Online PTSD Treatment for Young People and Carers - Case Series
Phase: NA
Conditions: Post Traumatic Stress Disorder
Sponsor: King's College London

OPTYC case series protocol 
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OPTYC: Online PTSD Treatment for 
Young People and Carers 
 
 
CASE SERIES PROTOCOL 
 
 
 
Version 2 
20th February 2019 
 
 
Funding 
Medical Research Council  
Developmental pathway Funding Scheme (DPFS) 
MRC reference: MR/P017355/1 
 
 

OPTYC case series protocol 
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Roles and responsibilities  
Sponsor 
Joint IoPPN / SLaM 
R&D Office 
Room W1.08, Institute of Psychiatry 
Psychology & Neuroscience (IOPPN), 
King’s College London, SE5 8AF 
Telephone 020 7848 0339Email: slam-
ioppn.research@kcl.ac.uk  
Chief Investigator 
Dr Patrick Smith 
Psychology Department, IOPPN,  
King’s College London, SE5 8AF 
Telephone 020 7848 0506 
Email: patrick.smith@kcl.ac.uk 
 
Co-Investigators 
Prof David M Clark 
Oxford University 
Telephone: 01865 281607 
Email: david.clark@psy.ox.ac.uk 
 
 
Prof Anke Ehlers 
Oxford University 
Telephone: 01865 618600 
Email: anke.ehlers@psy.ox.ac.uk 
 
 
Prof Tim Dalgleish 
MRC Cognition and Brain Sciences Unit 
Cambridge 
Telephone: 01223 273685 
Email tim.dalgleish@mrc-cbu.cam.ac.uk 
 
 
Prof Richard Meiser-
Stedman 
University of East Anglia 
Telephone: 01603 593 601 
Email: R.Meiser-Stedman@uea.ac.uk 
 
 
Prof William Yule 
Psychology Department, IOPPN,  
King’s College London, SE5 8AF 
Telephone: 020 7848 0217 
Email: william.yule@kcl.ac.uk 
 
 
Dr Kimberley 
Goldsmith 
Biostatistics Department, IOPPN,  
King’s College London, SE5 8AF 
Telephone: 0207 848 0059 
Email: kimberley.goldsmith@kcl.ac.uk 
 
 

OPTYC case series protocol 
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Trial steering committee 
Role 
Name 
Responsibilities  
Chair 
Professor Cathy Creswell,  
Professor of Developmental Clinical Psychology, 
NIHR Research Professor, 
School of Psychology and Clinical Language 
Sciences, 
University of Reading 
Email: sxs03cc@reading.ac.uk 
Phone: 0118 378 6798 
Chair and 
independent 
clinician 
 
Professor Rachel Calam 
Emeritus Professor 
Division of Psychology and Mental Health 
University of Manchester  
Independent 
clinician 
 
Dr Andrew Brand 
Trials Statistician 
School of health Sciences 
Bangor University  
Independent 
statistician 
 
Ms Stacey Kelly-Maher 
Service user 
representative 
 
Dr Patrick Smith 
King’s College London 
PI 
 
Dr Kim Goldsmith 
King’s College London 
Co-I, Trial 
statistician 
 
Professor Richard Meiser-Stedman  
University of East Anglia 
Co-I, clinician, 
site lead for UEA 
 
Dr Ewan Carr 
King’s College London 
Trial statistician 
Declaration of interests 
Smith, Clark, and Yule are co-authors of a book on which the interventions are based, and they 
receive royalties from sales of the book.   
Smith, Dalgleish, and Meiser-Stedman occasionally deliver clinical workshops about the face to 
face intervention and may receive fees for doing so.   
There are no other potential conflicts of interest. 
 

OPTYC case series protocol 
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Contents 
 
1. Introduction  
 
7 
 
 
 
 
 
 
2. Objectives and Design  
 
8 
 
 
 
 
3. Participants 
 
13 
 
 
4. Analysis 
 
14 
 
 
5. Procedures 
 
15 
 
6. Data handling 
 
16 
 
7. Assessment of Safety 
 
20 
 
8. Oversight arrangements 
 
23 
 
9. Ethics and Regulatory approvals 
 
24 
 
10. Finances 
 
24 
 
11. Dissemination  
 
24 
 
 
 
 

OPTYC case series protocol 
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Study Synopsis 
Full Title 
OPTYC: Online PTSD Treatment for Young People and 
Carers 
Acronym 
OPTYC 
Protocol version number and Date 
 
Version 2 
20th February 2019 
Study Duration  
 
4 months (May 2019 to September 2019) 
Study Design 
 
Case series  
Sponsor/Co-sponsors  
 
Joint IoPPN / SLaM R&D Office 
Chief Investigator 
 
Patrick Smith 
REC number 
 
TBC 
Primary objective 
 
To develop and evaluate an Internet-delivered Cognitive 
Therapy (iCT) programme for the treatment of PTSD in 
adolescents. 
Secondary objective (s) 
 
To run an uncontrolled case series 
 
Number of subjects 
N = 6 
 
Main inclusion criteria 
 
Young people (12-17 years) whose main presenting 
problem is PTSD (diagnosed according to DSM-5 criteria) 
following a single-event trauma (e.g. serious accidents or 
assaults) will be included. 

