participant the opportunity to do the home assessment at the research

institute. In those cases, travel costs will also be reimbursed. Home visits may also be offered in line with your

ethical permissions.

Upon receiving signed consent forms, participants will then be ready to be invited on the Delosis system

(https://www.delosis.com/qs/index.php/admin/authentication/sa/login) - you can search for a specific PSC /

name / email and invite people one at a time. Each site should receive an administration login from John

Rogers. In order to invite participants, you will first be required to generate tokens for each participant. Please

follow the instructions in the Psytools Tokens Set-Up section. The participant may complete the

assessment battery at his/her leisure, but will be given a recommended timeframe in which to complete the

tasks (2 weeks).

Once the tokens have been generated, participants can then be invited to complete the questionnaires. The

invitation email will look like such:

Dear {FIRSTNAME}, you have been invited to participate in some surveys as part of IMAGEN Follow-up 3.

Instructions for Psytools, DAWBA, and the optional IMAGEN PATHWAYS are below. All your answers are

completely confidential and anonymous.

Psytools: We have a new online format for Psytools that will allow you to complete the questionnaires by

phone or tablet! To participate, please click on the link below.

Click here to do the survey: {SURVEYURL}. If you do not want to participate in this survey and don't want to

receive any more invitations please click the following link: {OPTOUTURL}

DAWBA: Please visit {http://dawba.net}. After selecting English/German/French as your language, please

enter your personalised ID number (xxxx) and your password (yyyy). Then select the appropriate

information regarding your age, gender, etc, clicking on the ‘advance’ arrows when finished.

Please begin the interview by filling out the Strength and Difficulties Questionnaire. After finishing, you will be

brought to the central checklist of all sections that are part of the assessment. The sections you need to

complete are in red; once you complete a section it will be written in blue. You can stop at any point and

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return to the section you last answered by visiting the website, entering your login information, and selecting

the option "I want to change some sections of the interview — please list these.” (Please change this last part

of the sentence to what it says in your language for the FU2 Psytools document mailed to participants.)

IMAGEN PATHWAYS: Since you consented to participate in the additional IMAGEN-PATHWAYS study,

please visit the included link to complete the additional questionnaires and tasks.

Click here to do the IMAGEN PATHWAYS survey: {SURVEYURL}

If you have any concerns, comments, or technical problems at all please contact the team by email (site

email) or telephone (site telephone).

Before sending of this email, you will be required to manually enter the DAWBA ID and Password linked with

the specific participant you are inviting. Please ensure that you have pre-linked DAWBA IDs and Passwords

to a particular PSC1 as shown in the Psytools Token Set-up section. Please ensure that you enter the

right DAWBA ID and password for the particular participant. If the participant had not consented to

participate in the IMAGEN PATHWAYS study (i.e. ERANID), please remove that section of the email before

sending it off. Once the email has been sent, the participant should have received all the necessary details to

complete the full home assessment.

Between two and three weeks after log-in details are sent to the participants, the online questionnaires

(Psytools and DAWBA) are checked for completion and data reliability (see the Standard Procedure for

Reliability section). If the participant has completed the tasks, a phone call should be made to thank them for

taking part so and also to confirm the institute visit date if this has not already been arranged. If online

completion is totally or partially outstanding, the participants are contacted via telephone/email to prompt them

to complete the assessment. If data quality is flagged as doubtful, the participants are contacted via telephone

to clarify the doubtfulness of the data to be able to either a) give a final reliability rating and/or b) ask them to

redo the assessment in case of bad reliability. The assessment must be re-checked after the participant has

re-completed the questionnaires. If the participant has not completed the Home Assessment before the date

for the Institute Assessment, participants should be contacted 3-5 days prior to the institute visit to remind

them to complete the online questionnaire. Inform them that if they do not do so, they will be required to

arrange for additional time during their visit to complete the online questionnaires at the research institute.

If the participants do not agree to complete both the Home and Institute FU3 assessment, they will be offered

the following options (i) to complete the Home Assessment only (Psytools and DAWBA) or (ii) to complete a

telephone interview. The telephone interview consists of the AUDIT and ESPAD where the instructions are

slightly adapted so the interview may be conducted verbally. Where volunteers have not supplied written

consent, please ensure you ask whether they consent to be re-contacted at a later date for further follow-up

assessments. Please work within the limits of your own ethical governance regarding written consent.

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In order to collect and store all relevant data per participant, the same excel file used in baseline, FU1 and

FU2 should be used. All new data and updates, e.g., individual contact details, assessment dates and

completion as well as further comments will be entered. For FU3, in addition to the information mentioned

below please also create a column that calculates the interval between FU2 and FU3 assessment points.

Each site is responsible for providing a secure data storage and backup strategy of this password locked

sample file (“SITE data base.xls”).

Psytools Tokens Set-Up

Instructions to link PSC1 codes with Psytools tokens and DAWBA codes

Click on Token Management:

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Click on Import tokens from CSV:

Choose csv/excel file to upload (eg. FUIII_token_upload_template) :

Note: If you are using Excel and have accented characters then you should specify the character set

of the file to be Windows west european.

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The csv/excel file should look like this. Please ensure you open this template in Google Sheets or

if you will to use Excel then you have to save it as a csv and open it in Notepad++ (please see

important note*** below). The participant’s PSC1 code should be scanned/entered into the

Study_ID column (red arrow). Please ensure the Participant ID is the 12-digit PSC1 code followed

by FU3 (in capitals) <eg. 012345678912FU3>. Please also enter the DAWBA ID and DAWBA

Passwords for the corresponding participant. This template will be sent to all sites:

*Note: You can keep updating and importing the same template throughout the study since

participants that have already been uploaded will automatically be excluded since there are

duplicates.

**Please ensure that you pre-match all the DAWBA IDs and DAWBA Codes to the PSC1

codes using this template. This will help to avoid any human errors with typing in the codes

and causing any mismatching that occurred during FU2.

***Important Note: If you are encountering errors in the uploading of the csv file, please ensure that

you are editing the document in Googlesheets. If you are using excel, please save the file as a csv.

After which, open it in Notepad++ (not the general notepad!) and click the encoding menu - select

encode in UTF-8, and then save so that you have a properly encoded file before you upload.

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Once the CSV/excel file has been uploaded, click on Display tokens:

Click on Generate Tokens (tokens will be generated for new participants that do not have one yet):

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Participant Home Assessment

Participants will answer a 2-staged battery, the core battery plus one optional part containing additional

measures.

