Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon: Phase II
Phase: NA
Conditions: Depression, Anxiety, PTSD, Conduct Disorder, Oppositional Defiant Disorder
Sponsor: Queen Mary University of London

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 1 of 35 
 
 
 
 
 
 
JRMO Non-CTIMP Protocol Template 
 
 
 
 
 
 
1. TITLE PAGE 
 
Full Title  
Development, Piloting and Evaluation of a 
Phone-Delivered Psychological Intervention (t-
CETA) for Syrian Refugee Children in Lebanon: 
Phase II 
 
Short Title/Acronym  
 
t-CETA 
 
Sponsor 
  
Name the sponsor organisation and contact 
person:  
 
Queen Mary University of London  
 
Contact 
person 
of 
the 
above 
sponsor 
organisations is: 
 
 
 
Dr. Mays Jawad 
R&D Governance Operations Manager 
Joint Research Management Office 
 
5 Walden Street 
 
London 
 
E1 2EF 
 
Phone: 020 7882 7260 
 
Email: research.governance@qmul.ac.uk 
 
 
REC Reference 
SBS-2018-0582 (IRB of American University of 
Beirut, Lebanon).  
 
 
Chief Investigator 
Prof. Michael Pluess 
Reader in Developmental Psychology 
Head of Department 
Biological and Experimental Psychology 
School of Biological and Chemical Science 
Queen Mary University of London 
Mile End Road 
London E1 4NS 
Phone 0207882 8004 
Email: m.pluess@qmul.ac.uk  
 
Local Principle Investigator 
Dr. Tania Bosqui  
Assistant Professor in Clinical Psychology 
American University of Beirut 
P.O.Box 11-0236 
Department of Psychology 
Riad El-Solh / Beirut 1107 2020 

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 2 of 35 
 
 
 
 
 
Lebanon 
Phone +961 1 350 000 ext: 4370 
Email: tb33@aub.edu.lb  
 
Study Team 
 
 
PI Prof. Michael Pluess, Reader in Developmental Psychology at Queen Mary 
University of London, UK 
 
Study coordinator (London) Dr. Fiona McEwen, Postdoctoral Researcher at 
Queen Mary University of London, UK.  
 
Field work coordinator (Lebanon) Ms Patricia Moghames, Médecins du 
Monde, Lebanon 
 
Trial coordinator (Lebanon) Mr Nicolas Chéhadé (TBC), Médecins du 
Monde, Lebanon 
 
Co-I (acting as local PI in Lebanon) Dr Tania Bosqui, Assistant Professor in 
Clinical Psychology at American University of Beirut, Lebanon 
 
Advisor Dr Alaa Hijazi, Assistant Professor in Clinical Psychology at 
American University of Beirut, Lebanon 
 
Co-I Dr Laura Murray, Clinical Psychologist at Johns Hopkins Bloomberg 
School of Public Health, US  
 
CETA trainer and supervisor Stephanie Skavenski, Research Associate at 
Johns Hopkins Bloomberg School of Public Health, US 
 
Co-I Dr Paul Bolton, Senior Scientist at Johns Hopkins Bloomberg School of 
Public Health, US 
 
Co-I Prof. Roland Weierstall, Professor of Clinical Psychology and 
Psychotherapy at Hamburg Medical School, Germany 
 
Co-I Stéphanie Legoff, General Coordinator Lebanon at Médecins du Monde, 
Lebanon 
 
Co-I Zeina Hassan, Regional Mental Health Coordinator at Médecins du 
Monde, Lebanon  
 
Insert as applicable list of  
A) Sites 
a. Queen Mary University of London 
b. Médecins du Monde, Lebanon 
c. American University of Beirut, 
Lebanon 
d. Johns Hopkins Bloomberg School of 
Public Health, US 
e. Hamburg Medical School, Germany 
B) Laboratories and/or technical departments: 
N/A 
C) Central facilities: N/A 
 
 
  
 

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
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Contents Page 
 
 
 
2. 
GLOSSARY OF TERMS AND ABBREVIATIONS  
3. 
SIGNATURE PAGE 
4. 
SUMMARY/SYNOPSIS  
5. 
INTRODUCTION 
6. 
TRIAL OBJECTIVES  
7. 
METHODOLOGY  
Inclusion Criteria 
Exclusion Criteria  
Study Design / Plan – Study Visits  
Study Scheme Diagram 
8. 
STUDY PROCEDURES 
Schedule of Assessment (in Diagrammatic Format) 
End of Study Definition  
9. 
STATISTICAL CONSIDERATIONS (if applicable) 
10. 
ETHICS 
11. 
SAFETY CONSIDERATIONS (if applicable) 
12. 
DATA HANDLING AND RECORD KEEPING  
Confidentiality  
Record Retention and Archiving 
13. 
LABORATORIES (if applicable) 
14. 
PRODUCTS, DEVICES, TECHNIQUES AND TOOLS (if applicable) 
15. 
SAFETY REPORTING (if applicable) 
16. 
MONITORING &AUDITING (if applicable) 
17. 
TRIAL COMMITTEES 
18. 
FINANCE AND FUNDING  
19. 
INDEMNITY  
20. 
DISSEMINATION OF RESEARCH FINDINGS (if applicable) 
21. 
REFERENCES 
22. 
APPENDICES 

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 4 of 35 
 
 
 
 
 
 
2. GLOSSARY  of Terms and Abbreviations 
 
 
AE 
 
 
Adverse Event 
 
 
AR 
 
 
Adverse Reaction 
ASR 
 
 
Annual Safety Report 
CA 
 
 
Competent Authority 
CI 
 
 
Chief Investigator 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organisation 
DMC  
 
Data Monitoring Committee 
EC 
 
 
European Commission 
GAfREC 
Governance Arrangements for NHS Research Ethics 
Committees 
ICF 
 
 
Informed Consent Form 
JRMO  
 
Joint Research Management Office 
NHS REC 
 
National Health Service Research Ethics Committee 
NHS R&D 
 
National Health Service Research & Development   
Participant 
 
An individual who takes part in a clinical trial 
PI 
 
 
Principal Investigator 
PIS 
 
 
Participant Information Sheet  
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
RCT 
 
 
Randomised Controlled Trial 
REC 
 
 
Research Ethics Committee 
SAE 
 
 
Serious Adverse Event 
SDV 
 
 
Source Document Verification 
SOP 
 
 
Standard Operating Procedure  
SSA 
 
 
Site Specific Assessment 
TMG  
 
Trial Management Group 
TSC 
 
 
Trial Steering Committee 
 
 
 
 
 
 
 

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 5 of 35 
 
 
 
 
 
 
 
 
3. SIGNATURE PAGE 
 
 
Chief Investigator Agreement 
 
 
The clinical study as detailed within this research protocol (Version 2.3, dated 23rd 
April 2019), or any subsequent amendments will be conducted in accordance with 
the Research Governance Framework for Health & Social Care (2005), the World 
Medical Association Declaration of Helsinki (1996) and the current applicable 
regulatory requirements and any subsequent amendments of the appropriate 
regulations. 
 
Chief Investigator Name: Michael Pluess 
Chief Investigator Site: Queen Mary University of London 
Signature and Date: 23/04/2019  
 
 
 
 
 
 
Principal Investigator Agreement (if different from Chief investigator) 
 
 
The clinical study as detailed within this research protocol (Version 2.3, dated 23rd 
April 2019), or any subsequent amendments will be conducted in accordance with 
the Research Governance Framework for Health & Social Care (2005), the World 
Medical Association Declaration of Helsinki (1996) and the current applicable 
regulatory requirements and any subsequent amendments of the appropriate 
regulations. 
 
Principal Investigator Name: Tania Bosqui 
Principal Investigator Site: American University of Beirut 
Signature and Date: 23/04/2019  
 

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 6 of 35 
 
 
 
 
 
4.    SUMMARY/SYNOPSIS 
 
 
Short Title 
t-CETA 
 
Methodology 
 
This study involves the development, piloting and 
evaluation of a phone delivered intervention (t-CETA) in 
Syrian refugee children in Lebanon. An existing treatment, 
Common Elements Treatment Approach (CETA), will be 
culturally adapted for Syrian refugees and adapted for 
phone delivery. It will then be evaluated using a 
randomised controlled trial, comparing t-CETA to 
treatment as usual.  
 
The study will be carried out in Lebanon with 200 Syrian 
children, aged 8-17 years, who were displaced by the war 
in Syria. In Phase I up to 60 children will participate in 
face-to-face CETA and this will be used to adapt CETA for 
telephone administration (t-CETA). t-CETA will be piloted 
in 10-20 children and qualitative interviews used to 
determine acceptability and feasibility. In Phase II up to 
120 children will be randomised to receive t-CETA or 
treatment-as-usual (standard treatment provided by 
Médecins du Monde). Both children and primary 
caregivers will be interviewed to assess the child’s mental 
health, including measures of psychopathology (anxiety, 
depression, PTSD, and externalising behaviour problems) 
and wellbeing. Independent assessment will be conducted 
at baseline (pre-intervention assessment), immediately 
after treatment, and at 3 month follow up. t-CETA will be 
delivered in weekly or twice weekly sessions of 30-60 
minutes over the span of 8-16 weeks.  
 
The proposed interdisciplinary project includes research 
groups in the UK, Lebanon, US, and Germany. 
 
Research Sites 
 
 
Queen Mary University of London 
 
Médecins du Monde, Lebanon   
 
American University of Beirut, Lebanon 
 
Johns Hopkins University, US 
 
Hamburg Medical School, Germany 
Objectives/Aims 
 
 
Objective 1: Development of telephone-delivered 
CETA (t-CETA) by adapting the existing face-to face 
CETA intervention (completed during Phase I; IRB 
approval on 8th November 2017: FAS.TB.06/SBS-
2017-0429) 
 
Objective 2: Scientific evaluation of the effectiveness 
of t-CETA with a pilot randomised controlled trial. 
Number of 
120 Syrian children and their primary caregiver  

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 7 of 35 
 
 
 
 
 
Participants/Patients 
 
Main Inclusion Criteria 
 
Lebanon-based Syrian refugee children of Arabic ethnicity 
aged 8-17 years and scoring above threshold on standard 
measures of psychopathology 
 
Statistical 
Methodology and 
Analysis (if applicable) 
 
Randomised controlled trial: comparison of t-CETA to 
treatment as usual on key outcome measures.  
Please see section on statistical analyses for more 
details. 
 