OPTYC case series protocol 
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Main exclusion criteria 
Young people with brain damage, learning difficulty, 
ongoing trauma-related threat, recently started treatment 
with medication, or receiving another psychological 
treatment, will be excluded. 
Statistical methodology and 
analysis 
 
We will report on Reliable Clinical Change on a 
standardised questionnaire measure of PTSD symptoms 
(CPSS-5, detailed below); and we will obtain qualitative 
feedback from young people, carers, and therapists about 
their experience of using the programme. 
 
 

OPTYC case series protocol 
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1. Introduction 
The proposed study 
The primary objective is to develop and evaluate an Internet-delivered Cognitive Therapy (iCT) 
programme for the treatment of PTSD in adolescents. 
First, we will develop a secure, interactive, multi-media, iCT software program, designed 
specifically for adolescents, to be delivered on computers, tablets, and smart phones.  
Second, we will evaluate this new iCT programme in a case series. In the case series, the new 
iCT programme will be used to treat N = 6 patients with PTSD. The objective of the case series 
is to gauge acceptability of the programme to young people, carers, and therapists; to measure 
adherence to the programme; to gauge acceptability of the battery of measures; and to measure 
clinical change on symptoms measures.   
The population to be studied 
Young people (12-17 years) whose main presenting problem is PTSD (diagnosed according to 
DSM-5 criteria) following a single-event trauma (e.g. serious accidents or assaults) will be 
included. 
Summary of findings from previous studies 
PTSD is prevalent among young people, and is distressing and impairing. Face-to-face trauma-
focused CBT (TF-CBT) is an effective short-term therapy for PTSD in young people. Our group 
has developed Cognitive Therapy for PTSD (CT-PTSD) in children and young people, and 
shown in 2 published RCTs that it is efficacious. However, most young people with PTSD do not 
receive effective, evidence-based treatments. This is in part due to under-capacity in NHS 
CAMHS, and in part due to the burden and inconvenience to young people in attending face-to-
face appointments in a clinic. In this project we propose to make CT for PTSD widely available 
to young people by delivering the therapy via the internet, with therapist support. The rationale 
for this approach is that (1) young people will engage with internet-delivered therapy, and online 
therapies for other disorders such as depression have demonstrated efficacy in clinical trials; (2) 
effective online therapies for adults with PTSD have been developed and evaluated; (3) no 
online treatments for young people with PTSD have yet been developed. 

OPTYC case series protocol 
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2. Study Objectives and Design 
 Study Objectives 
2.1.1 Primary Objective 
To develop and evaluate an Internet-delivered Cognitive Therapy (iCT) programme for the 
treatment of PTSD in adolescents.   
Our initial evaluation of this new iCT-PTSD intervention will be made using a case series 
design. 
2.1.2 Secondary Objectives 
The objectives of the case series are: 
1. to gauge acceptability of the programme to young people, carers, and therapists 
2. to measure adherence to the programme 
3. to gauge acceptability of the battery of measures 
4. to obtain estimates of reliable clinical change on a standardised measure of PTSD 
symptoms (CPSS-5, see below) 
 Study Design 
We will complete a development case series with N=6 young people. The inclusion and 
exclusion criteria are described below.  
We will allow iterative development of the intervention and its delivery during the case series, if 
needed.  We will achieve this by staggering the start of treatment as far as practical so that 
feedback from patients who start early can be used to amend modules for patients who start 
later. 
 Study Outcomes 
2.3.1 Acceptability of iCT 
To gauge acceptability of iCT-PTSD, we will carry out post-treatment qualitative interviews with 
N=6 young people, their carers, and their therapists.  We will summarise interview data using 
content analysis.  Young people will also be asked to complete ratings of acceptability at the 
end of treatment, using a 0–100 scale (to measure design appeal, ease of use, comprehension, 
likelihood of recommending to a friend with similar problems). 
 

OPTYC case series protocol 
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2.3.2 Adherence to iCT  
To gauge adherence to iCT, we will report: 
1. Number of times logged into the programme per week and in total;  
2. Time spent logged in per week and in total and according to device used (phone, 
tablet, computer);  
3. Number of modules completed in total and according to device used (phone, tablet, 
computer); 
4. Number of therapist phone calls per week and in total; 
5. Time spent on phone calls per week and in total;  
6. Number of messages to / from therapist per week and in total. 
 