Participant

Core Assessment:

1) AUDIT Alcohol Questionnaire (2 min)

2) NEO Personality I (3-4 min)

3) ESPAD Drug Questionnaire (10-12 min)

4) TCI-R Personality II (6 min); (novelty seeking)

5) SURPS Personality III (2-3 min)

6) KIRBY Now or later? (2-3 min)

7) LEQ (Adult version) Life Events (2 min)

9) CES-D Your Mood I (5 min)

9) TFEQ Eating Habits I (3 min)

10) CAPE 42 Feelings and Experiences (5-10 min)

11) BIS Thinking and Acting (3-5 min)

12) ANXDX Your Feelings (3-5 min)

13) URBANICITY Urbanicity (3-5 min)

14) BSI Symptom Questionnaire (12 min)

15) WHO-5 Well-being Questionnaire I (2 min)

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16) PANAS Feelings and Emotions (5 min)

17) CID-S Well-Being Questionnaire II (2 min)

18) HRQOL Quality of Life Questionnaire (2 min)

19) K6+ Your Mood II (2 min)

20) PHQ-8 Health Questionnaire (1-2 min)

21) PSS-10 Stress Questionnaire (3 min)

22) BRFSS Health and Function (5 min)

23) SCAMP Questions about telephone use (2-3 min)

Optional Assessment:

1) MAST Alcohol Questionnaire II (3-5 min)

2) IRI Personality IV: Relating to other people (3-5 min)

3) CSI-24 Physical Symptoms Questionnaire (3-5 min)

4) RSQ Feelings and Thoughts (3 min)

5) Video Games Video-Gaming (3-5 min)

6) TCI3 Personality V (5 min); persistence, reward dependence, harm avoidance

7) EDEQ Eating Habits II (3-5 min)

NOTE: All instructions, item and response wording and labels of all Psytools measures including the FU and

FU_INTERVIEW measures can all be found in the Psytools resources excel file (see respective tags of

worksheet labels). This will be made available online on Milliarium as soon as the final release is available. No

summary variables have been created for the new measures included.

New measures and adaptations

Participant Psytools core assessment battery

1. BSI-53

The Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1983) is a widely used 53-item questionnaire in

which participants rank each item on a 5-point scale ranging from 0 (not at all) to 4 (extremely) in the past

week by various symptoms. Rankings represent the intensity of distress over the past week. It is a shortened

version of the Symptoms Checklist-90 and covers nine symptom dimensions of depression:

• Somatization

• Obsession-compulsion

• Interpersonal sensitivity

• Depression

• Anxiety

• Hostility

• Phobic Anxiety

• Paranoid Ideation

• Psychoticism

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2. PANAS

The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report measure of positive and negative

affect developed by Watson, Clark, and Tellegen (1988b). It asks participants to rate the extent to which they

experienced each feeling/emotion on a 5-point Likert Scale ranging from “very slightly” to “very much”. The

PANAS is believed to provide independent measures of Positive Affect (PA) and Negative Affect (NA). Since

its development the measure has been employed in research for diverse purposes. Its popularity is attributed

to its brevity and its close association with an influential conceptualization of anxiety and depression: the

tripartite model (Clark & Watson, 1991b; Crawford & Henry, 2004).

3. WHO-5 Well-Being Index

Three global indices of distress are also used: Global Severity Index, Positive Symptom Distress Index, and

Positive Symptom Total. These measure number and intensity of reported symptoms, as well as current or

past level of symptomatology.

4. PSS-10

The Perceived Stress Scale (PSS) is a widely used self-report instrument to measure nonspecific stress (S

Cohen et al. 1983). The original version contained 14 items but a shorter version will be used this study. It

consists of 10 questions asking how often in the last month has their life been difficult/stressful. They item

responses are on a 5-point Likert scale ranging from "Never" to "Very Often". Measuring non-specific stress,

compared to only measuring specific stressors, is important as it accounts for the subjective interpretation of

stressors. This subjective interpretation may influence how a person experiences and manages a particular

stressor.

5. Selected questions from the BRFSS

The Centers for Disease Control and Prevention (CDC) Behavioral Risk Factor Surveillance System (BRFSS)

is a survey used to ask US residents about health risks and chronic conditions

(http://www.cdc.gov/brfss/questionnaires/index.htm). Psychopathology, such as depression, often presents

itself with somatic comorbidities (i.e., cardiovascular disease, cancer, diabetes). Therefore, 18 questions have

been selected asking about their general physical health, if their health has affected their usual activities,

sleep frequency/quality, and whether or not they've been diagnosed with chronic conditions (i.e., heart

problems, stroke, cancer, kidney disease, diabetes).

6. CES-D

To assess depression in the IMAGEN sample the Adolescent Depression Rating Scale was previously used.

This will be replaced with the Center for Epidemiological Studies Depression Scale (CES-D; LS Radloff 1977).

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It is a short (20-item) self-report scaled used to measure depression symptoms in a general population and

has been used extensively in research.

7. SCAMP Mobile questionnaire

The Mobile phone questionnaire is a 13-item questionnaire modified from the SCAMP study (Imperial College

London) provided by Prof Mirielle Tolenano. It asks about the mobile phone usage, (i.e., frequency of phone

calls, texting/messaging behavior, internet/App usage).

Participants are asked whether they consent in being re-contacted for further follow-up before the optional

part with the additional measures is displayed.

Participant DAWBA core assessment battery

Similar to FU2, at FU3, only the participant will be assessed using the DAWBA. No informant (parent) data will

be acquired at this stage. The DAWBA version used at FU3 will be the same as that used during FU2, the

Adult DAWBA version aimed at young adults. The Adult DAWBA questionnaire is very similar but is adjusted

to life stage (wording and psychopathologies). The following modules were added to the questionnaire for

FU2: (1) Antisocial personality disorder; (2) Alcohol and substance use; (3) Psychosis. The following modules

were removed from the questionnaire: (1) Separation anxiety, (2) Oppositional / Conduct Disorder, (3) Autistic

spectrum.

Participant optional assessment battery

After finishing the core assessments an option to continue with further assessments will be displayed on the

screen to the participants (Table 1). At this stage participants will be told that they can earn extra incentives if

they finish this second optional set of tasks. Please note that extra incentives do not apply to Paris.

1. CSI-24

A shortened version of the Children's Somatization Inventory Revised Form (CSI-24; LS Walker 2009) will be

used in place of the 35-item CSI questionnaire used in previous study time points. This questionnaire is also

suitable for use in adults (AL Sherman 2012). The assessment of different somatic symptoms including pain

allows IMAGEN researchers to examine the association of symptom experience with behavioural, neural and

genetic mechanisms of risk taking and emotional processing in adolescents. The CSI includes items from the

symptom criteria for somatization disorder as defined by the DSM-III-R, items from the Somatization factor of

the Hopkins Symptom Checklist (HSCL; Derogatis et al., 1974). The standard time period for symptom report

on the CSI is 2 weeks. The response format is a 5-point scale ranging from ‘‘not at all’’ (0) to ‘‘a whole lot’’(4).

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Participant optional IMAGEN PATHWAYS questionnaires

1. Alcohol Self-Concept Scale (ASCS) and the Cannabis Self-Concept Scale (CSCS)

The two questionnaires are explicit measures of alcohol and cannabis identity. Both scales contain 5

statements (e.g., "Drinking is part of who I am") with answer options ranging from "0" (strongly disagree) to "9"

(strongly agree).

2. Implicit Association Test (IAT; Greenwald & Farnham 2000) and the Cannabis version of the IAT

The IAT measures strengths of associations between concepts. Participants are instructed to classify words

as belonging to one of two target categories (e.g., "alcohol" and "non-alcohol") or two attribute categories

(e.g., "me" and "not-me") as fast as possible. Participants' reaction times when categorizing stimuli will be

recorded.

3. Additional Questions

For those who have reported using cannabis in the past year, they will be shown photos of 5 different

cannabis types. Three questions will be asked: 1) What type(s) they have tried in the past year; 2) How many

days they have used each type in the past 3 months; and 3) How accessible they find each type of cannabis

on a scale of 1 (I can never access it) to 7 (I can always access it).