Proposed Start Date 
Funded from1st September 2017 
 
Phase I 
- 
recruitment from May 2018 
Phase II 
- 
recruitment from April 2019 
 
Proposed End Date 
Funded period: 1st September 2019 
Study end (including no-cost extension): 1st  March 2020 
 
Study Duration 
 
Funded period: 2 years 
Including no-cost extension: 2.5 years 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 8 of 35 
 
 
 
 
 
5. INTRODUCTION  
Current State: There are currently more than 2 million internationally displaced 
Syrian refugee children in countries surrounding Syria, with more than 500,000 living 
in Lebanon [1]. In addition to the ongoing conflict in Syria, every year millions of 
children from other countries are faced with the severe consequences associated 
with war and political conflict [2]. Empirical studies confirm that refugee children are 
at great risk of developing psychological problems, including post-traumatic stress 
disorder, depression and behavioural problems [3, 4]. The few studies on mental 
health of Syrian refugee children suggest that about 45% of surveyed Syrian refugee 
children in Turkey meet criteria for PTSD and about 20% present with clinical 
depression [5].  
 
The significant need for psychological treatment among Syrian refugee 
children stands in stark contrast to the limited availability of services in most low and 
middle income host countries. Lebanon, for example, already suffered from a 
shortage of mental health services before the Syria crisis [6]. The total number of 
specialised mental health professionals working with refugees in Lebanon is 
extremely low with about 7-9 psychiatrists and 30-40 psychologists for a refugee 
population of more than 1 million [7]. In addition, access to services is very 
challenging for many refugees due to high mobility, cultural factors (e.g., stigma of 
mental illness) as well as living far away from mental health services (i.e., 
transportation costs). 
 
Research Gap: While there is an overwhelming need for the psychological treatment 
of refugee children, available mental health services, particularly those specialised 
for children, are often insufficient and very difficult to access for the refugee 
population. These challenges are not unique to Lebanon and the Syria crises. 
Organisations aiming at improving mental health in low and middle income countries 
tend to be confronted with at least three significant obstacles: 
 
1. Lack of funding to cover the high costs of setting up new mental health 
services 
2. Difficulty in recruiting local qualified mental health professionals 
3. Restricted access of refugee population to primary health care centres 
 
These challenges are very difficult to address with conventional mental health 
services, which tend to be provided by mental health specialists in centralised 
primary health care centres [7]. However, over the last years access to mobile phone 
technology has improved across the globe and even people in remote areas with 
very limited resources have access to mobile phones which opens up a new and 
innovative avenue to overcome the three listed obstacles: The provision of mental 
health and psychological support services over the phone with the help of 
trained lay counsellors. Recent studies provide empirical evidence that cognitive 
behavioural therapy can be administered effectively over the phone in Western 
countries [8, 9]. Furthermore, transdiagnostic interventions delivered by trained non-
specialists have been shown to be effective in the treatment of various psychological 
problems [10, 11]. What has not been tested yet, is whether trained local non-
specialists can deliver effective psychological treatment over the phone in an 
emergency setting in low and middle income countries.  
 
Impact: The proposed study focuses on the development of a new innovative 
approach for the delivery of effective mental health treatment to children in low 
resourced settings. Delivery of psychological services over the phone will improve 

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 9 of 35 
 
 
 
 
 
health results by making psychological intervention much more accessible at a 
significantly reduced cost compared to current standard approaches. Children are the 
most vulnerable victims of war and displacement. However, psychological treatment 
for traumatised children is often not easily accessible and generally provided in group 
settings that don’t allow addressing individual needs [7]. Although most people in 
emergency settings have access to mobile phones, this technology has not yet been 
utilised for the delivery of mental health and psychosocial support. The proposed 
study is the first to explore this promising possibility in emergency settings and will 
provide important empirical findings regarding the feasibility and efficacy of 
telephone-administered psychological treatment delivered by trained local non-
specialists who are familiar with both language and culture of the refugee population. 
The Common Element Treatment Approach (CETA) utilises the most effective CBT 
components. After identifying the most relevant CETA components through face-to-
face delivered CETA among Syrian refugees in the Beqaa valley, these 
psychotherapy elements will be adapted for the use over phone and tested in a 
randomised controlled trial. Our study will yield the following specific results: 
 
1. Identification of the most relevant CETA components for Syrian refugee 
children  
2. Manual and training material for telephone-delivered CETA (t-CETA)   
3. Detailed protocols to ensure child protection, safety and privacy 
4. Empirical data on the efficacy of t-CETA based on a randomised controlled 
trial 
5. Information on acceptance and implementation of t-CETA  
 
Long Term Impact: If found to be successful, telephone-administered psychological 
treatment (t-CETA) will provide an innovative, promising, highly economical and 
widely scalable alternative approach for the provision of mental health and 
psychological support services in emergency situations. Importantly, this approach 
can easily be applied to other and future settings where children have experienced 
trauma and therefore represents a new and important addition to the tool box of 
humanitarian organisations and agencies faced with the challenge of providing 
mental health services in under-resourced emergency settings. Importantly, we plan 
to test t-CETA in large multinational follow-up studies and to develop a global 
network of t-CETA training- and supervision centres. 
 
Improving Health results: The newly developed treatment approach will 
improve mental health in the long-term by providing access to those that are not 
able to receive psychological treatment due to a lack of such services in the first 
place or constrained access to them (i.e., long distance from primary health care 
centres, lack of transport, mental health stigma etc.). 
 
Cost-effectiveness: Given that t-CETA does not require local facilities and mental 
health professionals, it can be delivered more easily, more quickly and at lower cost 
than traditional mental health services which are centre based and delivered by 
professionals. This will also enable non-medical humanitarian organisations to offer t-
CETA (in collaboration with medical organisations who are able to provide the 
required training and supervision). 
 

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 10 of 35 
 
 
 
 
 
6. TRIAL OBJECTIVES 
The proposed study is an international collaboration between Queen Mary University 
of London (UK), Médecins du Monde (Lebanon), Johns Hopkins University (USA), 
American University of Beirut (Lebanon) and Medical School Hamburg (Germany) 
with the aim to adapt an existing effective transdiagnostic psychological intervention 
for children, Common Elements Treatment Approach (CETA), to the delivery over 
phone to Syrian refugee children in Lebanon by trained and supervised lay 
counsellors. The project has two specific objectives: 
 
1. Development of telephone-delivered CETA (t-CETA) by adapting the 
scientifically validated face-to face CETA programme (including manual 
and detailed training material). This was completed during Phase I. 
2. Scientific evaluation of the effectiveness of t-CETA applying a randomised 
controlled clinical trial. This will be completed during Phase II.  
 
 
7. METHODOLOGY  
Inclusion Criteria  
 
1. Age 8-17 years, male or female 
2. Live with a parent or other legal guardian 
3. Child and/or parent identifies that the child has mental health difficulties 
and requests services 
4. High risk of having mental disorder as indexed by A 
a. Falling in the top 40% of the distribution in any one of the 
following child-report questionnaires: 
1. Screen for Child Anxiety Related Emotional Disorders 
(SCARED) 
2. Center for Epidemiological Studies Depression Scale 
for Children (CES-DC)  
3. Child PTSD Symptom Scale (CPSS)  
b. AND falling in the top 40% of the distribution in the following 
parent-report questionnaire:  
4. Strengths and Difficulties Questionnaire (SDQ) total 
difficulties  
5. Confirmation of significant level of symptoms and functional impairment 
on clinical interview (MINI KID) as indicated by both of:  
a. Meeting full or probable diagnostic criteria for any category of 
mood disorder, any category of anxiety disorder, PTSD, conduct 
disorder, or oppositional defiant disorder 
b. Clinical Global Impression severity (CGI-s) score of >3  
6. Parent/legal guardian gives informed consent and child gives assent to 
take part 
 
A Criterion 4 only applicable to children for whom these data are available 
from participation in the BIOPATH study; Criterion 5 takes precedence over 
Criterion 4 where both are available 
 
Exclusion Criteria  
 

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 11 of 35 
 
 
 
 
 
1. Problem for which t-CETA would not be appropriate, including 
psychiatric disorders for which CETA treatment is not recommended 
(e.g., bipolar disorder, psychosis), severe distress (e.g., acute suicidal 
ideation), or problems that would preclude delivery over telephone (e.g., 
selective mutism)   
2. Parent or legal guardian is not able to provide consent 
3. Child protection issues (e.g., acute maltreatment) that are judged by 
clinician to make trial inclusion inappropriate 
4. Any inclusion criteria not met 
 
Methodological Approach 
In order to test telephone-administered psychological intervention using an adapted 
version of Common Elements Treatment Approach (CETA), we will apply a mixed 
methods approach throughout the project: Quantitative methods will be used in the 
form of a randomised controlled trial to investigate efficacy of the intervention and 
qualitative (in addition to quantitative) methods will be applied in order to explore 
implementation and acceptance of the phone-delivered treatment from the 
perspective of both patients and providers. 
 
Study Design / Plan – Study Visits  
 
Design: The study will be conducted in Lebanon in two stages. In the first stage 
CETA was adapted for phone delivery (completed as Phase I). During Phase II the 
intervention will be tested in a randomised controlled trial. 
 