2.3.3 Outcome measures 
Clinical interview with young people and carers:  
1. Clinician Administered PTSD Scale for Children and Adolescents CAPS-CA-5 
(Pynoos et al 2015), administered by trained reliable interviewers. 
Questionnaire measures of PTSD, anxiety, and depression completed by young people:  
2. Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001) 
3. Children’s Revised Impact of Event Scale (CRIES; Perrin et al 2005) 
4. Revised Children’s Anxiety and Depression Scale RCADS-C; Chorpita & Ebesutani 
2014) 
5. Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016) 
Questionnaire measures of emotional and behaviour problems, and depression and anxiety 
completed by carers: 
6. Revised Children’s Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 
2014) 
7. Strength & Difficulties Questionnaire (SDQ-P; Goodman, 2001) 
 
We will also collect economic data on health utilities and resource uses using the  
8. Child Health Utility Index (CHU-9D, Stevens, 2012) 
9. Child & Adolescent Service Use Schedule (CA-SUS, Shearer, 2018) 
 
 

OPTYC case series protocol 
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2.3.4 Acceptability of questionnaire battery  
Acceptability of the questionnaire battery will be assessed by asking young people to complete 
an end-of-treatment rating using a 0–100 scale (rating the extent to which they agree with the 
statement, “I think other people of my age would be willing to fill in the questionnaire pack 
before and after treatment”), and including a space for free text feedback.   
 
2.3.5 Clinical change 
We will report appropriate descriptive statistics for all outcomes at each time point  (e.g. mean 
and standard deviations for continuous outcomes where possible; counts and percentages for 
categorical outcomes).  Initial signal of clinical effect will be indexed using Reliable Change on 
the CPSS (see below) i.e. a change of >= 14  points on this scale.  The purpose of re-
administering the questionnaire pack at 10 month follow up is to determine whether any 
treatment gains are maintained for these 6 young people.   
 
 

OPTYC case series protocol 
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 Study Timeline for the case series 
MEASURE 
 
STUDY PERIOD 
(w = week; m =  month) 
 
 
 
Screen 
0-1w 
Pre 
0w 
Weekly 
Mid 
0+6w 
Post 
0+4m 
Post 
0+10m 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ENROLMENT 
 
 
 
 
 
 
 
Eligibility screen 
 
x 
 
 
 
 
 
Provide study information 
 
x 
 
 
 
 
 
Gain informed consent 
 
 
x 
 
 
 
 
 
ONLINE ASSESSMENT 
DAWBA 
 
 
 
x 
 
 
 
 
INTERVIEW 
 
 
 
 
 
 
 
DEMOGRAPHIC INTERVIEW 
 
 
x 
 
 
 
 
CAPS-CA-5 
 
 
x 
x 
 
 
x 
 
CGAS  
 
 
x 
 
 
X 
 
 
 
 
 
 
 
 
 
ADOLESCENT 
QUESTIONNAIRES 
 
 
 
 
 
 
 
CPSS-5 
 
 
x 
 
 
X 
  X 
CRIES-8 
 
 
x 
x 
x 
x 
  X 
RCADS-C 
 
 
x 
 
 
x 
  X 
CPTCI 
 
 
x 
 
x 
x 
  X 
CHU-9 
 
 
x 
 
 
x 
  X 
Adverse events 
 
 
 
 
x 
x 
  X 
 
 
 
 
 
 
 
 
CARER QUESTIONNAIRES 
 
 
 
 
 
 
 
SDQ-P 
 
 
x 
 
 
x 
  X 
RCADS-P 
 
 
x 
 
 
x 
  X 
CA-SUS 
 
 
x 
 
 
x 
  X 
Adverse events 
 
 
 
 
x 
x 
  X 
 
 
 
 
 
 
 
 
QUALITATIVE INTERVIEWS 
 
 
 
 
 
 
 
Adolescents 
 
 
 
 
 
x 
 
Carers 
 
 
 
 
 
x 
 
Therapists 
 
 
 
 
 
x 
 
 
 
 

OPTYC case series protocol 
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DAWBA Development and Well-Being Assessment (online assessment) 
CAPS-CA-5, diagnostic interview for PTSD 
CGAS, clinician rated global measure of functioning  
CPSS-5, severity of PTSD symptom (27 items) 
CRIES-8, severity of PTSD (8 items) 
RCADS-C, severity of anxiety and depression (47 items) 
CPTCI, appraisals potential mediator (10 items) 
CHU-9, health state preferences (quality of life) (9 items) 
SDQ-P, emotional and behavioural problems (33 items) 
RCADS-P, severity of anxiety and depression (47 items) 
CA-SUS, service use and costs (50 items) 
 
 