Reliability and Completion Checks

Psytools Reliability Checks

The Psytools home assessment checks for FU3 are now done on via email.

Please check the completion and validity of the home assessment with Psytools before you give the

final incentive.

1. When the participant has completed their Psytools assessment, the site administrator should receive

an email as shown below:

Hello Name/IMAGEN FU3,

A new response was submitted for your survey '{SURVEYNAME}'. PSC1 {TOKEN:ATTRIBUTE_1}

THIS RESPONSE REQUIRES INVESTIGATION - Refer PSC1 to London. Click the following link to see the individual response: {VIEWRESPONSEURL}

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All responses will produce an email saying what PSC has just completed and ones that require

investigation have a big red sentence telling them so.

2. If this red sentence is shown in the email, a validation check is required and the London site will check

the reason for this. Please email the subject’s PSC1 code to the address imagen-psytools@kcl.ac.uk.

3. The London site will then check the data and tell you what the problem is (see below).

Guidance for if you need to call participants after London tells you what problem is:

Tell the participant that an automatic system highlighted some of their answers and this is why we get back to

them to clarify these flags.

Subject indicates, they are in a hurry” or "would change answers if had more time" Please ask the participant if they took their time to do the task. If this is doubtful, please ask them to redo the

task.

“Another person is watching” or "would change answers if in a different location" Please ask the participant if they answered the questions on their own and also if they felt the confidentiality of

their answers were compromised. If not so, ask them to redo the task.

“Distracting noise” or “Listening to music” Please ask them if they switched off the noise or switched off the music before they ran the task. If not, please

ask them to do the task again.

“All responses being the same” or "Filled out questionnaire too quickly" Please ask them if they were in a hurry or understood the task well and offer help. Then ask them to do the

task again.

“Drug Semeron indicated as known or taken” Please let the participant know that this drug is quite unusual and hard to get and let the participant describe in which context they might have heard its name or how they got hold of it. The reliability rating then depends on the participant’s explanation. When reliability is doubtful, redoing the task is not recommended but just

entering a comment in Psytools.

Please note the results of the validation check and the potential repetition in the reliability table in the

CRF.

General recommendation:

Please let the London site know as soon as possible about validity check failures as participants should redo

the doubtful tasks before they finish with the assessment and receive their incentives.

Please note that Doubtful data is considered Bad data. Therefore, it’s important to make a decision whether

the data is either Good or Bad before entering the reliability into Psytools. Bad data should be entered with a

comment, as well as Good data linked to a validation flag.

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DAWBA reliability should be also checked during the phone call by asking the participant whether they had

any problems while completing it and whether they had enough time to do so (please see DAWBA reliability

checks below).

TLFB reliability will be entered into Psytools.

In order to enter the reliability of the data into Psytools, each research site should install Psytools from the

website listed below using the site-specific player code and key.

The links to download the Psytools programme are:

1. for the English and Irish site http://www.imagen-europe.com/study-english/,

2. for the German site http://www.imagen-europe.com/study-deutsch/,

3. for the French site http://www.imagen-europe.com/study-francais/.

This installation enables the researchers to access the “participant” and the “institute” log-in for every “family”

at their research site. In order to enter the reliability checks, the family group code should be entered and

the “institute” log-in chosen. The password used should also be the “institute” password.

The “institute” log-in shows the Reliability button for entering the participant’s data reliability information for

both DAWBA and Psytools questionnaires.

If the participant has chosen to do the telephone interview please refer to the next section, “Telephone

Interview with a participant”, in this SOP.

DAWBA Reliability Checks

1. Please go to the website www.dawba.net, select English/French/German and enter the DAWBA ID number, the ID number is NOT the pseudocode (PSC).

2. To check the completion of the DAWBA please enter the DAWBA ID into the DAWBA web page and click next. Please enter the DAWBA code into the password box. Press the forward button and the page below will be displayed.

3. Click the same grey forward button.

4. At this point select the second option ‘I want to change some sections of the interview, please list these’

5. This then displays a list of DAWBA sections; the completed sections are coloured blue. When all sections are blue (apart from the bottom one) then you know your participant has completed the tasks. If sections are red, in addition to the bottom line, then your participant still has some work to do.

6. When you check a new person you need to reload the web page – www.dawba.net

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Telephone Interview with the Participant

Situations that may arise during a phone interview:

- Busy

- Not interested

- Loud

- Not alone

- Hangs up abruptly

How to start the conversation:

1) Introduce yourself (e.g.: Hi xxxxx, this is xxxx phoning from the IMAGEN study, do you remember

us?). Thank them for their contribution at Baseline and/or FU1 & FU2. Be cheerful.

2) Ask if it is a good time to go through the interview (if s/he is not busy or in a hurry). Inform about the

length of the interview (approximately 30 min) and say that it is split into 2 parts.

- If s/he says he has enough time to do it now, then you must check:

o If s/he’s alone

If the participant is not alone it is important to inform him/her that the questions you will ask are quite

personal, and check that they would not answer any differently with someone nearby. If the participant

indicates they would answer differently, arrange another time to call them back. If the participant is not

fazed then assure them all of the answers will be kept confidential.

o If it’s quiet around

If the participant is not in a quiet environment ask if s/he will be able to focus on the interview despite the

noise. If YES, get started with the interview but be attentive to the fact s/he may get distracted because of

the noise. If that happens, you may offer a break as soon as you finish the 1st half (ESPAD) and arrange

to call back later to do the 2nd

half (AUDIT).

- If s/he says s/he is not interested in doing the interview anymore, check whether they are not

interested in general or whether the situation is simply inconvenient. Mention again that the interview

can be split into two 15 minute sections and remind the participant that they will be reimbursed £ (€)

10 for their time. If they are willing to complete it, arrange a time to call back and check if the number

you called is the best one to contact them on.

3) If the call disconnects phone back and check if the participant is still interested in doing the interview.

If they state it is not a good time anymore, try and arrange another time to phone back.

4) IN GENERAL:

• Always be very friendly and support them. Make it as easy and convenient as possible for them to do

the interview.

• Show understanding and try not to put any pressure on them.

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• Try to build up a good rapport by e.g. mentioning things you learned about them earlier (hobbies etc),

validate their current mood, be cheerful

• Try and create an atmosphere of a “chat with a good friend”

• Try to guide them through the questions quickly to avoid fatigue

• Be patient and repeat yourself as many times as the participant asks for it

HELPLINES

In case a participant reveals that they are suffering from suicidal thoughts or are planning to harm themselves

or others, ask whether they have anybody to support them in this matter. Also offer help either a) by giving

helplines or b) by putting them in touch with the local clinician. For this purpose, it is important to have a

helpline and a clinician available for the participants at each site; the contact details of both should be readily

available to you. They can also be offered a visit to the Institute if they would rather speak to the clinician in

person. Should the participant disclose any other distressing issues, please follow this procedure.

If a case like this ever happens to you, be sure to contact and inform your supervisor and the respective

clinician about this situation immediately.

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Additional Incentives and Home Visits

Extra reimbursement to encourage quicker completion of the assessments, and home visits for the hard cases

are recruitment procedures that were used during FU1 and FU2 will be part of FU3.