Development Stage (Phase I; granted IRB approval on 8th November 2017, ref: 
FAS.TB.06/SBS-2017-0429): In order to adapt the existing CETA treatment for 
delivery over the phone, we first treated Syrian refugee children in the Beqaa valley 
with original face-to-face CETA. Local staff in Lebanon were trained and supervised 
by CETA expert Dr Murray and her team. Applying face-to-face CETA on an 
individual basis provides important insights regarding the mental health needs of 
these children and informed the team regarding which of the different CETA 
components are of particular relevance in this specific context. During this period, the 
local team and the CETA experts (Dr Murray and Ms Skavenski) regularly convened 
over skype to discuss which of the CETA components could be delivered in a 
culturally sensitive way without face-to-face contact and to develop a first written draft 
for each CETA component, in collaboration with our clinical experts Drs Bosqui, 
Hijazi and Weierstall. The complete draft of telephone administered CETA (t-CETA) 
is being tested over the phone with a small number of children (10-20 children) and 
continually adapted in close collaboration with all members of the local and 
international research team. As part of this developmental stage, qualitative data (i.e. 
individual interviews with treated Syrian refugee children, their primary caregivers as 
well as mental health staff) are being used to identify potential child protection, safety 
and privacy issues related to telephone-administered treatment. This is informing the 
development of detailed protocols to ensure children’s safety at all times. These 
protocols form a crucial part of the t-CETA manual and training material. The end 
product is a detailed t-CETA manual and training material for non-specialist lay 
providers.  
 
Piloting Stage (Phase II; for review by AUB IRB): The implementation and efficacy 
of t-CETA will be tested with a randomised controlled clinical trial. Up to 120 Syrian 
refugee children will be randomly allocated to either t-CETA or treatment as usual 
provided by Médecins du Monde in primary healthcare centres in the Beqaa valley. 

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 12 of 35 
 
 
 
 
 
When lack of access to a clinic would preclude inclusion in the study (i.e., 
randomisation is not possible in case the family are allocated to treatment as usual, 
which involves attending a Primary Healthcare Centre), families will be offered the 
option of receiving t-CETA only (non-randomised). Data from this non-randomised t-
CETA group will not be included in the RCT but will provide additional, ecologically 
valid data about implementation and efficacy. Data from the original face-to-face 
delivery collected during the developmental stage may be used for comparison, 
providing that there have not been significant changes to the protocol from Phase I to 
Phase II that would make comparison illegitimate. In addition to questionnaires, 
clinical interviews with children and primary caregivers will be conducted before the 
intervention to determine suitability for inclusion. Inclusion and exclusion criteria are 
identical to those used during Phase I, with the exception that questionnaire data will 
not be considered where children are recruited from sources other than the 
BIOPATH study (clinical interview data will take precedence in all cases). 
Assessments will be carried out before and after the intervention as well as during a 
3-month follow-up assessment by independent trained enumerators blind to study 
condition. Implementation and acceptance of the intervention will be further assessed 
with a qualitative study based on interviews with a subset of involved Syrian refugee 
children, their caregivers as well as mental health staff. 
 
Figure 1. Study Scheme Diagram  
 
Face-to-face CETA
Preliminary testing of t-CETA 
with 20 children
Develop t-CETA manual
Finalise t-CETA manual and 
training materials
Year 2
Recruit and train staff
Year 1
Analysis and write up of data
Publication of 
manual and report
Workshops
Pilot RCT of t-CETA
 
 
 
8. STUDY PROCEDURES   
Sample: Children included in the proposed study will be selected from the large 
sample of a NICHD funded study on the biological pathways of risk and resilience in 
Syrian refugee children based in Lebanon headed by PI Prof Pluess and co-PI Dr 
Elie Karam (Biological Pathways of Risk and Resilience in Syrian Refugee Children 
[BIOPATH]; Sponsor: Queen Mary University of London [ReDA Ref: 011120]; Ethical 
approval: Institutional Review Board of the University of Balamand, Lebanon [Ref: 
IRB/O/024-16/1815] and Ministry of Public Health in Lebanon, in consultation with the 
Lebanese National Consultative Committee on Ethics). BIOPATH is a longitudinal 
study and includes 1,600 Syrian refugee families in the Beqaa valley. For each of 
these children we will already have data on a range of psychological outcomes (i.e., 
PTSD, depression, anxiety, behavioural problems; see Table 2 below). From the 
1,600 children, we will select up to 60 based on various psychological symptoms 

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 13 of 35 
 
 
 
 
 
assessed routinely as part of the BIOPATH study at the first BIOPATH data collection 
(approximately October 2017-January 2018) and up to 120 children during the 
second BIOPATH data collection (approximately October 2018-January 2019).  
 
If insufficient numbers of children from the BIOPATH study are recruited using the 
above approach, the following additional approaches will be used: (i) children from 
BIOPATH who take part in the linked VaST study (which involves completing the 
MINI KID clinical interview) will be approached if they meet inclusion criteria and are 
interested in accessing mental health services; (ii) other children in the families who 
took part in BIOPATH (e.g., siblings and cousins) and for whom families requested 
mental health services will be approached; (iii) referrals will be accepted from other 
agencies; (iv) information sessions will be conducted in the community (e.g., in ITS or 
PHCs) to inform families about the research and allow them to request mental health 
assessment for their child(ren); (v) families in contact with participating families will 
be able to contact the study for information and to request mental health assessment 
for their child (snowballing approach).  
 
Primary caregivers will be contacted over the phone and offered clinical assessment 
for their child at no cost, as part of routine clinical care. Families will be invited to 
attend an appointment at an MdM clinic for this assessment. During Phase II, families 
who attend the appointment will first undertake a brief interview to establish what the 
presenting problem is. Following this and providing children do not meet exclusion 
criteria, they will be offered inclusion in the t-CETA study. Those who do not want to 
participate in research, or who clearly meet exclusion criteria, will be offered a 
standard clinical intake assessment and treatment as usual provided by Médecins du 
Monde. Those who do want to participate in research will complete the informed 
consent process and a clinical interview (MINI KID) will then be used to determine 
whether children meet inclusion criteria; if the MINI KID has already been completed 
(e.g., as part of the VaST study) then it will not be repeated, but consent will be 
sought to use these data for the t-CETA study. Those who do not meet inclusion 
criteria or whose difficulties are not appropriate for CETA will be offered treatment as 
usual by Médecins du Monde or referral to another agency, as appropriate. Please 
see t-CETA recruitment flowchart v2.1 for the routes into research or standard clinical 
care. Based on the most recent studies, it is expected that approximately 20-30% of 
the BIOPATH sample will suffer from clinical levels of psychological problems [5]. If 
insufficient numbers of children are recruited from the BIOPATH study then eligible 
children may be recruited through advertisement in the Primary Healthcare Centres 
that service refugee populations in the Bekaa Valley.    
 
Recruitment: Children participating in BIOPATH will be screened and assessed to 
see if they meet inclusion criteria for this study. Evidence of high risk of mental 
disorder will be operationalized in the following way:  
 
1. Child or parent reports during interview for the BIOPATH study that the child 
has a need for mental health services  
AND  
2. Child exceeds a specified cut-off (highest 40% of the distribution) on any of 
the following child-report questionnaires completed during BIOPATH:  
a. Screen for Child Anxiety Related Emotional Disorders (SCARED) 
b. Center for Epidemiological Studies Depression Scale for Children 
(CES-DC)  
c. Child PTSD Symptom Scale (CPSS)  

Project: 012344 
Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
Page 14 of 35 
 
 
 
 
 
AND  
3. Child exceeds a specified cut-off (highest 40% of the distribution) on the 
following parent-report questionnaire completed during BIOPATH:  
a. Strengths and Difficulties Questionnaire (SDQ) total difficulties 
AND  
4. Child meets definite or probable diagnostic criteria for any mood or anxiety 
disorder, PTSD, conduct disorder, or oppositional defiant disorder (assessed 
using MINI KID 6.0; interviewers will gather additional information sufficient to 
assign diagnosis according to DSM-5) 
AND 
5. Clinical Global Impression-severity (CGI-s) score >3 
 
 
[see Table 2 for all measures] 
 
Children who have not participated in BIOPATH will not have questionnaire data to 
review. In these cases, request for mental health services and meeting criteria 4 and 
5 will be sufficient. In all cases, criteria 4 and 5 take precedence over questionnaire 
data.  
 
Caregivers will be contacted over the phone by the t-CETA team to establish if they 
are interested in their child having an assessment, and an appointment with a t-
CETA team member or other MdM case manager/psychotherapist at the MdM CETA 
centre or a Primary Healthcare Centre (PHC) (or in rare cases, in the family’s home) 
will be arranged. This appointment will be offered as part of routine clinical care to 
ensure that all families can access an assessment, regardless of interest in research. 
At this appointment the child and parent will undergo a brief MdM intake interview. If 
the child has a problem that would make CETA inappropriate (e.g., acute suicidal 
ideation, acute child maltreatment) then an emergency procedure will be followed to 
arrange referral to an appropriate agency or hospital. If no such problems are 
disclosed, then inclusion in the t-CETA study will be offered. The study will be 
explained and the informed consent procedure followed. If they wish to take part, the 
parent will provide written consent and the child written assent for study participation. 
If any participant is unable to provide a signature then they will be given the option to 
provide oral consent in lieu of a signature (in the presence of a witness who is 
independent of the research team). If they do not wish to take part, then they will be 
offered standard MdM treatment.  
For families who consent/assent to the study, a clinical interview (MINI KID) will then 
be conducted to establish if the child has difficulties that are suitable for treatment 
using CETA (definite or probable diagnosis of any mood disorder, any anxiety 
disorder, PTSD, conduct disorder, or oppositional defiant disorder). Following the 
MINI KID, if their child does not meet inclusion criteria, or meets exclusion criteria 
such as having difficulties that are not appropriate for CETA (e.g., bipolar disorder, 
schizophrenia) then they will be offered treatment as usual through Médecins du 
Monde or referral to another agency.  
Families who agree to participate will be prepared for subsequent assessments at 
this or another appointment: they will be given a booklet that contains information 
about the assessments, visual aids to support the response format of questionnaires, 
and emergency contact numbers. The assessments will be explained in detail, both 
caregiver and child will complete practice questions, and there will be time for 
discussion to ensure that they understand and are able to complete assessments.  