OPTYC case series protocol 
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3. Participants 
Participants will be recruited from CAMHS services in the South London and Maudsley NHS 
Foundation Trust.  
3.1.1 Inclusion criteria assessed at baseline interview 
1. Participant is aged 12-17 years old 
2. Main presenting problem is PTSD and there is a not a co-morbid problem that would 
preclude treatment of PTSD.  
Potential PTSD will be diagnosed using CAPS-CA-5.  The assessment of potential co-
morbid disorders that would preclude treatment of PTSD will be informed by the online 
DAWBA questionnaire (completed online prior to baseline interview) and based on 
clinical judgement at the face-to- face clinical interview. The overall assessment of 
comorbidity will therefore be based on clinical judgement. A standard operating 
procedure (SOP) will be prepared detailing how this clinical assessment should be 
made, to improve reliability across clinicians. 
3. PTSD symptoms related to a single trauma 
4. Participant has access to compatible smartphone and larger computing device (e.g. 
laptop, desktop computer, iPad) with internet access. 
5. Participant is proficient in speaking and writing in the English language, sufficient to 
participate in treatment without an interpreter.  
 
3.1.2 Exclusion criteria assessed at baseline interview 
1. Brain damage assessed by clinical interview with parents / carers 
2. Intellectual disability assessed by clinical interview with parents / carers  
3. Pervasive developmental disorder or neurodevelopmental disorder assessed by clinical 
interview with parents / carers 
4. Other psychiatric diagnosis that requires treatment before PTSD, determined by clinical 
interview and questionnaires 

OPTYC case series protocol 
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5. Moderate to high risk to self assessed in clinical interview 
6. Ongoing trauma-related threat assessed in clinical interview 
7. Started treatment with psychotropic medication, or changed medication, within the last 2 
months, assessed in clinical interview 
8. Currently receiving another psychological treatment, assessed in interview  
9. . Have already received Trauma Focused CBT in relation to the same traumatic event 
that they are currently seeking treatment for. 
4. Analysis 
 Acceptability  
We will carry out qualitative interviews at the end of iCT (approximately 13 weeks after the 
baseline interview).  If participants drop out of treatment early, we will endeavour to interview 
them as well as interviewing participants who complete a full course of treatment.  The views 
and experiences of patients, parents/caregivers, and clinicians will be sought in order to gain a 
multi-perspective view of acceptability. Both commonalities and variations within and between 
these respondents will be explored. We will summarise interview data using content analysis.   
We will report appropriate descriptive statistics for the acceptability ratings of the intervention 
and the questionnaire pack, completed by young people at the end of treatment (e.g. means 
and standard deviations for continuous outcomes; counts and percentages for categorical 
outcomes). 
We will report completion rates for all measures (number and percentage of measures 
completed, out of total number of measures; and percentage of items completed for each 
measure).   
 Adherence 
We will report descriptive summary statistics for the adherence metrics listed above in 2.3.2.   
 Clinical change 
We will report descriptive statistics for all measures at each time point.  We will categorise 
participants based on Reliable Change in Child Post-Traumatic Stress Scale (CPSS-5).  We will 
report the number and proportion of participants who achieve: 
(i) 
Significant improvement of PTSD symptoms at post-treatment, defined as a 
reduction of >= 14 points on this scale; and  

OPTYC case series protocol 
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(ii) 
No significant worsening of PTSD symptom scores at post-treatment, defined as an 
increase of >= 14 points on this scale.  
5. Study procedures 
 Intervention 
All participants will undergo internet Cognitive Therapy for PTSD  (iCT-PTSD) treatment. iCT-
PTSD comprises therapist-supported online delivery of all components from our face-to-face CT 
manual.  
A course of iCT will deliver the same treatment components as face-to-face CT. These include: 
psycho-education about PTSD and its treatment, behavioural activation, developing a narrative 
of the trauma, re-appraisal of trauma-related cognitions, updating the trauma memory, dealing 
with reminders, developing a relapse-prevention blueprint, and working with parents.  
All patients will meet their therapist face-to-face at the baseline assessment. Patients will be 
supported throughout treatment with regular (at least weekly) phone contact with their therapist 
and frequent messaging with their therapist. 
We will make full use of online multi-media to maximise delivery of treatment, including use of 
appealing graphics and animation, videos of young people. Our design and development of the 
inline intervention includes frequent input from and testing with young people and patients. 
 Schedule of treatment for each visit  
Following a face to face baseline assessment, participants will receive iCT over 12 weeks, 
supported by a weekly 15-minute phone call from their therapist. At the end of the 12-week 
treatment period, they will be invited for a post-treatment assessment face to face, and invited to 
take part in a qualitative interview to gauge acceptability of iCT. 
 Informed Consent Procedures 
All recruitment documents, Participant Information Sheets and consent forms will be reviewed 
by the project Young Advisor Group and modified accordingly.   
Participants will be initially approached about the project by a member of their clinical care 
team.  If they appear to be eligible, they will be given Patient Information Sheets to read, and 
their consent obtained to pass their details to the project team.  
The project team will follow up with a phone call to the young person and carer after at least 48 
hours. The study will be explained in detail, and any questions the young person or carer has 
about the study will be answered by a member of the research team.  The Investigator will 
explain to the potential participant that they are free to refuse any involvement within the study 
or alternatively withdraw their consent at any point during the study and for any reason. 