1) In certain cases where participants express interest in taking part but have difficulty returning their informed

consent forms or booking an appointment for an assessment, an additional incentive of up to £/€ 20 may be

offered should they get in touch to book an appointment by a certain deadline. The full incentive will then be

given when the participant fully completes the institute assessment and home assessment.

2) Participants who have difficulty completing their home assessment and who require numerous reminder

calls can be offered an additional incentive of up to £/€ 50 to complete their home assessment by a specified

deadline./

3) Home visits should be offered to those participants who have agreed to be visited (during prior telephone

calls) (not applicable to Paris). These more difficult cases are those participants who have agreed to take part

in the study 6+ months ago but have not finished the assessment. Despite the fact that these participants are

willing to take part in the follow-up assessment, there are some instances where they cannot find time to

complete the assessment. The home visit should be arranged via phone and we suggest that it take place

either in the family home or in the nearest library. The researcher should carry a portable computer with

internet access and assist the family during the assessment.

Home Visit Guidance

1) On the phone, introduce yourself and be cheerful. If the participant’s completion is outstanding,

please schedule a home visit with the participant only.

2) We recommend the following statements may be used as a loose script

a. “We would like to thank you for your contribution to the study so far. Actually, we have been

contacting you because of the good data you previously provided the IMAGEN study, and we

would be very grateful if you were able to take part in this part of the study now, it would be

such a great help. “

b. “If you feel you’re able to help it would be great if we could complete this as soon as possible

as we have a fairly strict deadline too. We would really like to schedule a home visit for some

time during the next week so we can have the assessment completed, do you think this might

be possible? Obviously we’ll work around your schedule. When will be best for you?”

21

At this point, please also explain how the home visit works: A researcher will come to the participant’s house

(or nearest library) with a laptop, which the participant will use to fill in the questionnaires.

4) Please schedule a date/time for the visit. If it is not possible during the coming week, please arrange it for

the week after. If necessary, explain again the importance of having the assessment completed as soon as

possible due to the timeframe of the project.

Focus Group and Study Experiences Survey In order to get a greater understanding of participants’ experiences and opinions towards the IMAGEN Study,

focus groups and participant surveys can be conducted at the end of the phase. These allow the study to gain

feedback from participant on their experiences of the study, how to increase their engagement with the study

and what improvements can be made in future phases.

All participants who have completed some or all of the home assessment or the institute assessment and

have consented to be contacted in the future should be invited to give feedback. All eligible participants

should be simultaneously sent an email and a letter with details of the focus group. These emails and letters

should include an information sheet regarding the focus group and the intended dates on which the focus

groups will be held. Participants should be asked to contact the study via either email, Facebook or phone by

a certain deadline should they wish to reserve a place on the focus group. Participants should be informed

that they will receive £25 in reimbursement for attending the focus group. A wide spread of potential dates for

the focus groups, including weekends, should be offered to the participants to ensure that as many

participants can attend as possible. Participants should be notified that the two most popular dates for the

focus group will be selected once the deadline has ended and the participants who expressed an interest will

then be contacted with the full details of the focus group including the time and location.

Additionally, a copy of the study experiences survey, an information sheet regarding the survey and a prepaid

addressed envelope should be included within this initial mailshot. Participants who are unable to attend the

focus groups can still give feedback through this format and should be asked to complete the anonymous

study experiences survey and return it via post. They will also be given the option of returning the completed

survey via email but they will be reminded that their survey responses will no longer be completely

anonymous.

The focus group should take approximately one hour, consist of 5-10 participants, and should be based on a

pre-decided list of open ended questions and topics. Before commencing the focus group, all participants

should sign an informed consent form. It should be explained to them that because the researchers cannot

control what participants reveal once the group has finished, confidentiality cannot be completely guaranteed.

The focus group should be recorded using two Dictaphones.

22

APPENDIX Please find in this section the documents that should be sent to the participants in the IC pack (items 1-5)

along with a stamped self-addressed return envelope. You'll also find focus group related documents (items 6-10) that can be sent towards the end of Follow-up 3:

1 Cover letter

2 Study information sheet for the adolescent

3 A adolescent consent form

4 MRI exclusion criteria sheet

5 A self-addressed envelope

6 Letter for Focus Group & Study Experiences Survey

7 Focus Group Information Sheet

8 Study Experiences Survey Information sheet

9 Focus Group Informed Consent

10 Study Experiences Survey

23

Institute of Psychiatry

MRC - SGDP De Crespigny Park Denmark Hill, London SE5 8AF

TEL: 020 7 848 0824

THE IMAGEN STUDY – FOLLOW-UP 3 First signs of mental disorders may already be present in childhood. Often the way somebody reacts to reward and punishment and how they can control themselves are connected with these disorders. This research will thus hopefully help to find out the biological and social causes

of mental disorders and how the brain responds to different kinds of information.

Dear IMAGEN participant, First of all, thank you very much for all your support so far! It’s been almost four years since you took part in our last Follow-up study. Through

these follow-ups, we hope to find out how your attitudes and behaviours might have changed over time.

We are now moving on to the next stage of the IMAGEN Project, which is the third Follow-up assessment. We would like to invite you to be

part of it. The third Follow-up will be split in two sections: the home-based and the Institute-based sections. The home-based section includes two sets of online questionnaires, similar to those that you’ve seen before but with a few new additions, to be completed at home.

The Institute-based section involves a few quick computer tasks, a short brain imaging session using the same tasks you’ve done before, and an approximately 30-minute interview. Also, we would like to ask you for a hair and blood sample. As a thank you for your time and effort,

we can offer you £100 (plus reimbursement of travel expenses). We can also offer you an extra £10 if you opt to complete an additional,

shorter set of questionnaires after having completed the sets of questionnaires mentioned above. This additional set, however, is optional and you can decide on the go whether you would like to continue with this assessment or not. In addition, if you consent to giving a hair

sample and complete three online assessments, we will offer you an additional €15 (£13) as well.

Like in the second Follow-up, to take part in this extended study you need to give us your consent. Please sign the enclosed consent form and send it back to us in the stamped addressed envelope provided. Further information is included in the enclosed information

sheet. After receiving the forms, we will send you a letter detailing how to answer the questionnaires online. In addition, we will contact you to arrange the visit to the Institute of Psychiatry in order to complete the Institute-based section.

Should you prefer not to participate in the extended follow-up, we can alternatively conduct a brief telephone interview as intended in our

original study design. We will give you a call to check that you are still happy to take part and to arrange a convenient time. You will be offered

£10 for your time.

Please remember that all information given as part of the IMAGEN project is kept strictly confidential. This is a voluntary project and there is no obligation to take part. If you have any further questions, please contact us at the details given below and we will get back to you as soon

as possible.

The project has been a great success so far due to your generous participation. We thank you again for your ongoing support.

The IMAGEN Team

Contact: Nicole Tay nicole.tay@kcl.ac.uk 020 7848 0824

24

INFORMATION SHEET FOR PARTICIPANTS

Participant Information Sheet Version May 2016 Ref. PNM/10/11-126

Institute of Psychiatry

MRC - SGDP

De Crespigny ParDenmark Hill, London SE5 8AF

TEL: 020 7 848 0824

YOU WILL BE GIVEN A COPY OF THIS INFORMATION SHEET

IMAGEN STUDY – Third FOLLOW-UP Assessment

First of all, thank you very much for taking part in the previous stages of our IMAGEN study. With your second Follow-up assessment, you assented to be contacted for a third Follow-up about 3-4 years later.