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Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
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Version 2.3, 23.04.2019, t-CETA 
 
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See Figure 2 and t-CETA recruitment flowchart v2.1 for pathways from referral 
through treatment.  
 
Procedure: Once informed consent and child assent have been gained, a trained 
assessor (not involved in providing treatment) blind to treatment condition (in Phase 
II) will conduct the baseline (pre-intervention) assessment, over the phone (or face-
to-face if phone assessment is not possible), which will take approximately 30 
minutes per child and 30 minutes per caregiver. The assessment includes 
standardized questionnaires and interview questions about the child’s symptoms and 
adaptive functioning. Participants will use the visual aids in the booklet provided to 
help them respond to questions. Data will be collected with the help of tablet or 
laptop computers running Qualtrics and will be uploaded to a secure server. 
Participants will only be identified using an ID on Qualtrics; identifying details will not 
be entered. The assessment process will be supervised by a qualified clinical 
psychologist (Dr Tania Bosqui).  
The schedule of assessments for different conditions is set out in Table 1.  
Phase I (granted IRB approval on 8th November 2017, ref: FAS.TB.06/SBS-2017-
0429): N=~60 children undergo face-to-face CETA over the course of approximately 
8-12 weeks (approximately 1x30-60 minute session per week). At the first 
appointment, before CETA is started, the CETA therapist administers the 
PSYCHLOPS to allow the child to identify problems that are most salient to them and 
to rate the impact of those problems. This will form part of assessment, but will also 
help the therapist identify problems that the child wants help with. A Client Monitoring 
Form (CMF), a brief questionnaire that is integral to CETA and used to monitor 
problems throughout therapy, will be used at the beginning of each session.  
CETA then proceeds for up to 12 weeks (the exact number of sessions will depend 
on the nature of the problems that each child has and which CETA components are 
selected by the therapist). At an appointment midway through CETA and at the last 
appointment, the PSYCHLOPS is used to measure the child’s appraisal of the 
problem they first identified and any perceived change in the impact of that problem, 
as well as their experience of CETA. After the intervention and 3 months following 
the baseline assessment, children undergo a post-intervention assessment 
(questionnaires / interview). A final assessment is carried out 6 months after baseline 
(questionnaires / interview). Both assessments are conducted over the phone (or 
face-to-face if phone assessment is not possible) by trained assessors not involved 
in treatment provision.  
Ten children will be selected at random from the ~60 that completed at least part of a 
course of CETA and will be invited to take part in a semi-structured interview for the 
qualitative component of the study. Caregiver and child will be asked to consent to 
this interview, including an audio recording of the interview. Caregiver and child will 
be interviewed separately about their experience of CETA. Responses will be 
transcribed and translated and used to guide the development of t-CETA.  
Once t-CETA has been developed approximately 10 children will be recruited from 
the BIOPATH study or via advertisement in the Primary Healthcare Centres that 
service refugee populations in the Bekaa Valley and invited to take part in further 
development and testing of t-CETA. These 10 children will undergo a course of 
telephone-delivered CETA over the course of up to 12 weeks (approximately 1x30-60 
minute session per week). Testing over the phone will occur with the child in a private 
room at the clinic and the therapist in a nearby office. At the end of each session the 
therapist will conduct a short debrief to discuss any difficulties experienced with 
telephone delivery. Furthermore, if it is apparent during telephone delivery that the 
session is not working via phone, then the therapist can revert to face-to-face 

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Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
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treatment for the remainder of the session, thus ensuring that appropriate treatment 
has been provided to all children in this phase. 
Phase II (for review by AUB IRB): N=~120 children will be recruited and will 
undergo baseline (pre-intervention) assessment over the phone (or face-to-face if 
phone assessment is not possible) by trained assessors that are not involved in 
treatment provision. They will then be randomized to two groups: t-CETA and 
Treatment-as-usual. Stratified randomisation will be used to ensure approximately 
equal numbers of males and females and younger (8-12 years) and older (13-17 
years) children in each group. There will be an additional group of children who 
receive t-CETA but without randomization. The t-CETA groups will undergo 
telephone-delivered t-CETA over the course of up to 16 weeks (approximately 1 or 2 
x 30 minute sessions per week). The Treatment-as-usual group will be assessed by 
a Médecins du Monde clinical case manager and further treatment (e.g., 
psychological treatment) or referral to other services will be offered in line with usual 
Médecins du Monde service provision. The PSYCHLOPS will be used as in Phase I 
at the beginning, middle, and end of the treatment period.  
After the intervention and 3 months following the baseline assessment, children will 
undergo a post-intervention assessment (questionnaires / interview), again per 
phone (or face-to-face) by trained assessors not involved in treatment provision and 
blind to treatment condition. Ten children and caregiver dyads will be selected at 
random from the 60 that completed at least part of a course of t-CETA and will be 
invited to take part in a semi-structured interview for the qualitative component of 
the study. Caregiver and child will be asked to consent to this interview, including an 
audio recording of the interview. Caregiver and child will be interviewed separately 
about their experience of t-CETA. Staff who delivered t-CETA will also be interviewed 
as part of a Focus Group Discussion (FGD) to gain insight into their experience of 
delivering the intervention. Responses will be transcribed and translated for analysis. 
A final assessment will be carried out 6 months after baseline (questionnaires / 
interview).  Assessors will be blind to group condition. The assessment process will 
be supervised by a qualified clinical psychologist (Dr Tania Bosqui). 
 

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Version 2.3, 23.04.2019, t-CETA 
 
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Figure 2. Approach from BIOPATH referral to treatment 
 
Key: CP Clinical Psychologist. CM Case Manager.  
Note. In Year 2 referrals will be accepted from sources other than BIOPATH, but subsequent 
study involvement will be identical to those recruited from BIOPATH. Families unable to travel 
to the clinic will be given the option to choose t-CETA (without randomization) at recruitment; 
other than not being randomized, all other study procedures will be identical.  
 

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Version 2.3, 23.04.2019, t-CETA 
 
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Table 1. Schedule of assessments 
 
Phase I 
Phase II 
 
May – Dec 2018 
Jan – July 2019 
 
Face-to-face CETA 
N=~60 
Interview 
N=10  
(from CETA group) 
t-CETA  
development/ 
piloting 
N=10 
t-CETAC 
N=~60 
Treatment-as-usual 
N=~60 
Interview 
N=10  
(from t-CETA group) 
Recruitment 
Informed consent / 
assent 
(10-15 mins) 
n/a 
Informed consent / 
assent 
(10-15 mins) 
Informed consent / 
assent 
(10-15 mins) 
Informed consent / 
assent 
(10-15 mins) 
n/a 
Clinical assessmentB 
MINI-KID 
CGI-s score 
(30 mins child, 30 
mins caregiver) 
n/a 
MINI-KID 
CGI-s score 
(30 mins child, 30 
mins caregiver) 
MINI-KID 
CGI-s score 
(30 mins child, 30 
mins caregiver) 
MINI-KID 
CGI-s score 
(30 mins child, 30 
mins caregiver) 
n/a 
Baseline independent 
assessment (time=0) 
Phone interviewA 
(30 mins child, 30 
mins caregiver) 
n/a 
 
Phone interviewA 
(30 mins child, 30 
mins caregiver) 
Phone interviewA 
(30 mins child, 30 
mins caregiver) 
Phone interviewA 
(30 mins child, 30 
mins caregiver) 
n/a 

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Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
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TREATMENT  
(~ 8-12 weeks) 
CETA x 8-12 
sessions 
PSYCHLOPS at 1st 
session 
PSYCHLOPS at 
midway 
PSYCHLOPS at final 
session 
(each session up to 
60 mins) 
n/a 
 
t-CETA x 8-16 
sessions 
PSYCHLOPS at 1st 
session 
PSYCHLOPS at 
midway 
PSYCHLOPS at final 
session 
(each session up to 
30 mins) 
t-CETA x 8-16 
sessions 
PSYCHLOPS at 1st 
session 
PSYCHLOPS at 
midway 
PSYCHLOPS at final 
session 
(each session up to 
30 mins) 
MdM standard 
treatment 
(number, type, and 
duration of sessions 
determined by 
therapist for each 
child) 
PSYCHLOPS at 1st 
session 
PSYCHLOPS at 
midway 
PSYCHLOPS at final 
session 
n/a 
Post-intervention 
independent 
assessment (time=3 
months) 
Phone interviewA 
(30 mins child, 30 
mins caregiver) 
Informed consent / 
assent 
Qualitative interview 
(1 hour) 
Phone interviewA 
(30 mins child, 30 
mins caregiver) 
Qualitative interview / 
debrief 
(1 hour) 
Phone interviewA 
(30 mins child, 30 
mins caregiver) 
Phone interviewA 
(30 mins child, 30 
mins caregiver) 
Informed consent / 
assent 
Qualitative interview 
(1 hour) 
Follow up 
independent 
assessment (time=6 
months) 
Phone interviewA 
(30 mins child, 30 
mins caregiver) 
n/a 
n/a 
Phone interviewA 
(30 mins child, 30 
mins caregiver) 
Phone interviewA 
(30 mins child, 30 
mins caregiver) 
n/a 
A Phone interview will consist of CPSS, CES-DC, SCARED, SDQ and externalizing behaviour problems, WHO-5, YLOT, WHODAS 2.0 
B Clinical interview will not be repeated if it has already been completed, e.g., as part of the VaST study 
C t-CETA cases include those randomized to t-CETA as part of RCT and the t-CETA only (non-randomized) group 

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Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
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Version 2.3, 23.04.2019, t-CETA 
 
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Measures: Data collection will include questionnaires and standardized interviews on 
mental health disorder and mental well-being, and semi-structured interviews about 
the experience of receiving CETA or t-CETA. Caregivers and children will be 
interviewed.  
Questionnaires. Most of the questionnaires/interviews have already been used in 
similar Middle Eastern populations or have been translated and pilot tested for the 
BIOPATH study.  
 