OPTYC case series protocol 
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The researcher will screen for eligibility against inclusion criteria 1 (aged between 12 – 17), 3 
(experience of a traumatic event), and 4 (access to a smart-phone and computer); and 
exclusion criteria 7 and 8 (currently receiving treatment).   
If the young person meets these initial inclusion criteria, consent will be sought. If they choose 
to take part, the young person and carer will be asked to formally record their consent using a 
secure online system.   
After consenting, an appointment will be arranged for a detailed face to face interview, and they 
will be invited to complete an online assessment (DAWBA) of anxiety and depression.  At the 
face to face meeting, participants will be asked to confirm their consent in writing by signing the 
consent form.  If the detailed face to face clinical assessment confirms that they are eligible for 
the study, then they will be offered iCT to start the following week.   
During treatment, if there is any further safety information which may result in significant 
changes in the risk/benefit analysis, the Patient Information Sheet will be reviewed and updated 
accordingly.  All participants who are actively enrolled on the study will be informed of the 
updated information and given a revised copy of the PIS to confirm their wish to continue on the 
study.  
 Risks/burdens 
Participants who take part in the case series may experience some upset while updating their 
trauma memory during therapy. Our experience is that such distress is temporary and support 
will be provided as necessary as part of therapy. 
 
6. Data handling 
 Confidentiality  
Information about study participants will be kept confidential and managed in accordance with 
the Data Protection Act, GDPR policies, NHS Caldicott Guardian, The Research Governance 
Framework for Health and Social Care, and Research Ethics Committee Approval.  
• 
Personally-identifiable information will be collected from participants including name and 
contact details. This information will be stored securely and separately from all other 
study-generated data, which will be pseudo-anonymised (i.e. participants will be 
assigned a study ID). 
• 
The treating clinician and research team involved in day to day trial management will 
have access to personally identifiable data. This is so that they can maintain contact with 
participants throughout the study.  

OPTYC case series protocol 
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• 
The Chief Investigator is the ‘Custodian’ of the data. 
• 
Participant identifiable details will not be transferred outside the EU.  
• 
Participants retain the right to revoke their authorisation for the use of their identifiable 
information. 
• 
Participants will be anonymised with regards to any future publications relating to this 
study. 
 Data collection 
• 
Baseline and interviews will be conducted by unblind members of the study team. 
• 
Post-treatment interviews will be conducted by blinded outcome assessors.  
• 
All clinical assessors will be trained to a standard on the CAPS-CA-5. 
 Case Report Forms 
• 
All interviewers will record participant responses on a paper case report form (CRF). 
• 
The interviewer will then re-enter this information into the electronic database, described 
below. 
• 
Please see Table below for parameters captured by the Case Report Forms, including 
when data is gathered (study time point), how (interview or questionnaire) and by whom 
(research team, treating clinician, or blind assessor).   
Time Point 
CRF# 
Parameter 
Questionnaire 
or Interview 
Responsible 
Person 
Method of 
delivery 
Enrolment 
 
 
 
 
 
1 
Registration 
N/A 
Study RA 
F2F/phone 
 
2 
Eligibility/exclusion screen 
N/A 
Study RA 
F2F/phone 
 
3 
Demographics-C 
N/A 
Study RA 
F2F/phone 
 
4 
Demographics-P 
N/A 
Study RA 
F2F/phone 
 
5 
Consent Form 
N/A 
Study RA 
F2F 
 
6 
Delays Form 
N/A 
Study RA 
N/A 
Baseline 
 
 
 
 
7 
PTSD diagnosis 
CAPS-CA-5 
Clinician 
F2F 
 
8 
Global Functioning 
CGAS 
Clinician 
F2F 
 
9 
PTSD symptoms 
CPSS-5 
Clinician/ 
Study RA 
F2F 

OPTYC case series protocol 
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10 
PTSD symptoms  
CRIES-8 
Clinician/ 
Study RA 
F2F 
 
11 
Anxiety and Depression symptoms 
RCADS-C 
Clinician/ 
Study RA 
F2F 
 
12 
PTSD symptoms 
CPTCI-s 
Clinician/ 
Study RA 
F2F 
 
13 
Quality of Life 
CHU-9D 
Clinician/ 
Study RA 
F2F 
 
14 
Behavioural and Emotional difficulties 
(parent-rated) 
SDQ-P 
Clinician/ 
Study RA 
F2F 
 
15 
Anxiety and Depression symptoms 
(parent-rated) 
RCADS-P 
Clinician/ 
Study RA 
F2F 
 
16 
Use of services 
CA-SUS 
Clinician/ 
Study RA 
F2F 
Weeks 1-12 
 
 
 