With this study information sheet we would like to inform you about our third follow-up assessment in which we would like you to take

part. If you do not want to sign up for this online assessment, we will contact you to see whether you are still interested to take part in the brietelephone interview.

Reward related behaviour in the normal brain and psychopathology We would like you to take part in an additional component of our research study. Before you decide if you would like to participate we want to

make sure that you understand the purpose of this follow-up study and that you make a well informed decision as to whether you wish to participate or not.

Background and goal of the study 25 out of 100 persons will eventually become mentally ill sometime during their life-time. First signs of these disorders may already be presen

in childhood. Often the way somebody reacts to reward and punishment and how he/she can control him/herself are connected with mental disorders. This research will thus hopefully help to find out the biological and social causes of mental disorders and how the brain responds to

different kinds of information. With the Follow-up assessments, we will be able to repeatedly assess and compare the information you gave us

at about 14, 16-17 and 18-19 years of age with those given at the age of 22-23. This will enable us to see how your current and previous attitudes and behaviors are linked. We hope that the results of this study will prove useful in developing new treatments for preventing mental

illness in the future.

Who will participate in the study? A total of approximately 1600 22-23 year olds will be included in this multi-centre study in the UK, Germany, France and Ireland.

What would I have to do within the study? Psychological assessment:

You will be asked to complete some online questionnaires about your emotions, behaviours, and lifestyle. Furthermore, there will be sever

other questionnaires about your personality. In addition, we would like you to perform some tasks to understand how you would respond t

different kinds of information/situations.

After completing those questionnaires and the tasks, you will be offered an option on the computer screen to continue with some optionalassessments. This section includes answering some additional questionnaires about physical symptoms, video-gaming, your mood and your

relationship with others. All of these questionnaires will be similar to the ones you have answered at the previous IMAGEN assessment

These questionnaires can be run at your convenience on your computer/tablet/mobile phone. However, if you cannot run the online assessment at home, we will invite you to come to our institute and complete the assessment there.

25

The online computer assessment will take about 2½ h to complete, but you do not need to complete all the assessment in one go. The

website automatically saves what you have done so far and you can come back later to do more. The optional measures section will be much shorter and will take about 45 minutes to complete and we will offer you some additional reimbursement for your extra time and effort.

We will also ask you to participate in an assessment that will take place at the Research Institute (IoP) and will take around 3½ h to complete

Behavioral tasks and brain imaging: During the Institute assessment session, you will be asked to complete a number of tasks that measure your thought processes. When a

signal is presented, you will be required to press some buttons in response. Before each task begins, your will be told in detail what the task will be.

Hair sampling:

You will also be asked to provide a hair sample (1.5cm in diameter) if you consent to do so. The sample can be taken from multiple sites on the scalp (e.g., the nape of the neck) to prevent visible patches. If you have insufficient hair on your head to collect a sample, (e.g., bald or

shaved head), hair from the underarm can be used.

Your anonymised hair sample will be sent to a laboratory where drug analyses will be done. These analyses will provide an objective measur

of drug use. If you consent to providing a hair sample you will be sent a link to three new online assessments unique to this sub-study, called IMAGEN-PATHWAYS. You will be reimbursed for the sample and assessments.

Genetic analyses:

You will be asked to provide a blood sample (approximately 30 ml or 3 tablespoons) during the study. The sample will be sent to the laboratory, where DNA (the material containing your genes) and the proteins made by the DNA will be extracted. These will then be stored in

the refrigerator until the analyses are performed. Your genetic results and that of other study participants will then be analyzed together with the results from the psychological tests and the imaging studies. This will allow us to determine whether specific genes, either alone or in

combination with environmental factors, are associated with specific behavioral and imaging results, and with medical conditions.

Would there be any potential risks for me if I were to participate in the study? Psychological assessment:

The answering of the questionnaires, the interview and the reactions tests are not associated with any risks.

MRI studies:

MRI uses magnetic fields to produce pictures of your brain and of the activities in your brain. This does not hurt, does not involve radiation anis not dangerous. As MRI can interfere with magnetic body implants, nobody with those implants is allowed to participate in the study. This ca

occur, for instance, with large tattoos (which contain iron particles) or dental bridges. A trained medical doctor will investigate carefully if you will be allowed to enter the MR and take care that no harm can ensue. Furthermore he/she will ask you that you are not carrying any electroni

devices which can be damaged by the magnetic fields. So far, the effect of MR scanners on an unborn child is not known. In order to eliminat

any potential risk, if you are or might be pregnant, you have to be excluded from the study.

On the day of the MRI scan, you will again be examined for exclusion criteria like Claustrophobia (see below), pregnancy and metallic items attached to the body. In case an exclusion criterion is met, you will be excluded from any further participation in the study on the day of

scanning.

Claustrophobia:

Some persons undergoing an MRI may feel confined, closed-in, or frightened. We make sure that you have contact with the person conducting the examination, so that you can be removed from the magnet in less than 2 minutes.

Who will look at the images? Your images will be read by a qualified doctor, i.e. a radiologist, who is competent to report the study. If your images show no abnormality no

further action will be taken and you will not hear from us.

26

Incidental findings: What happens if the scan shows something unexpected?

If, however, some unexpected information of potential clinical importance is found on your images we will issue a written radiological report ofyour exam that will be sent to your GP if you have consented for us to do so. The images will be made available to other physicians as hard-

copy or on optical disk (CD) or other electronic image format. You should be aware that this is not a full diagnostic scan and we cannot guarantee that an existing abnormality will be identified in the images.

Blood taking and hair sample: You will be asked to provide a blood sample so that we can extract your DNA. As with all normal blood taking procedures, there is the

possibility of transient irritation such as mild bruising occurring at the location where the blood was taken.

There are no envisaged risks from the collection of hair. You may not wish to provide a hair sample for personal reasons and you will able to

refuse the sample without explanation.

What are the benefits to me of taking part in the study? Your willingness to participate in this study would be a very important contribution to the study of psychiatric diseases. You would help us to

broaden the scientific understanding of genetic and environmental influences on the development of psychiatric and related illnesses, which

will, in turn, lead to improved treatments and prevention. There is no direct personal benefit to you from participation in the study; however, you will receive a compensation for your time and effort. Travel costs will be reimbursed to facilitate attendance to scanning sections.

The study is performed for scientific purposes only, and thus no individual results, which may predict increased risk to develop mental disorde

can be made available. That means, it will not be possible to tell you if you are at increased risk for these disorders due to the investigations

we perform. It is the aim of the study to learn about biological and environmental risk factors for mental disorders. This knowledge then will help to develop prevention strategies and therapies.

If you wish to be given access to information regarding the scientific results of the overall study including all participants, this information will

be available to you. You will be sent a newsletter at the end of the study or earlier if indicated when we achieve results, which have meaningful

therapeutic consequences.

Results that may impact on your health Any unexpected results obtained during your assessment that have the potential to impact on your health will be communicated to you.