Table 2. Constructs and Measures 
Psychopathology 
 
Construct 
Measure 
Informant 
Assessment Point 
 
PTSD 
Child PTSD Symptom Scale 
(CPSS) [12] 
Child 
Pre- and post-
intervention and at 3 
months follow up 
 
Depression 
Center for Epidemiological Studies 
Depression Scale for Children 
(CES-DC) [13] 
Child 
Pre- and post-
intervention and at 3 
months follow up 
 
Anxiety 
Screen for Child Anxiety Related 
Emotional Disorders (SCARED) [14] 
Child 
Pre- and post-
intervention and at 3 
months follow up 
 
Externalising 
behaviour 
problems 
Strengths and Difficulties 
Questionnaire (SDQ) [15] and 
Conduct Disorder / Oppositional 
Defiant Disorder items 
Caregiver 
Pre- and post-
intervention and at 3 
months follow up 
 
Clinical 
Interview 
MINI KID [16] 
Child/ 
Caregiver 
Pre-intervention  
 
 
Clinical 
severity 
Clinical Global Impression – 
severity (CGI-s) [17] 
Therapist, 
reviewing MINI 
KID and 
information 
about 
impairment 
from caregiver 
and child 
Pre-intervention 
 
Well-Being 
 
Construct 
Measure 
Informant 
 
 
Well-Being 
WHO-5 Well-Being Index (WHO-5) 
[18] 
Child 
Pre- and post-
intervention and at 3 
months follow up 
 
Optimism 
Youth Life Orientation Test (YLOT) 
[19] 
Child 
Pre- and post-
intervention and at 3 
months follow up 
 
 
Adaptive functioning 
 

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Disability 
WHODAS 2.0 child and adolescent 
[20] 
Child / 
caregiver 
Pre- and post-
intervention and at 3 
months follow-up 
 
 
 
Response to 
therapy 
PSYCHLOPS [21] 
Child / 
therapist 
Pre-, during, and post-
intervention  
 
Personality 
 
High 
sensitive 
personality 
High Sensitive Child (HSC) [22] 
Child 
Pre-intervention 
[BIOPATH data will be 
used where available; 
this will only be 
administered if 
children have not 
taken part in 
BIOPATH]  
 
 
Covariates. In addition we will also assess a range of important demographic 
characteristics and covariates including Age, Puberty Status, Gender, Ethnicity, Self-
Reported Global Health, Family Income, Parental Education, Family Structure and 
Size, Religious Affiliation, and Duration of Displacement. Relevant data collected 
during the BIOPATH study will be shared with this study, with the written consent of 
caregiver and child assent.  
Intervention. The intervention that will be used and adapted to telephone delivery is 
the Common Elements Treatment Approach (CETA), a transdiagnostic intervention 
for children presenting with mood and/or anxiety problems, developed specifically for 
use in low and middle income countries (LMIC) [11]. CETA is not a “new” 
intervention, but rather a new approach to training lay counselors—one focused on 
common elements of evidence-based treatments and decision making for treatment 
focus, element selection, sequencing and dosing. 
CETA is based on the fact that most evidence-based mental health treatments 
(EBTs) (most of which are cognitive behavioural) are made of similar elements or 
components. For example, most evidence-based treatments for a variety of disorders 
all contain psychoeducation, and cognitive coping. The idea is to train counselors in a 
range of different components that are similar across EBTs, and then teach them 
how to choose different orders and “dose” of components based on a client’s 
presenting problems. Thus, rather than training on one packaged approach 
specifically for one disorder (e.g., IPT for Depression), CETA allows counselors to 
have the skills to treat at least the big mental health problems of trauma, depression 
and anxiety, and behavioral problems for youth. This approach is thought to be 
particularly helpful in low-resource countries where the ability to train counselors in 
multiple EBTs is not likely, and there are limited counselors available. 
 
End of Study Definition  
Study will end following the completion of the final follow-up assessment in Phase II 
and when all data have been received in the UK.   
 
 
9. STATISTICAL CONSIDERATIONS  
Power analysis: A-priori sample size calculation was performed using g*power 3.1. 
Based on an assumed effect size of d = .6 and a 1:1 ratio of intervention and control, 
a total sample of 90 (45 in each arm) is required to detect significant differences with 

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Version 2.3, 23.04.2019, t-CETA 
 
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alpha = .05 and power = .80. However, we will aim to recruit 120 children (60 in each 
arm) to account for potential drop-outs. 
Data Analysis: The main comparison is between the conditions t-CETA and 
Treatment-as-usual (Phase II of study). An intention-to-treat design (using imputation 
for missing data: multiple imputation and last observation carried forward approaches 
will be considered) will be used to compare t-CETA and Treatment-as-usual groups 
on primary and secondary outcomes measures (these measures have been 
shortened and modified for Syrian refugee children during pilot work). Face-to-face 
CETA in Phase I will be used as an additional condition in analyses, unless 
substantial adjustments have been made to the design and measures before the 
main trial begins in Phase II. Data from a further group of children who receive t-
CETA, but who are not randomized, will be combined with those children who were 
randomized to t-CETA to explore efficacy (comparison of baseline, post-treatment, 
and 3-month follow up outcome scores) and implementation within the groups 
receiving t-CETA.  
Primary outcome measures:  
1. Emotional and behavioural problem composite score (derived from SCARED, 
CES-DC, CPSS, and SDQ externalising subscale plus additional externalising 
behaviour items) 
2. Adaptive functioning score (WHODAS, adapted for low resource settings) 
Secondary outcome measures: 
1. PTSD symptom score (Child PTSD Symptom Scale (CPSS)) 
2. Depression symptom score (Center for Epidemiological Studies Depression 
Scale for Children (CES-DC)) 
3. Anxiety symptom score (Screen for Child Anxiety Related Emotional 
Disorders (SCARED)) 
4. Externalising behaviour problems (Strengths and Difficulties Questionnaire 
(SDQ) externalising subscale and Conduct Disorder / Oppositional Defiant 
Disorder items) 
5. Response to intervention (PSYCHLOPS) 
6. Well-Being score (WHO5) 
7. Optimism (YLOT) 
 
t-tests and repeated measures ANCOVA (including age and gender as covariates, as 
well as other variables identified at baseline that are associated with outcomes) will 
be used to compare outcome measures between interventions and over time.  
 
10. ETHICS  
 
The Principal Investigator ensures that the study will be carried out in accordance 
with the ethical principles in the Research Governance Framework for Health and 
Social Care, Second Edition, 2005 and its subsequent amendments as applicable 
and applicable legal and regulatory requirements.  
 
Ethical approval for Phase I is from the IRB at the American University of Beirut, 
Lebanon (IRB ID: FAS.TB.06/SBS-2017-0429; 8th November 2017) and the Ministry 
of Public Health, Lebanon (10th January 2018). Caregivers have to provide written 
informed consent and children provide written assent for study participation (oral 
consent in the presence of a witness [independent of the research study] will be 
provided if participant cannot sign). Participants will be provided with oral and written 

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Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
(t-CETA) for Syrian Refugee Children in Lebanon 
Version 2.3, 23.04.2019, t-CETA 
 
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information about the study and will be given the opportunity to ask questions before 
deciding whether or not to participate. There will be approximately a week from being 
provided with information about the study over the phone and the first appointment, 
giving individuals time to consider research involvement before making a decision 
about participation. Furthermore, it will be made clear that participants can withdraw 
from the research at any point without penalty, including the option of continuing with 
treatment but without data collection.  
 
There are no conflicts of interest. 
 
11. SAFETY CONSIDERATIONS: 
Potential Risks to Human Subjects 
 
 
 
The collection of psychosocial data may cause psychological distress for some 
participants. Study participants may be distressed at recalling war events or other 
traumatic events during therapy. In our pilot work for a related study, which 
included assessment of 19 war events and 23 items dealing with childhood 
maltreatment with a questionnaire/interview, all 726 participants were asked 
whether they found it difficult to share the things that happened to them. 19.8% of 
the participants stated that they found responding to the questionnaire/interview 
difficult. All research staff involved in the fieldwork (i.e. clinical psychologists, 
case managers (social workers), and assessors) will be trained to screen for 
acute psychological distress of study participants and administer psychological 
first aid. They will inform the clinical supervisor at Médecins du Monde 
immediately, and the local PI / clinical psychologist, Dr Tania Bosqui, within 24 
hours. They will review the case, arrange further assessment as appropriate, and 
make a decision about whether participation in the trial should be discontinued. 
Discontinuation of the trial will be recommended if there has been a significant 
worsening of symptoms such that the child meets exclusion criteria (e.g., acute 
suicidal ideation, psychotic symptoms). In these cases an appropriate course of 
action will be determined by the clinical supervisor and Dr Bosqui, including 
referral to a higher level of psychological or psychiatric care, or other services as 
necessary. It is possible that participants will disclose information that indicates 
that someone is at immediate risk of harm (e.g., ongoing child maltreatment, 
suicidal ideation). Relevant information will be sought from the participant, where 
possible, including establishing whether this information has been shared with 
other agencies (e.g., child protection). The clinical supervisor will be informed 
immediately and the local PI will be informed within 24 hours and they will be 
responsible for determining the course of action. This is the only circumstance in 
which information may be shared with other agencies without consent, although 
all attempts will be made to gain consent from participating children and 
caregivers prior to sharing information, where this is appropriate and does not 
increase the risk of harm. The circumstances under which information will be 
shared will be explained at the beginning of therapy through the clinical 
agreement (verbal agreement between therapist and participant) and participants 
will be briefly reminded of this at the beginning of each therapy session and 
assessment. One CETA/t-CETA component, Safety Steps, covers safety related 
to the risk of suicidal thoughts and attempts and can be used during CETA/t-
CETA when appropriate. Further detailed safety protocols have been developed 
specifically for this research study and are based on the extensive expertise of 
the research team, Médecins du Monde’s extensive experience with Syrian 

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Version 2.3, 23.04.2019, t-CETA 
 
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refugees in this region, and experience gained during Phase I of this study. 
These include information relating to referral to other specialised agencies (e.g., 
child protection, gender-based violence). 
 
