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JRMO Non-CTIMP Protocol Template Project: 012344 Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon 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: [email protected] REC Reference SBS-2018-0582 (IRB of American University of Beirut, Lebanon). Chief Investigator Dr. 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: [email protected] 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 Version 2.2, 21.09.2018, t-CETA Page 1 of 34 Project: 012344 Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon Lebanon Phone +961 1 350 000 ext: 4370 Email: [email protected] Study Team PI Dr. 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 Version 2.2, 21.09.2018, t-CETA Page 2 of 34 Project: 012344 Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon 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 Version 2.2, 21.09.2018, t-CETA Page 3 of 34 Project: 012344 Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon 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 Version 2.2, 21.09.2018, t-CETA Page 4 of 34 Project: 012344 Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon 3. SIGNATURE PAGE Chief Investigator Agreement The clinical study as detailed within this research protocol (Version 2.0, dated 16th July 2018), 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: 21/09/2018 Principal Investigator Agreement (if different from Chief investigator) The clinical study as detailed within this research protocol (Version 2.0, dated 16th July 2018), 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: 21/09/2018 Version 2.2, 21.09.2018, t-CETA Page 5 of 34 Project: 012344 Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon 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 8-16 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 8-12 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 Version 2.2, 21.09.2018, t-CETA Page 6 of 34 Project: 012344 Title: Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon Participants/Patients Main Inclusion Criteria Lebanon-based Syrian refugee children of Arabic ethnicity aged 8-16 years and scoring above threshold on standard measures of psychopathology Statistical Randomised controlled trial: comparison of t-CETA to Methodology and treatment as usual on key outcome measures. Analysis (if applicable) 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 January 2019 Proposed
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