Unexpected findings may include:-

1. irregularities in imaging which require clarification (no responsibility is taken for false negative results, see above)

2. irregularities in psychological assessment which require clarification, treatment or intervention, e.g. depression, suicidality, history of either being a victim or having carried out of acts of aggression. However, the information assessed via the computer-based questionnaires will not

be available to the research assistants on the day of your completion and will not be screened systematically for adventitious findings. Such information will only be available for the London research team in case you disclose directly to a research assistant. You will also be invited to

contact the team at any later point if you wish. It is only in these cases where you directly disclose information about your own well-being that

we will be able to provide assistance to you.

Findings from genetic analyses will not be disclosed to you due to the anonymous nature of this information.

Will my data be handled confidentially?

Information revealed to us will remain confidential from the other members of your family. In the case of findings that may impact on your health, we will report to you and your GP if you have consented for us to do so. All personal data, e.g. name and address, will be kept strictly

separate from the questionnaires, the interview results, imaging data and the genetic tests. All medical information will be used in an anonymous form for scientific analysis. Personal data will not be disclosed to the scientists carrying out the statistical analyses.

In order to achieve the goal of the study, which is to identify the biological and environmental factors underlying psychiatric and psychological problems, we must collaborate internationally with scientists and also make the IMAGEN data available to the broader scientific community.

Sharing data reinforces open scientific inquiry, encourages diversity of analysis and opinion and promotes new research. The anonymity of your data will be protected. Data and DNA will be stored and analyzed for as long a time as they prove beneficial for the identification of

27

biological/environmental factors causing problem behaviours. Storage and work on clinical data and DNA will always be in accordance with

the current ethical guidelines, and the conditions of the informed consent obtained form you.

What would happen if I did not want to continue with the study?

Participation in this study is entirely voluntary. You may withdraw your consent at any time during the study. You do not need to explain or

justify your reasons for withdrawing, and it will not have any adverse effects on you. If you wish your data and your DNA will then be

destroyed. However, once anonymized data has been transferred to the database it will no longer be possible to withdraw your data or samples, as it will not convey your identity.

Further Questions?

If you have any further questions, please do not hesitate to contact us at: 0207 848 0824. We are happy to answer all the questions you may

have concerning this study.

28

CONSENT FORM FOR Participants

Participant consent form May 2016 – Ref. PNM/10/11-126

Institute of Psychiatry

MRC - SGDP

De Crespigny Park Denmark Hill, London SE5 8AF

TEL: 020 7 848 0824

IMAGEN STUDY – Third FOLLOW-UP Assessment

Reward related behaviour in the normal brain and psychopathology To participate in this research, read and sign this form. To consent to each aspect of the research, please initialize the boxes below. If you wish to opt out of a particular aspect of the research then do not initialize that box.

Initials

1. I have read the attached information sheet on the third follow-up

component of the above project, dated May 2016 (Ref. PNM/10/11-126), and

have been given a copy to keep. I have had the opportunity to ask questions about

the project and understand why the research is being done and any foreseeable risk

s involved.

2. I understand that the information provided by me will be

pseudoanonymized and entered into a study database. I understand how the

information will be collected and stored indefinitely. I understand my personal

data will not be shared with anyone outside the research team or my clinical team;

instead data will be linked via a code.

3. I agree to my pseudoanonymized data being made available to other

scientific research groups for use in subsequent research projects. I understand

that this will not involve sharing of any personal information from which I could

be identified.

4. I consent to having a sample of blood taken for research in the above

project. I understand how the sample will be collected, that giving a sample for

this research is voluntary and that I am free to withdraw my approval for use of the

sample at any time without giving reason and without my legal rights being

affected.

5. I consent to giving a sample of hair for research in the above project. I

understand how the sample will be collected, that giving a sample for this research

is voluntary and that I am free to withdraw my approval for use of the sample at

any time without giving reason and without my legal rights being affected.

6. I understand that a newsletter about the research findings will be sent to

me.

7. I agree to my biological samples (blood) being transferred and stored on a

long-term basis at UK Biobank or another dedicated storage facility. I

understand this is so they can be used in future projects, aimed at understanding

genetic influences on disease and traits. These studies will be approved and may

include researchers from other universities or commercial companies.

8. I am willing to participate in a MRI scan. I understand that the scan will not

have any implications for me personally, and I will not get any test results.

29

9. I understand that very occasionally the researchers may discover an

unexpected finding during the study, which may have important implications

for my future health. I understand however that this is a scientific and not a

medical investigation and there is no guarantee that abnormalities will be detected.

I also understand that I have the right to decide whether I wish to be informed of

such findings.

10a. I wish for my GP to be informed of any unexpected findings that may

have important implications for my health and to contact me about such

findings.

10b. I do not wish to be contacted about any unexpected findings even though

they may have implications for my health and, therefore, do not want my GP

to be informed of any unexpected findings.

11. I understand that I will not benefit financially should this research lead to

the development of a new treatment or medical test. By signing this form I

consent to, and make no claim of right in, the unrestricted use of such samples for

genetic and other biological analysis.

12. I give permission for members of the research team or other research

teams to contact me in future to arrange a follow up interview or to invite me

to take part in other similar studies. I understand that if I am contacted, I will be

provided with full information about these additional studies and any future help is

voluntary and that I can refuse to take part without giving reason and without legal

rights being affected. I also understand any future studies will have ethical

approval.

13. I know how to contact the research team if I need to, and I am aware there is

an option to be kept up to date with the progress of the study.

14. I agree to participate in this study. I understand that if I decide at any time

during the research that I no longer wish to participate in this project, I can notify

the researchers involved and be withdrawn from it immediately.

.

Name of Participant Date Signature

(BLOCK CAPITALS)

30

Contraindications for Magnetic Resonance Imaging PLEASE COMPLETE THIS FORM AND SEND IT BACK WITH THE SIGNED PARTICIPANT CONSENT FORM.

INVITATION FOR PARTICIPANTS

Invitation for Participants Version May 2015 Ref. PNM/10/11-126

Do you wear any metal implants, e.g. braces or stents (other than fixed prosthodontics like crowns) or had any operations where metal has been inserted into the body?

□No □Yes

□Unknown □Not available

Do you wear electronic, magnetic or mechanic implants or devices, e.g. pacemakers or ear implants, or does your child wear non- removable piercings?

□No □Yes

□Unknown □Not available

Do you have any foreign metallic bodies in the eyes or do you have any shrapnel in the body? □No □Yes

□Unknown □Not available

Do you have any tattoos at the upper part of the body or permanent makeup? □No □Yes

□Unknown □Not available

Do you have a false limb? □No □Yes

□Unknown □Not available

Do you suffer from severe claustrophobia, i.e. do you fear enclosed or confined spaces? □No □Yes

□Unknown □Not available

Do you use any contraceptive methods such as pills, coils or diaphragms? □No □Yes

□Unknown □Not available

31

Institute of Psychiatry, Psychology & Neuroscience

MRC - SGDP De Crespigny Park

Denmark Hill, London SE5 8AF

TEL: 020 7 848 0824

Dear IMAGEN Study Participant, We are writing to invite you to give your view on your experience as a participant of the IMAGEN Study. We are running focus group sessions that will allow you to give us feedback on your interaction with the study team and how you think we

should improve. A focus group is a group of people who meet and discuss their personal experience of a certain topic, in this case taking part in IMAGEN. Each Focus Group session will be made up of 5-8 study participants and will last for

approximately one hour. We will hold the sessions at the MRC Social Genetic and Developmental Psychiatry Building at our Denmark Hill Campus. You will be reimbursed £25 for your time as well as for any reasonable travel expenses you

may incur.