Delivering therapy and conducting assessments over the phone may introduce 
additional risks. The following steps will be taken: 
 
Emergency Referrals: For each community within which t-CETA is 
administered, relevant local services (i.e., primary healthcare clinics, child 
protection agencies) have been identified for potential emergency referrals 
before any child is treated, and in case risk issues arise during assessment, 
treatment, or follow-up. As an active provider of health services, Médecins du 
Monde has developed a strong network and professional working relationship 
with primary healthcare clinics and the main local and international child 
protection agencies operating in the field. For example, MdM arrange 
referrals to psychiatrists at FPSC (La Fundación Promoción Social de la 
Cultura), and to other agencies (e.g., child protection case management 
agencies such as IRC – International Rescue Committee and SCI - Save The 
Children International). Furthermore, we are using the Child Protection 
Working Group’s (CPWG) most recent service mapping and GBV referral 
pathway, and will remain in regular contact with UNICEF and the CPWG, to 
ensure that the research team has the most up to date information to manage 
emergency referrals. In an emergency, MdM will be able to immediately and 
directly contact and coordinate help with these organisations. We will work 
with MdM to develop their child safeguarding policy to ensure that all children 
who receive services from MdM receive the same protection. Our safety 
protocols (CP/GBV) were reviewed by experts at UNICEF/CPWG.  
 
Exclusion criteria: Given that we will select some children from the BIOPATH 
study and will conduct an intake interview prior to recruitment in all cases, 
children at severe risk of suicidal behaviour and acute maltreatment can be 
identified pre-enrolment (based on existing BIOPATH data and intake 
interview) and will be referred to the most appropriate services rather than 
included in the t-CETA trial.  
 
Security/Privacy Checks for t-CETA: Only children whose primary caretaker 
provides informed consent will be included in the study. During the consent 
process, children and their primary caretaker will be informed about the 
confidentiality of the t-CETA sessions and research staff will inquire whether 
the parent and child will be able to find a safe, private and solitary place for 
the phone assessment +/- t-CETA sessions.  
 
During the face-to-face intake assessment, the safety guidelines will be 
explained and agreed on between the case manager and the participants, to 
maximize the likelihood of ensuring safety and privacy for the participants. 
This in-depth discussion of safety guidelines will make it easier for assessors 
and t-CETA counsellors to review the safety steps with the caretaker and then 
the child when they are on the phone.  
 
The types of places that would be considered a safe space to talk will be 
identified during the face-to-face intake assessment with the caretaker and 
child, while reviewing the steps of the treatment and research, the phone 
assessment and the safety guidelines. The case manager will follow the 
guidelines for safety that are also applied for phone assessments and 
reviewed with the child and the caretaker before participating in the 
study/treatment. The importance of only giving information over the phone to 
authorised study personnel will be emphasized; they will speak to the same 

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Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention 
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Version 2.3, 23.04.2019, t-CETA 
 
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counsellor each time and will be instructed not to disclose any information if 
they do not recognise the person calling. In the rare event that it is necessary 
for a different counsellor to call, the family will be given full details of the 
alternative counsellor, and date and time of call, in advance. If, when the case 
manager calls, someone other than the participating caregiver answers the 
phone, no confidential information will be given regarding the treatment or 
research study.  
 
Case managers will ask at the beginning of each session whether the 
caregiver or child is in a safe and private place and free to talk. The call with 
the child will only be conducted after confirming over the phone with the 
caregiver that the child can find a safe and private place for the call, and the 
caregiver will be asked to help ensure this for the child (e.g., by asking others 
to leave the room).  
 
At the beginning of each t-CETA session, both the caregiver and 
child/adolescent will be asked to confirm their identity on the phone. This 
identity confirmation will be done through two main options: 
o First contact: we will make sure to review full name (+surname) and 
confirm that they had the intake assessment with (name of counsellor) 
while mentioning the period of time. We will also review what they 
agreed with the counsellor: that they will be contacted over the phone 
by a t-CETA counsellor 
o During t-CETA sessions:  
• 
With the caregiver: we will review the session we had with 
them, what we discussed regarding what the child did 
/would do in the sessions, the homework assigned to the 
child and the activities we asked the caregiver to do. We 
will also follow-up on how their week went regarding what 
we are working on with both them and their child. 
• 
With the child: we will review the activities done during the past 
session, the topic we discussed, we will ask about their 
week and we will review the homework assigned from the 
previous session.  
 
If, at any point, a participant seems uncomfortable and reluctant to answer 
questions (e.g., it’s possible that there is someone else in the room but the 
participant does not want to say so) then the case manager will suggest 
stopping the interview and calling back at another time. Additionally, prior to 
starting t-CETA an agreement will be made with the caregiver as to how to 
proceed if the connection fails, such as calling back 3 times over 15 minutes, 
then postponing until the next day. In the case of the disclosure of risk issues 
over the phone, such as risk of suicidality or suspicion of child abuse, the 
case manager will pause the session in order to manage the risk, following 
pre-prepared protocols. All risk issues, or worry about risk, will be reported by 
the case manager immediately after the phone call to the responsible clinician 
who will follow up with the family, discuss with the clinical team and develop a 
risk management plan with appropriate actions. In cases of immediate risk, 
the case manager will try to keep the family on the phone until a senior 
clinician is contacted. 
 
It is important to highlight that steps regarding interruption, increased 
exposure to risk, not being able to talk because of external interruption, or 
pauses because of therapy resistance or not feeling comfortable to continue, 

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will be agreed upon and explain thoroughly to the caretaker and to the child. 
We will be closely monitoring safety and symptoms in every t-CETA session 
using the Client Monitoring Form (a standardised tool that was developed with 
this population of Syrian refugees).  
 
Security/Privacy Checks for independent phone assessments: Independent 
assessors will follow the same guidance for managing risk over the phone. 
They will establish a safe private place to talk, they will confirm the identity of 
the child/adolescent and caregiver, they will reiterate the rules of 
confidentiality, and they will follow the same protocols if disclosure of a risk 
issue occurs. The risks are likely to be lower for phone assessments as the 
phone assessments comprise of closed questions, requiring a response such 
as “Not at all”, “A little”, “Some”, or “A lot”. Anyone who overhears the phone 
call will only hear these responses, and not the questions, which reduces the 
risk that anyone will overhear sensitive information about the child’s mental 
state.  
 
Assessors will make the calls from a private room at the American University 
of Beirut so that it will not be possible for anyone to hear their end of the call. 
Assessors will have a CITI certificate (or equivalent) and training will be 
provided on the importance of confidentiality, practical ways to ensure this 
while conducting phone assessments, and how to deal with various scenarios 
that might threaten confidentiality (e.g., someone else walks into the room). 
Training has been developed and used successfully during Phase I of the 
study, and uses a combination of scripts and role play to ensure that 
assessors are prepared to deal with challenging situations. All assessors are 
graduate students of the MSc in Clinical Psychology (or related course in 
psychology or psychiatry) at the American University of Beirut and will already 
have received training in working with vulnerable populations, in addition to 
that which is provided by the study.  
 
Access to services for families who do not wish to take part in research: 
Children from the BIOPATH study, and those approached through other 
routes, who do not take part in the t-CETA study will be offered standard 
services through MdM. This will include children who requested referral 
following the BIOPATH study but who do not meet inclusion criteria for the t-
CETA study, children who do meet inclusion criteria but exceed the number 
for recruitment to the t-CETA study, children who meet inclusion criteria but 
who do not wish to take part in the t-CETA study, and children whose 
problems are not suitable for t-CETA. Referral to MdM care as usual will be 
managed using a referral form  which will provide name and contact details 
for the caregiver and child, details about the reason for referral, and steps 
taken by the t-CETA case manager prior to/ in addition to referral. Referral will 
occur with the knowledge and consent of the caregiver and child. Two 
additional MdM staff (a case manager and a psychotherapist) are being 
funded by the BIOPATH study to help meet the additional caseload. Mental 
health services provided by MdM are free of charge.  
 
The approach will follow the standard MdM approach: initial assessment by a 
case manager and then further assessment and treatment will be determined 
based on the child’s difficulties. This might include referral to an MdM 
psychotherapist, referral to a psychiatrist (FPSC La Fundación Promoción 
Social de la Cultura), or to other agencies (e.g., child protection case 
management agencies such as IRC – International Rescue Committee and 
SCI - Save The Children International). Please see t-CETA recruitment 

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flowchart v2.1 for full details of exit points from t-CETA processes to care as 
usual.  
 
Equality of benefits to research and non-research clients: We will also take 
steps to ensure that there is not undue pressure to agree to research 
involvement in order to secure an intake assessment, treatment, or 
transportation costs. Intake assessment following screening will be offered as 
part of routine clinical care, rather than only to families interested in research. 
Families who do not want to participate in the t-CETA study will then be 
offered standard treatment at MdM.  
 
Transportation coverage will be provided using MdM’s standard approach to 
ensure that t-CETA study participants and those receiving standard MdM care 
receive the same benefits. MdM’s standard approach is to offer transportation 
costs only if a client says that they will struggle to attend an appointment. The 
case manager discusses this with the client to establish whether the cost of 
transportation is a barrier to them accessing the service. Decisions are made 
on a case-by-case basis and there is no written protocol to follow, nor is 
written information provided to clients about transportation. We have decided 
to use the same approach so as not to create undue pressure for clients to 
participate in the research; if we create more favourable conditions for study 
participants – i.e., more generous transportation coverage – then more 
vulnerable clients may feel pressure to participate for this reason. We believe 
that it would not be ethical to highlight transportation coverage to MdM clients 
because this is likely to create an expectation that will not be possible to fulfil 
for many of those receiving standard care. It is also important that the 
research study does not place additional financial pressure on MdM’s 
services by increasing demand for transportation costs. In the medium to 
longer term we will work with MdM to develop a more standardized approach 
to vulnerability assessment and decision-making about transportation costs 
so that it will be possible to put this in place for both research and care as 
usual clients.  
 