 
PTSD symptoms 
CRIES-8 
Clinician 
Online/F2F 
 
Mood rating (0-10) 
N/A 
Clinician 
Online/F2F 
Mid (0+6 
weeks) 
 
 
 
 
17 
PTSD symptoms 
CRIES-8 
Clinician 
Online/F2F 
 
18 
PTSD appraisals 
CPTCI-s 
Clinician 
Online/F2F 
 
19 
Adverse Events-C 
N/A 
Clinician 
F2F/Phone 
 
20 
Adverse Events-P 
N/A 
Clinician 
F2F/Phone 
Post (0+16 
weeks) 
 
 
 
 
21 
PTSD diagnosis 
CAPS-CA-5 
Clinician 
F2F 
 
22 
Global Functioning 
CGAS 
Clinician 
F2F 
 
23 
PTSD symptoms 
CPSS-5 
Clinician/ 
Study RA 
F2F 
 
24 
PTSD symptoms  
CRIES-8 
Clinician/ 
Study RA 
F2F 
 
25 
Anxiety and Depression symptoms 
RCADS-C 
Clinician/ 
Study RA 
F2F 
 
26 
PTSD symptoms 
CPTCI-s 
Clinician/ 
Study RA 
F2F 
 
27 
Quality of Life 
CHU-9 
Clinician/ 
Study RA 
F2F 
 
28 
Adverse Events-C 
N/A 
Clinician/ 
F2F 

OPTYC case series protocol 
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Study RA 
 
29 
Behavioural and Emotional difficulties 
(parent-rated) 
SDQ-P 
Clinician/ 
Study RA 
F2F 
 
30 
Anxiety and Depression symptoms 
(parent-rated) 
RCADS-P 
Clinician/ 
Study RA 
F2F 
 
31 
Use of services 
CA-SUS 
Clinician/ 
Study RA 
F2F 
 
32 
Adverse Events-P 
N/A 
Clinician/ 
Study RA 
F2F 
 
33 
Experience of the intervention and trial 
(YP-rated) 
Qualitative-C 
Study RA 
F2F 
 
34 
Experience of the intervention and trial 
(parent-rated) 
Qualitative-P 
Study RA 
F2F 
 
35 
Experience of the intervention and trial 
(therapist-rated) 
Qualitative-
therapist 
Study RA 
F2F 
Follow up 
(0+10m) 
 
 
 
 
 
36 
PTSD symptoms 
CPSS-5 
Clinician/ 
Study RA 
Online/post/phone 
 
37 
PTSD symptoms  
CRIES-8 
Clinician/ 
Study RA 
Online/post/phone 
 
38 
Anxiety and Depression symptoms 
RCADS-C 
Clinician/ 
Study RA 
Online/post/phone 
 
39 
PTSD symptoms 
CPTCI-s 
Clinician/ 
Study RA 
Online/post/phone 
 
40 
Quality of Life 
CHU-9 
Clinician/ 
Study RA 
Online/post/phone 
 
41 
Adverse Events-C 
N/A 
Clinician/ 
Study RA 
Online/post/phone 
 
42 
Behavioural and Emotional difficulties 
(parent-rated) 
SDQ-P 
Clinician/ 
Study RA 
Online/post/phone 
 
43 
Anxiety and Depression symptoms 
(parent-rated) 
RCADS-P 
Clinician/ 
Study RA 
Online/post/phone 
 
44 
Use of services 
CA-SUS 
Clinician/ 
Study RA 
Online/post/phone 
 
45 
Adverse Events-P 
N/A 
Clinician/ 
Study RA 
Online/post/phone 
 
46 
SAE-child 
N/A 
Clinician/ 
Study RA 
Online/post/phone 

OPTYC case series protocol 
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47 
SAE-parent 
N/A 
Clinician/ 
Study RA 
Online/post/phone 
 
48 
Withdrawal from study 
N/A 
Clinician/ 
Study RA 
Online/post/phone 
 
*Study RA if follow up questionnaire data collected online or by post; Blind assessor if follow up 
questionnaire data collected by phone or in person 
 
 Data storage 
All outcomes will be stored in SPSS databases. These databases will be stored on a secure 
KCL network drive, accessible to the study team only. The study team will provide data extracts 
to the trial statisticians, upon request. 
Data validation will be carried out at the time of data entry (in SPSS) to ensure that entered 
values are valid (e.g. for dates, within an allowed period; for continuous variables, within an 
allowed range; for categorical, within a list of allowed responses). These validity criteria will be 
specified in a database specification document, stored in the trial master file. 
Databases will be stored in a version control system, such that changes made over time can be 
examined and recovered. 
All databases will be registered in the King’s Data Protection Register (KDPR). 
 Record Retention and Archiving 
During the course of the study, all records are the responsibility of the Chief Investigator and will 
be kept in secure conditions in accordance with the King’s College London data security policy. 
The primary data-sets and secondary data analyses will be retained for a minimum of ten years. 
 Compliance 
The PI will ensure that the trial is conducted in compliance with the principles of the Declaration 
of Helsinki (1996), and in accordance with all applicable regulatory requirements including but 
not limited to the Research Governance Framework, Trust and Research Office policies and 
procedures and any subsequent amendments. 
 