Places at the focus group are limited and will be awarded on a first-come first-served basis so if you want to take part

please let us know by which dates you are able to attend. The groups will go ahead on the two dates upon which the largest number of people indicate they are available. It is important you tell us your availability for all of the proposed

sessions so that we can be as fair as possible in our selection of the best date and time.

Possible Focus Group Dates:

Please tell us which session you would like to attend by emailing imagenfollowup@gmail.com, sending us a message

on Facebook (www.facebook.com/IMAGEN-study) or twitter @ImagenStudy, or by calling the Study Team on 0207

848 0824.

We know that these dates will not suit all of our participants and so some of you will be unable to attend, however we still

want to hear your views on the study. If you would like to give feedback then you can complete the Study Experiences Survey. We have enclosed an information sheet and the study experiences survey; please read both documents very

carefully. If you have any questions please let us know.

Additionally please find attached the latest edition of our newsletter.

Thanks for all your help so far with the study.

Best wishes,

The IMAGEN Team

32

INFORMATION SHEET FOR PARTICIPANTS

Participant Information Sheet Version May 2015 Ref. PNM/10/11-126

Institute of Psychiatry, Psychology & Neuroscience

MRC - SGDP

De Crespigny Park Denmark Hill, London SE5 8AF

TEL: 020 7 848 0824

IMAGEN Study Focus Group Research – Information Sheet

We are inviting you to take part in a focus group being conducted by the IMAGEN Study at King’s College London.

What is a focus group? A focus group is a group of individuals selected to discuss and comment on, from personal experience, a certain topic.

This is in the form of a one hour long informal group discussion.

Why are you holding a focus group?

We want to learn more about your experience and interaction with the IMAGEN Study over the past few years. We will also ask you about your views on our new website, our newsletter & social media pages and ask how we can best keep

you, our participants, as well as your ,, interested in the study. This will help us to work out how we should interact with

you in the future.

Why am I being invited to take part in the focus group? You have previously taken part in the IMAGEN Study and indicated you were willing to be contacted for further

participation in the study.

What will the group involve?

Each Focus Group session will be made up of 5-8 study participants and will last for approximately one hour. We will hold the sessions at the MRC Social Genetic and Developmental Psychiatry Building at our Denmark Hill Campus. The

sessions will be run by members of the IMAGEN Study Team, Dr Erin Quinlan and Ms Nicole Tay. Audio-recording devices will be used to record the content of the discussion, which will be transcribed, anonymised, and made available to

members of the study site in London to analyse. If you would prefer to complete a written survey instead taking part in the

focus group, please complete the Study Experience Survey in this pack.

Will I be reimbursed for my time? Everyone who attends the focus group will be given £25 to thank you for your time. You will also be reimbursed for all

reasonable travel expenses.

What should I do now?

If you would like to take part please tell us!

Contact us using the information below and indicate which dates you are available to attend:

Because places at the focus group are limited and will be awarded on a first-come first-served basis so if you want to take

part please let us know by which dates you are able to attend.

Contact us You can reach the study team by phone, text, email, Facebook or twitter using the contact details below. We are happy to

answer all the questions you may have concerning this study.

33

Email: imagenfollowup@gmail.com

Facebook: www.facebook.com/IMAGEN-Study

Tel: +44 207 848 0824 Twitter: @IMAGENStudy Mobile: +44 7765 866 886

Will my data be handled confidentially?

Yes. You can say as little or as much as you wish. All information collected from you in the focus group will be transcribed

and anonymised by a member of the study team with whom you have not met. This will ensure that they will not be able to link the audio recording to the experience of interacting with you and therefore maintain confidentiality and anonymity. Any

identifying information you may disclose during the session such as name, address or date of birth will not be transcribed for analysis. All information discussed to the study team will be kept confidential and will not be disclosed to other

members of the study or your family. Storage and work on data will always be in accordance with the current ethical

guidelines, and the conditions of the informed consent obtained from you.

We will do our upmost to ensure that everything you mention at the focus group remains confidential. We ask that all participants in the focus group also respect the confidentiality of other member of the group. Please note however that we

will be unable to guarantee that other participants in the group will not disclose information discussed during the group once they leave.

What would happen if I did not want to continue with the focus group? Participation in this focus group is entirely voluntary. You can skip questions that you do not want to answer or leave the

group at any time. You do not need to explain or justify your reasons for withdrawing, and it will not have any adverse effects on you. Please note that because of the interactive and interdependent nature of the focus group it will be difficult

to withdraw any data you provide once the focus group has begun. Please contact the study team if you have any

questions about this.

What if I’m unhappy with the IMAGEN Study? If this study has harmed you in any way then please contact the Psychiatry, Nursing & Midwifery Research Ethics Sub-

committee who have granted this study ethical approval, using the following details:

Psychiatry, Nursing & Midwifery RESC

Email: pnm@kcl.ac.uk

Phone: Tel: 020 7848 4077 Address: Research Ethics Office,

5.12 Franklin Wilkins Building (Waterloo Bridge Wing), Waterloo Campus,

King’s College London

34

INFORMATION SHEET FOR PARTICIPANTS

Participant Information Sheet Version May 2015 Ref. PNM/10/11-126

Institute of Psychiatry, Psychology & Neuroscience

MRC - SGDP De Crespigny Park

Denmark Hill, London SE5 8AF TEL: 020 7 848 0824

IMAGEN Study Experiences Survey – Information Sheet

We are inviting you to complete a short survey for the IMAGEN Study at King’s College London.

What is the survey about? The Study Experiences survey is aimed at gauging your experiences and opinions of the IMAGEN Study. We will also ask

you about how we can best keep you, our participants, as well as your families, interested in the study. We want to learn more about your experience and interaction with the IMAGEN Study over the past few years. This will help us to work out

how we should interact with you in the future.

Why am I being invited to complete the survey?

You have previously taken part in the IMAGEN Study and indicated you were willing to be contacted for further participation in the study.

Will my data be handled confidentially? Yes. The survey will be completely anonymous. It will be used to improve how the IMAGEN Study engages and interacts

with our participants. The anonymity of your data will be protected. Storage and work on data will always be in accordance with the current ethical guidelines.

What would happen if I did not want to complete the survey? Participation in the survey is entirely voluntary. You do not need to justify your reasons for withdrawing, and it will not have

any adverse effects on you. You can skip questions that you don’t want to answer. Due to the anonymous nature of the survey, we will not be able to withdraw the data you provide once the survey has been returned to us by post.

How can I take part in the survey?

You can take part in the survey by completing the survey attached. This should only take you 5-10 minutes to complete.

The questions will be about your experiences of the IMAGEN Study and how you think we can improve. This survey is completely anonymous and so we would ask that you do not include any identifying information such as your name or

date of birth. Once you’ve completed the survey you can return it in the addressed pre-paid envelope we have sent you.

I have not received a letter with a prepaid envelope for taking part; can I return the survey via email?