Furthermore, the study is embedded in the organizational structure of 
Médecins du Monde, including their stringent safeguards, and including 
training for all aspects of the study (research, therapy, referrals etc.) and 
regular supervision of the clinical staff. In addition: 
o Participants will be assured that participation and data collection is 
confidential  
o Participants will be assured that their participation or lack thereof in 
the study will not affect the benefits they receive from any Non-
Governmental Organizations. 
o Participants will be given the contact information of the mental health 
team at Médecins du Monde so they can contact them in case they 
desire further psychosocial support or emergency care.  
o Senior members of the research team will monitor any adverse 
psychological events. In the case of such events, an appropriate 
course of action will be determined, and can range from stopping the 
treatment, to referral to a higher level of psychological care, etc.  
 
Potential Problems and Risks Regarding the Execution of the Project 
Given the fragility of the political context in which the research will be conducted, it is 
necessary to discuss potential risks that may threaten execution of the project. 

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Political risks are always looming in the background in Lebanon. Unexpected security 
events, sectarian street fights or external wars may all break out suddenly and may 
interfere with the execution of the project, delaying certain phases or making 
transportation unsafe to a degree where research activities may not be conducted as 
planned. However, the only foreseeable major risk regarding the planned research 
activities in Lebanon is a “force majeure” such as new onset war events or security 
conditions in Lebanon that would prevent field researchers from getting to their place 
of work, the team from holding activities such as meetings, or participants from 
attending the clinic. In that instance, these activities will be conducted at a later 
period when it is safe and secure to do so. Even if security events do occur in 
Lebanon, they tend to be restricted to narrow geographical regions. The areas in 
which data collection will take place are regions that have not recently had any major 
security events, and the research team does not expect the work to stop due to 
security conditions. Even in the worst case scenario where outbreaks of fighting 
occur, this is usually limited in time, and data collection can be expected to continue 
after cessation of hostilities. Importantly, the risk for spill-over of the Syrian conflict 
into Lebanon is unlikely according to current expert prognosis.   
 
12. DATA HANDLING AND RECORD KEEPING:  
 
Confidentiality: The data will be used for clinical and research purposes only 
and collection, processing, use, and storage of the questionnaire and interview 
data will be treated with strict anonymity and confidentiality. Only the Lebanon-
based research team will have access to identifiable private information about the 
participants during the study. The names and addresses of participants will be 
kept in locked filing cabinets and on secure password protected computers and/or 
servers. Identifying data will never be kept in the same electronic file as other 
data collected during the study. Personal data that could be used to identify 
participants will not be available to the international team members. Each subject 
will be assigned an internal study ID number. A key document linking names of 
study participants and internal study IDs will be stored separately in a secure 
location (locked cabinet and password protected system on password protected 
computers). When raw data is processed and final datasets for analysis are 
created, a second ID system will be used to further reduce the risk that data can 
be matched to individual participants. Only the London-based study coordinator 
will have access to the key to match both study ID systems. 
 
Data Management and Sharing: After data collection in Lebanon, all non-
identifying data will be transferred to London where they will be processed for 
analysis. Most subsequent data preparation and analysis will be conducted at 
Queen Mary University of London where all data will be stored in the long term. 
All data will be processed centrally at Queen Mary University of London and 
stored in standard formats for use with statistical software (e.g., SPSS) after data 
cleaning and quality control and shared with the named co-investigators and 
collaborators for analysis.  
 
Record Retention and Archiving: After the funding period has ended, the data 
will be curated by the London based principal investigator. Once data has been 
collected and processed, it will be stored long-term on password-protected 
secure servers. Data generated will be stored for at least 20 years, in line with 
QMUL SOPs.  
 
13. LABORATORIES  
 

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N/A 
  
 
14.  PRODUCTS, DEVICES, TECHNIQUES AND TOOLS  
 
All psychological and psychosocial measures and interventions are described in 
section 8 (see Table 2. Constructs and Measures).  
  
15. SAFETY REPORTING  
 
AEs or SAEs are unlikely in this study as the procedures are low risk. However, any 
adverse events will be reported to and recorded by the Lebanon-based trial 
coordinator. SAEs will be immediately reported to the London-based study 
coordinator, who will report to the CI, sponsor, and American University of Beirut IRB 
when appropriate. The Lebanon-based trial coordinator will also report to the the 
local PI / clinical psychologist, Dr Tania Bosqui, within 24 hours so that appropriate 
clinical care (including referral to other services, if necessary) can be provided. AEs 
will be recorded and reported to the PI, London-based study coordinator, and DSMC 
monthly. Where necessary, they will be discussed with the PI and Study Coordinator 
during weekly skype meetings to agree on follow up or changes to treatment. 
 
If the safety of the study participants or field work staff is believed to be at risk 
because of changes to the security situation in Lebanon then the CI, in discussion 
with the Lebanon-based PI, Co-I, and study coordinators, may make the decision to 
suspend or postpone data collection in some regions. In this event, the sponsor and 
American University of Beirut IRB will be informed by phone immediately and in 
writing within 3 days.  
 
 
16. MONITORING & AUDITING 
 
Development of SOPs for all aspects of the study will be carried out in consultation 
with relevant experts, and under the guidance of the JRMO, to ensure compliance 
with relevant UK and Lebanese laws.  
 
A trial steering group (see section 17 for details) will review the protocol before each 
phase of data collection begins. Annual review by the steering group will also cover 
study milestones, difficulties and delays, and preliminary data analysis and results. 
They will suggest modifications to the protocol in light of review of the study progress 
and with changing ideas and emerging technologies in their fields of work.  
 
Changes to the protocol will be reviewed by the sponsor and the IRB at the American 
University of Beirut. Where appropriate, advice will be sought from specific members 
of the trial steering group when changes to the protocol are being developed and 
prior to submission to the sponsor and IRB.  
 
The Lebanon-based trial coordinator (Mr Chéhadé) will be responsible for monitoring 
recruitment and data collection. He will ensure that staff have entered all data into 
study databases and that these have been backed up. The Lebanon-based trial 
coordinator will report daily to the London-based study coordinator regarding 
recruitment and data collection. They will report on a weekly basis regarding whether 
recruitment and data collection targets are being met, and plans for future 
recruitment and data collection.  

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The London-based study coordinator (Dr. McEwen) will monitor data collection 
regularly by reviewing data uploaded to the Qualtrics server and will check that other 
databases have been backed up onto remote servers. She will identify any problems 
with meeting recruitment and data collection targets, as well as any other problems 
or breaches of protocol or SOPs and will report these to the CI (Prof. Pluess).  
 
Clinical / technical supervision 
 
Adequate clinical supervision is an important aspect of the study and will be provided 
separately for CETA/t-CETA and TaU staff. Supervision for the CETA/t-CETA will be 
provided by Laura Murray and Stephanie Skavenski, with Roland Weierstall acting in 
an advisory capacity. Staff delivering exclusively TaU will be integrated into the MdM 
Mental Health team structure and supervision will be provided by the dedicated 
clinician who supervises that team.   
 
The clinical psychologist who leads the t-CETA study, Nicolas Chéhadé, will be 
supervised by Laura Murray (and/or Stephanie Skavenski). Case managers working 
on the t-CETA study will be supervised directly by Nicolas Chéhadé. CETA staff will 
receive the following clinical supervision per week (during treatment periods): 
- 
Weekly one to two-hour skype supervision with Laura Murray (and/or 
Stephanie Skavenski) for Nicolas Chéhadé 
- 
Weekly two-hour face-to-face supervision meetings with Nicolas Chéhadé for 
case managers delivering CETA or t-CETA 
- 
Weekly one/two-hour skype or face-to-face supervision for Nicolas Chéhadé 
and case managers by Tania Bosqui on intake interviews, diagnostic 
decisions, and managing risk issues 
- 
Ad-hoc supervision for Nicolas Chéhadé and case managers by Tania Bosqui 
on urgent/ emergency cases.  
 
MdM Treatment as Usual:  
- 
The psychotherapist and case manager will be integrated into the MdM 
Mental Health team and will receive weekly supervision from the MdM 
external clinical expert  
 
Prof. Pluess will be responsible for overall monitoring of study progress and of 
submitting reports to the funder, sponsor, and IRB. Progress reports will be prepared 
by Prof. Pluess, Dr. McEwen, and Dr. Bosqui.  
 
17. TRIAL COMMITTEES 
Research Team:  
The proposed study represents a strong collaboration between researchers from four 
leading research institutions in Europe, USA and the Middle East and an experienced 
international non-governmental medical humanitarian organisation: 
 
 
Queen Mary University of London (QMUL, UK): QMUL is ranked 9th in the 
UK for research quality and committed to achieving the highest quality 
research to tackle the most challenging and pressing research problems. 
 
Johns Hopkins Bloomberg School of Public Health (JHSPH, USA): JHSPH is 
the largest school of public health in the world with research ongoing in the 
USA and more than 90 countries worldwide.  

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 
American University of Beirut (AUB, Lebanon): AUB is ranked as the number 
one university in Lebanon and is among the top 250 universities in the world.  
 
Medical School Hamburg (MSH, Germany): MSH is a new private state-
approved university for health and medicine, founded in 2009. 
 
Médecins du Monde (MdM, Lebanon): For more than 35 years, MdM has 
been caring for the most vulnerable populations. MdM currently works in 44 
countries across all continents. MdM has been working in Lebanon for nearly 
30 years and specifically on the response to the Syrian crisis since 2012. The 
goal of MdM in Lebanon is to offer medical care to Syrian refugees and 
vulnerable Lebanese affected by this crisis. Currently, medical assistance, 
including mental health and psycho-social support, is provided through three 
partners in four primary healthcare centres in the Beqaa valley.    
 