OPTYC case series protocol 
21 
 
7. Assessment of Safety 
Procedures for Recording and Reporting Adverse Events 
7.1.1 Definitions 
Adverse Event (AE) 
Any untoward occurrence in a trial participant, including 
events that are not necessarily caused by or related to trial 
procedures. 
Adverse Reaction (AR) 
Any untoward and unintended response in a trial 
participant which is related to trial procedures. 
Unexpected Adverse Reaction 
(UAR) 
An adverse reaction the nature and severity of which is not 
consistent with the information known about the therapy in 
question in the view of the investigator. 
Serious Adverse Event (SAE), 
Serious Adverse Reaction 
(SAR) or Unexpected Serious 
Adverse Reaction (USAR) 
Any adverse event, adverse reaction or unexpected 
adverse reaction, respectively, that: 
• Results in death; 
• Is life-threatening; 
• Required hospitalisation or prolongs existing 
hospitalisation; 
• Results in persistent or significant disability or 
incapacity. 
7.1.2 Types of adverse events  
Adverse Events (AEs) do not require reporting to the REC or sponsors but will be 
reported routinely to the Project Management Group.  
Some AEs are expected and possible within this study population. These include: 
• 
Self-harm not requiring medical attention (e.g. minor scratching) 
• 
Increase in suicidal ideation (assessed by clinical interview) 
• 
Worsening of PTSD symptoms (defined as 7-point increase in CRIES-8) 
AEs may include non-medical events, for example: 
• 
Children’s schooling or carers’ work is adversely affected (e.g. due to time spent in 
therapy or assessments encroaching on school or homework time) 

OPTYC case series protocol 
22 
 
• 
A sustained and significant increase in detrimental behaviours (e.g. safety seeking 
behaviours) as determined by any of the outcome measures collected throughout the 
study 
Serious Adverse Events will be reported to the Independent Chair of the TSC, the 
Research Ethics Committee, and the R&D sponsor 
Serious adverse events (SAE) are defined above. They may represent a worsening of AE 
symptoms. For example: 
• 
Self-harm requiring medical attention e.g. cutting with a blade 
• 
Suicidal behaviours or suicide attempts e.g. overdose of medication 
Contact details for the sponsor are on page 2. Contact details for the Chair of the TSC are 
on page 3.  
 Monitoring of adverse events 
Adverse events will be assessed at each face-to-face assessment time point. Risk monitoring 
including adverse event monitoring will be carried out during clinical contact (approximately 
weekly). AEs will be monitored and recorded from pre-treatment to final follow-up (10-month 
follow-up). 
 Reporting Responsibilities 
• 
Assessors and therapists must report all SAEs to the Chief Investigator first where 
possible. 
• 
All SAEs will be reported to the sponsor and the independent chair of the TSC by the 
Chief Investigator within 7 days.  
• 
All SARs and USARs will be reported by the Chief Investigator to the Research Ethics 
Committee, using the NRES template, within 15 days of the CI becoming aware of the 
event. 
• 
The Coordinator of the main REC will acknowledge receipt of safety reports within 30 
days.  
• 
A copy of the SAE notification and REC acknowledgement receipt will be copied to the 
sponsor.   
• 
All AEs will be reported in the Annual Progress Report to the ethics committee and 
copied to the sponsor. 
• 
All AEs and SAEs will be recorded and reported in the trial report. 
 

OPTYC case series protocol 
23 
 
 Stopping Rules 
The case series may be prematurely discontinued by the Sponsor or Chief Investigator based 
on new safety information or for other reasons given by the Ethics Committee, Trial Steering 
Committee or other regulatory authority concerned. 
The case series may also be discontinued due to lack of recruitment or upon advice from the 
Trial Steering Committee, who will advise on whether to continue or discontinue the study and 
make a recommendation to the sponsor. If the study is prematurely discontinued, active 
participants will be informed. In consultation with the Independent Chair, next steps will be 
agreed upon. It is most likely that data collection would continue but that participants would no 
longer receive the intervention. 
 