We have tried to send an addressed prepaid envelope to your address so that you can take part in the survey completely anonymously. However not everyone will always receive our letters at their most current address. If you have not received

a prepaid envelope for taking part please contact us and we will send you a new envelope as soon as possible. If you wish you may return your completed survey to us via email. Please note that this will mean that your survey will not be

completely anonymous when we receive it. All surveys received by email will be treated confidentially. Your survey will be

separated from your email upon receipt to ensure the anonymity of your information.

Contact us You can reach the study team by phone, text, email, Facebook or twitter using the contact details below. We are happy to

answer all the questions you may have concerning this study.

Email: imagenfollowup@gmail.com Facebook: www.facebook.com/IMAGEN-Study

Tel: +44 207 848 0824 Twitter: @IMAGENStudy

Mobile: +44 7765 866 88

35

STUDY EXPERIENCES QUESTIONNAIRE FOR PARTICIPANTS

Study Experiences Questionnaire Version May 2015 Ref. PNM/10/11-126

Institute of Psychiatry, Psychology & Neuroscience

MRC - SGDP

De Crespigny Park Denmark Hill, London SE5 8AF

TEL: 020 7 848 0824

Study Experience Survey This is your chance to have your say! Thank you for taking a few minutes to let us know what you think about the IMAGEN Study and what we can do to improve. Your opinion is very important to us and we will be able to improve how

we do things with your help.

Please do not write your name or date of birth on this form. Please read each question carefully and circle the number

that best describes your experience. If you think that more than one answer is correct please choose the answer that would be correct for your experience when you have taken part at any stage of the study, not just the most recent time. If

you do not wish to answer the question that is fine, please leave the question blank and move to the next question.

Thank You!

Section 1 refers to all communication you have had with the IMAGEN Study Team over the past 2-3 years

1. Communication

General Strongly

Disagree

Disagree Neither

Agreenor

Disagree

Agree Strongly

Agree

No

Opinion

Iaminterestedinthefindingsofthe

IMAGENStudy

Iwouldliketoreceivemore

informationontheresultsofthestudy

Ireceivetoomuchcontactfromthe

IMAGENStudy

ThefollowingquestionsarerelatedtotheIMAGENStudyNewsletter

Newsletter Yes No No

Opinion

IhavereceivedtheIMAGENStudy

Newsletter

Ifyouhavereceivedthenewsletter,

haveyoureadit?

36

Strongly

Disagree

Disagree Neither

Agreenor

Disagree

Agree Strongly

Agree

No

Opinion

Ifyouhavereadthenewsletter,did

youfindthecontentinteresting?

Never Oncea

year

Twicea

year

Four

times

ayear

Howoftenwouldyouliketoreceive

theIMAGENstudynewsletter?

ThefollowingquestionsarerelatedtotheIMAGENStudyFacebookAccount

www.facebook.com/IMAGEN-Study

Facebook Yes No No

Opinion

IuseFacebook

IfyouuseFacebook,haveyouheardof

theIMAGENStudyFacebookPage

IcurrentlyfollowtheIMAGENstudyon

Facebook

ThefollowingquestionsarerelatedtotheIMAGENStudyTwitterAccount

@IMAGENStudy

Twitter Yes No No

Opinion

IuseTwitter

IfyouuseTwitter,haveyouheardof

theIMAGENStudyTwitteraccount

IfyouuseTwitter,doyoufollowthe

IMAGENstudyonTwitter

Wecurrentlytweetaboutawide

rangeofthingsontwitter-pleasetell

uswhatyou’remostinterestedin

hearingaboutfromus.

Strongly

Disagree

Disagree Neither

Agreenor

Disagree

Agree Strongly

Agree

No

Opinion

Iwouldprefermoredetailed&serious

contentfromtheIMAGENStudy.

(exampletweetbelow)

37

Strongly

Disagree

Disagree Neither

Agreenor

Disagree

Agree Strongly

Agree

No

Opinion

Iwouldprefermorelight-hearted

informationfromtheIMAGENStudy

(exampletweetbelow)

Strongly

Disagree

Disagree Neither

Agreenor

Disagree

Agree Strongly

Agree

No

Opinion

Iwouldprefermoreadviceandtips

fromtheIMAGENStudy(example

tweetbelow)

Post Email Mobile

Phone

Home

Phone

Face-

book

Twitter

Mypreferredmethodofcontactis…

Why?

38

Section 2 refers to any contact between you and the IMAGEN study when you were contacted about taking part in the

second follow up (in the last 2-3 years)

2. Deciding to take part Strongly

Disagree

Disagree Neither

Agreenor

Disagree

Agree Strongly

Agree

No

Opinion

The person who contacted me made me

feel comfortable.

Strongly

Disagree

Disagree Neither

Agreenor

Disagree

Agree Strongly

Agree

No

Opinion

I understood what the assessment would

involve before I visited.

I was provided with enough information.

The person who arranged for my consent

form to be returned and spoke to me about

the study was skilled & professional at what

s/he did.

I was not given enough options for

appointment times

I would have preferred more weekend

appointment times

Is there anything else we should know?

Section 3 refers to the Home Assessment you completed as part of the second follow up (in the last 2-3 years). If you did not complete the Home Assessment then please leave this section blank and move to the next section.

3.HomeAssessment Strongly

Disagree

Disagree Neither

Agreenor

Disagree

Agree Strongly

Agree

No

Opinion

I thought that the Home Assessment was

too long

I found the instructions easy to follow.

I was provided with enough information.

I found the Home Assessment interesting

I feel that £20 was fair compensation for

completing all of the core questionnaires

Is there anything else we should know about

the Home Assessment?

39

Section 4 refers to the Institute Appointment. If you did not visit us then please leave this section blank and move to the

next section.

4.InstituteAssessment Strongly

Disagree

Disagree Neither

Agreenor

Disagree

Agree Strongly

Agree

No

Opinion

The researcher made me feel comfortable.

The tasks I performed were easy to

understand.

The tasks were interesting.

The researcher appeared skilled and

professional at what s/he did.

I enjoyed the MRI Scan

I thought the assessment day was too long.

I feel that the amount of vouchers I received

was a fair compensation for my time

If you do not think the compensation value

is fair please tell us what amount would be

fair, in your opinion.

£ _____

Is there anything else we should know about

the Institute Assessment?

Thinking about the whole day, did you find it (please tick one):

Organised and professional

A bit confusing but it went OK

Very confusing and disorganised, need to improve

And thinking about the whole day... What

was the best bit for you?

40

What was the worst bit for you?

Section5referstoanyfuturephasesoftheIMAGENStudytheremaybe.

5. Future Participation Strongly

Disagree

Disagree Neither

Agreenor

Disagree

Agree Strongly

Agree

No

Opinion

I am likely to take part in the IMAGEN Study

again

Receiving a picture of my brain scan would

encourage me to take part

Watching a video about the IMAGEN study

would be interesting to me

The iPad Prize draw motivated me to take

part in the IMAGEN Study again.

I am able to find information about the

IMAGEN Study if I want to.

Please suggest any other ways not

mentioned that would make you more likely

to take part in the IMAGEN Study again?

What else can the IMAGEN Study do for

you?

Please let us know if there is anything

else that you think the IMAGEN Study

should be doing?

41

Pleasereturnthecompletedsurveyto:TheIMAGENStudy,Instituteof

Psychiatry,Psychology&Neuroscience,16DeCrespignyPark,LONDON,

SE58AF.

Thankyoufortakingthetimetocompletethissurvey.