We will appoint a Trial Steering Group comprising at least two members of the study 
team and at least 2 independent members with expertise in clinical trials and/or 
psychological interventions. A similar advisory board is already in place for the 
BIOPATH study. Furthermore, we will work closely with the IASC Reference Group 
on Mental Health and Psychosocial Support in Emergency Settings. Importantly, the 
global IASC coordinator, the national mental health programme lead in Lebanon as 
well as all leading mental health stakeholders in Lebanon have already been 
consulted and informed in person by Prof. Pluess about the details of the proposed 
study. 
 
Involvement in development of proposal 
All partners actively contributed to the design of the study and have been involved in 
the write up of the proposal under the leadership of Prof. Pluess.  
 
Commitment and ownership of local research partners: The local partners are 
involved in all questions and aspects regarding the research design and 
management of the study. MdM are highly committed to research as they have 
proven in the ongoing BIOPATH collaboration with Prof. Pluess over the last year. 
The current proposal reflects an equal and established collaboration with local 
partners, characterised by equity, transparency and mutual benefit. 
 
History of Partnership: Prof. Pluess and his team have been collaborating with MdM 
and Dr Hijazi (AUB) over the last year in relation to a large ongoing NIH funded study 
on resilience of Syrian refugee children in Lebanon (BIOPATH). The collaboration 
with Drs Murray and Bolton from JHSPH, Dr Weierstall from MSH, and Dr Bosqui 
from AUB represents a new addition to the already established partnership between 
Prof. Pluess, Dr Hijazi, and MdM. 
 
Quality of research consortium: The research consortium features an exceptionally 
strong team of world leading experts and is well positioned to conduct the planned 
work to the highest standard. Dr Murray is the original author of CETA and together 
with Ms Skavenski highly experienced in training and supervision of CETA providers 
in low and middle income countries. Drs Bolton and Murray have also extensive 
experience in conducting randomised controlled trials to test the efficacy and 
implementation of CETA. Further expertise in transcultural trauma research and 
treatment is provided by Dr Weierstall. MdM have a long history of providing 

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excellent health services in Lebanon and are perfectly suited to oversee the field 
work given their ongoing involvement in research.  
 
PI: Prof. Pluess is currently heading a large study on resilience of Syrian refugees in 
Lebanon, supported by Dr McEwen. He and his team are familiar with the challenges 
and opportunities of cross-cultural international research as well as the specific 
refugee context in Lebanon. Over the last three years he established strong 
connections to the major mental health stakeholders in Lebanon, including the 
Ministry of Public Health, UNICEF, UNHCR and several NGO’s. 
 
Building capacity of local researchers: The study will build on and strengthen the 
research capacity already set up at MdM for the BIOPATH study and provide local 
researchers as well as students and lay providers with the opportunity to get involved 
in the study and acquire new skills (data collection, CETA training and delivery). 
 
Steering Group 
Membership 
• 
Michael Pluess (chair) 
• 
Fiona McEwen 
• 
Representative for MdM (tbc) 
• 
Representative for Clinical Team (tbc) 
• 
Two independent experts (e.g., with expertise in clinical trials, mental health 
in refugee communities): Rabih El Chammay and Mary Deeb 
 
Role 
To set overall scientific direction of trial, develop and agree trial design, identify and 
suggest solutions to challenges, monitor trial progress.  
Meeting schedule 
1. 
Before trial begins 
2. 
At conclusion of trial when preliminary data analysis has been conducted 
 
Data Safety Monitoring Committee 
Membership 
• 
Michael Pluess (chair) 
• 
Fiona McEwen 
• 
Lead clinical psychologist on study 
• 
Representative for MdM or clinical team (tbc) 
• 
Two independent experts (e.g., with expertise in clinical trials, statistician): 
Rabih El Chammay and Mary Deeb 
 
Role 
To monitor data collection and management (including randomisation and blinding 
procedures), to monitor for adverse events and appropriate response to adverse 
events, to ensure that all data is managed to the standards expected of a 
randomised controlled clinical trial.  
 

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Meeting schedule 
1. 
Before trial begins 
2. 
Immediately after completion of t-CETA vs. TaU leg in Phase II 
 
Ongoing monitoring 
At the first meeting the committee shall agree on methods of monitoring data safety 
on an ongoing basis, decide on reporting procedures, and monitor according to these 
procedures for the duration of the trial. 
 
 
18. FINANCE AND FUNDING 
All costs will be covered with external grant money from R2HC.  
 
 
19. INDEMNITY  
 
The IRB at the American University of Beirut, QMUL, and Médecins du Monde have 
agreed that indemnity is not required during Phase I because participants will be 
provided with a treatment that is not novel and that does not pose any greater risk 
than the clinical care provided by Médecins du Monde.  
 
For Phase II, the insurance that Queen Mary University of London has in place 
provides "No Fault Compensation" for participants which provides an indemnity to 
participants for non-negligent harm. 
 
20. DISSEMINATION OF RESEARCH FINDINGS 
 
Study results will be published in peer-reviewed journals and presented at scientific 
conferences. Additionally, summaries will be prepared for dissemination among 
NGOs and other agencies working with refugee populations.  
 
 
21. REFERENCES 
 
 
 
1. 
UNHCR. Syria Regional Refugee Response Inter-agency Information 
Sharing Portal. 2016  [cited 2016 29.11.2016]; Available from: 
http://data.unhcr.org/syrianrefugees/regional.php. 
2. 
UNHCR Global Trends 2011. 2012. 
3. 
Greca, A.M. and W.K. Silverman, Treatment and Prevention of 
Posttraumatic Stress Reactions in Children and Adolescents Exposed to 
Disaster and Terrorism: What is the Evidence? Child Development 
Perspectives, 2009. 3(1): p. 4-10. 
4. 
Bronstein, I. and P. Montgomery, Psychological distress in refugee 
children: a systematic review. Clinical Child and Family Psychology 
Review, 2011. 14(1): p. 44-56. 
5. 
Sirin, S.R. and L. Rogers-Sirin. The educational and mental health 
needs of Syrian refugee children. . 2015; Available from: 

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http://www.migrationpolicy.org/sites/default/files/publications/FCD-
Sirin-Rogers-FINAL.pdf. 
6. 
Hassan, G., et al., Culture, Context and the Mental Health and 
Psychosocial Wellbeing of Syrians: A Review for Mental Health and 
Psychosocial Support staff working with Syrians Affected by Armed 
Conflict. 2015, UNHCR: Geneva. 
7. 
el Chammay, R., W. Kheir, and H. Alaouie, Assessment of Mental 
Health and Psychosocial Support Services for Syrian Refugees in 
Lebanon. 2013: UNHCR; Beirut, Lebanon. 
8. 
Frueh, B.C., et al., A randomized trial of telepsychiatry for post-
traumatic stress disorder. Journal of telemedicine and telecare, 2007. 
13(3): p. 142-147. 
9. 
Mohr, D.C., et al., Telephone-administered psychotherapy for 
depression. Archives of General Psychiatry, 2005. 62(9): p. 1007-1014. 
10. 
Murray, L.K., et al., Building capacity in mental health interventions in 
low resource countries: an apprenticeship model for training local 
providers. Int J Ment Health Syst, 2011. 5(1): p. 30. 
11. 
Murray, L.K., et al., A Common Elements Treatment Approach for Adult 
Mental Health Problems in Low- and Middle-Income Countries. Cogn 
Behav Pract, 2014. 21(2): p. 111-123. 
12. 
Foa, E.B., et al., The Child PTSD Symptom Scale: A preliminary 
examination of its psychometric properties. Journal of clinical child 
psychology, 2001. 30(3): p. 376-384. 
13. 
Faulstich, M.E., et al., Assessment of depression in childhood and 
adolescence: an evaluation of the Center for Epidemiological Studies 
Depression Scale for Children (CES-DC). Am J Psychiatry, 1986. 
143(8): p. 1024-7. 
14. 
Birmaher, B., et al., The screen for child anxiety related emotional 
disorders (SCARED): scale construction and psychometric 
characteristics. Journal of the American Academy of Child & Adolescent 
Psychiatry, 1997. 36(4): p. 545-553. 
15. 
Goodman, R., The Strengths and Difficulties Questionnaire: a research 
note. Journal of child psychology and psychiatry, 1997. 38(5): p. 581-
586. 
16. 
Sheehan, D.V., et al., The Mini-International Neuropsychiatric Interview 
(M.I.N.I.): the development and validation of a structured diagnostic 
psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry, 1998. 
59 Suppl 20: p. 22-33;quiz 34-57. 
17. 
Busner, J. and S.D. Targum, The clinical global impressions scale: 
applying a research tool in clinical practice. Psychiatry (Edgmont), 
2007. 4(7): p. 28-37. 
18. 
Topp, C.W., et al., The WHO-5 Well-Being Index: A Systematic Review 
of the Literature. Psychotherapy and Psychosomatics, 2015. 84(3). 
19. 
Ey, S., et al., A new measure of children's optimism and pessimism: 
The youth life orientation test. Journal of Child Psychology and 
Psychiatry, 2005. 46(5): p. 548-558. 

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20. 
Scorza, P., et al., Validation of the "World Health Organization 
Disability Assessment Schedule for children, WHODAS-Child" in 
Rwanda. PLoS One, 2013. 8(3): p. e57725. 
21. 
Ashworth, M., C. Evans, and S. Clement, Measuring psychological 
outcomes after cognitive behaviour therapy in primary care: a 
comparison between a new patient-generated measure “PSYCHLOPS” 
(Psychological Outcome Profiles) and “HADS” (Hospital Anxiety and 
Depression Scale). Journal of Mental Health, 2009. 18(2): p. 169-177. 
22. 
Pluess, M., et al., Environmental Sensitivity in Children: Development 
of the Highly Sensitive Child Scale and Identification of Sensitivity 
Groups in revision.