8. Study oversight arrangements 
 Project Management Group 
Project oversight will be provided by a Project Management Group (PMG). The PMG is 
chaired by the PI and attended by all CIs. The PMG will meet monthly and is responsible for all 
aspects of project management including: 
• 
Monitoring the delivery of the scientific results needed to progress the project 
• 
Monitoring the project against budget/schedule 
• 
Monitoring the project against agreed milestones and identification of risks to achieving 
milestones as well as solutions for managing risks and issues resolution 
• 
Providing access to appropriate resources necessary for project progression, including 
internal and outsourced resources and the management of these resources 
• 
Identification and capture of project generated intellectual property (IP) and the 
development of a protection and exploitation strategy 
• 
Development of requests for change to the plan if milestones are at risk 
 Trial Steering Committee 
Study oversight will be provided by a Trial Steering Committee (TSC).  
We have convened a TSC at this stage in preparation for the planned feasibility RCT. We will be 
submitting a separate application for ethical approval to proceed to a feasibility RCT.   

OPTYC case series protocol 
24 
 
The role of the TSC will be to review and agree this protocol, to agree the analysis plan, and to 
safeguard the interests of trial participants. 
The independent members of the TSC will be independent from the sponsor and funder. 
The membership, responsibilities, frequency of meetings, activity (including trial conduct and 
data review) and authority will be described in the TSC Charter. The Charter will be prepared 
and signed off by all committee members shortly after the second TSC meeting. 
The first TSC was held in October 2018 (to give advice on this protocol and REC applications). 
The second is planned for Summer 2019 (after the case series). Subsequent TSC meetings are 
planned for January 2020 (6 months after trial recruitment has started) and September 2020 (to 
monitor trial recruitment and implementation). 
 Protocol amendments 
Protocol amendments will be discussed and approved by TSC. They will be reported in 
subsequent TSC closed reports (i.e. to be prepared by the unblinded trial statistician and seen 
only by TSC members, not by study team members, including the blinded senior statistician). 
Any approved amendments will be submitted to the REC for approval, and to the sponsor. 
9. Ethics & Regulatory Approvals 
The CI will ensure that REC Favourable Opinion, HRA approval, and Trust Confirmation of 
Capacity and Capability will be in place before recruiting from the Trust.  Should it be necessary 
to add research sites at a later stage, the sponsor will be approached to review an amendment 
for submission to the HRA, and Confirmation of Capacity and Capability will be obtained from 
the new NHS sites before starting recruitment from research sites. 
  
Amendments  
The CI is aware that all amendments must be notified to the sponsor, and agreement from the 
study sponsor is required before an amendment is submitted to the REC/HRA. The CI will check 
the detailed guidance on amendments on the HRA website beforehand to familiarise himself 
with the process: http://www.hra.nhs.uk/research-community/during-your-research-
project/amendments/ 
10. Finances 
This project is being carried out with funding awarded from the MRC DPFS scheme (Total FEC 
£1.3m). King’s College London receives and manages the funding on behalf of all sites and 
collaborating institutions. 

OPTYC case series protocol 
25 
 
11. Dissemination policy 
The main findings of the case series will be communicated to participants via an adolescent-
friendly newsletter. 
A report will be prepared for the sponsor and funders. 
We plan to publish a peer-reviewed paper reporting iCT development and findings from the 
case series. 
 
 

OPTYC case series protocol 
26 
 
12. Appendix 1: Information with regards to Safety Reporting 
in Non-CTIMP Research 
 
Who 
When 
How 
To Whom 
SAE 
Chief 
Investigator 
Within 15 days of CI 
becoming aware of the 
event 
 
SAE Report form for Non-
CTIMPs, available from 
NRES website. 
Main REC with a 
copy to the sponsor 
Urgent Safety 
Measures  
Chief 
Investigator  
Immediately 
 
Within 3 days  
By phone 
 
Notice in writing setting 
out reasons for the urgent 
safety measures and the 
plan for future action. 
Main REC  
 
Main REC with a 
copy sent to the 
sponsor. The MREC 
will acknowledge 
this within 30 days of 
receipt.  
Progress 
Reports  
Chief 
Investigator  
Annually ( starting 12 
months after the date 
of favourable opinion) 
Annual Progress Report 
Form (non-CTIMPs) 
available from the NRES 
website 
Main REC with a 
copy to the sponsor 
Declaration of 
the conclusion 
or early 
termination of 
the study 
Chief 
Investigator  
Within 90 days 
(conclusion) 
 
Within 15 days (early 
termination) 
 
The end of study 
should be defined in 
the protocol 
End of Study Declaration 
form available from the 
NRES website 
Main REC with a 
copy to the sponsor  
Summary of 
final Report  
Chief 
Investigator 
Within one year of 
conclusion of the 
Research 
No Standard Format 
However, the following 
Information should be 
included:- 
Main REC with a 
copy to be sent to 
the sponsor 

OPTYC case series protocol 
27 
 
Where the study has met 
its objectives, the main 
findings and 
arrangements for 
publication or 
dissemination including 
feedback to subjects