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Trial details
Assistant Professor of Clinical Psychology
Current status:
Approved
|
Date registered:
26/11/2021
|
Date last updated:
16/11/2021
Trial version(s)
History: 13/10/2021
Current: 13/10/2021
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2021104870
Protocol number
SBS-2021-0102
MOH registration number
Pending
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
13/10/2021
Primary sponsor
Tania Bosqui
Primary sponsor: Country of origin
UK
Public title
Assistant Professor of Clinical Psychology
Acronym
Scientific title
Dr
Acronym
Brief summary of the study: English
There is a small yet growing evidence base for psychosocial interventions in conflict and humanitarian emergencies, however adolescent mental health is often under-researched and drastically under-resourced. Families play a critical role in ensuring adolescent mental health and protection outcomes, yet there has been limited research evaluating family interventions in these settings. This study aims to develop and test a family systemic program that can be delivered alongside the existing UNICEF Focused-Psychosocial Support (FPSS) curriculum for at-risk adolescents in Lebanon. Phase 1 involved the development and piloting of the family module, while Phase 2 will evaluate the program using a single-blind hybrid effectiveness-implementation randomized control trial. Through the development and evaluation of an adjunctive family systemic program we will enhance current humanitarian programming by addressing the child’s ecology, while also addressing a significant weakness of the current evidence base for at-risk adolescents and their families in conflict-affected contexts. The program aims to be systemic, culturally and contextually relevant, and sustainable. The participatory, hybrid effectiveness-implementation design will ensure that the intervention is optimally contextualized, and suited for wide-scale implementation.
Brief summary of the study: Arabic
هناك قاعدة أدلة صغيرة لكن متنامية للتدخلات النفسية والاجتماعية في حالات النزاع والطوارئ الإنسانية، وغالبًا ما تشهد الصحة النفسية للمراهقين قلّة في الأبحاث ونقصاً كبيراً في الموارد. تلعب العائلات دورًا أساسياً في ضمان الصحة النفسية للمراهقين وحمايتهم، ومع ذلك كان هناك بحث محدود لتقييم التدخلات الأسرية في هذه السياقات. تهدف هذه الدراسة إلى تطوير واختبار برنامج نُظُمي للأسرة يمكن تقديمه جنباً إلى جنب مع منهج اليونيسف للدعم النفسي والاجتماعي المركّز (FPSS) للمراهقين المعرضين للخطر في لبنان. تضمنّت المرحلة الأولى تطوير واختبار وحدة الأسرة، في حين أن المرحلة الثانية ستقيّم البرنامج باستخدام تجربة عشوائية مضبوطة وفردية التعمية تمزج بين الفعالية والتنفيذ. عبر تطوير وتقييم برنامج نُظُمي عائلي مساعد ، سنعمل على تعزيز البرمجة الإنسانية الحالية من خلال معالجة بيئة الطفل، مع معالجة الضعف الكبير في قاعدة الأدلة الحالية للمراهقين المعرضين للخطر وأسرهم في السياقات المتأثرة بالنزاع. يهدف البرنامج إلى أن يكون منهجيًا ومستداماً وملائما ثقافياً وسياقياً. سيضمن التصميم التشاركي المازج بين الفعالية والتنفيذ أن يكون التدخل مثالياً لسياقه ، ومناسبًا للتنفيذ على نطاق واسع.
Health conditions/problem studied: Specify
Parent and adolescent mental health and wellbeing.
Interventions: Specify
A 7 session family focused psychosocial support program, named the Sawa A2wa Family Program.
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion criteria for participation in the research study are 1) a single- or dual-headed household with an adolescent aged 12-18 (male and female), 2) identified as at-risk by the partner organization, 3) scoring above the cutoff on the Pediatric Symptom Scale for general mental health, and 4) gives assent and parental/legal guardian consent. One target child will be identified per family for the assessments (if multiple children meet the criteria in one family, the child who has the highest PSC score will be selected as the index child). At-risk status will be established as part of usual screening processes for focused PSS and clinical assessment by facilitators in partner organizations, who will identify and referral potential participants. Medium-to-high risk is defined for this study as being ‘vulnerable to a protection risk but not high with imminent risk (i.e. without a current protection risk that would require immediate referral to case management). Once potential participants give verbal permission to be contacted by the research team, and have consented/assented to take part, they will be screened fully by the research team (including administering the short-form of the Pediatric Symptom Checklist) to ensure they meet the inclusion criteria and that the program is relevant to their needs.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
12
Key inclusion and exclusion criteria: Age maximum
17
Key inclusion and exclusion criteria: Exclusion criteria
Participants will be excluded if they have severe psychiatric disturbance or risks requiring specialist mental health services (assessed by partner organizations as part of usual routine assessment and referral systems), if they are in immediate high risk requiring case management, or if they do not consent/assent. Cases requiring specialized services will not be invited to participate because of the level of vulnerability, potential issues of capacity, and because the family intervention is unlikely to be pitched at the right level for their needs, though they will be offered alternative relevant services. The decisions are made using the usual protocol for focused PSS programs within each partner organization by experienced mental health and child protection teams. Due to the high level of need within all communities in Lebanon, and the need to prevent resource-based tension between groups, we will include families from all nationalities, religions, and refugee status.
Type of Study
Type
Interventional
Type of intervention
Other
Type of intervention: Specify type
Family systemic focused psychosocial support
Trial scope
Other
Trial scope: Specify scope
Psychosocial support
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Active
Study phase
1 to 2
Study design: Purpose
Other
Study design: Specify purpose
Psychosocial family support
Study design: Assignment
Single
Pharmaceutical class
Not applicable.
Therapeutic indication
Not applicable.
Therapeutic benefit
It is expected that the research directly and immediately benefits the participants in the RCT (through receiving family psychosocial support) at no cost to participants. Research clearly indicates benefits of family-based interventions but this not currently available for most vulnerable families living in Lebanon. If successful, we aim to integrate the module into standard care alongside existing focused PSS activities. These benefits to the community are likely to occur gradually in the 1-2 years following the analysis and publication of the trial data.
Biospecimen retention
None retained
Biospecimen description
Not applicable.
Target sample size
270
Actual enrollment target size
351
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
15/11/2021
Date of study closure: Type
Anticipated
Date of study closure: Date
30/09/2022
Recruitment status
Pending
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement description
Collection and management of data will be in accordance with IRB and American Psychological Association (APA) standards, as well as the EU General Data Protection Regulation (since WCH is headquartered in Europe). All project staff will be provided with Good Clinical Practice (GCP) training through AUB, and additional training addressing research ethics, assent/consent, and child interviewing. Short term storage and backup Data will be stored, short-term, on secure servers, accessed through individual password protected accounts on password protected encrypted computers. Only project members who require access will have an account. Unique participant identifiers will be used, with outcome data stored separately from personal information. Identifying information will be stored on REDCap, a secure web-based system specifically designed for clinical trials, and measures will be completed and data stored on LimeSurvey, a secure survey software tool accessible through AUB. Excel files will also be used to track progress, and these will use only unique identifiers (no names), will be password protected, and stored on Dropbox, with encryption via Boxcryptor. Long term storage Personal identifiers and audio recordings of semi-structured interviews will be destroyed after 5 years from publication of the study, in keeping with APA and IRB ethical standards for psychological research. All other data (raw outcome data, qualitative transcripts) will be preserved by the Department of Psychology, AUB, for long term archiving in AUB’s secure data bank. This is appropriate because it provides security against loss of data, and access if needed in the longer term. Data sharing Data will be co-owned by AUB and WCH. Non-identifiable data (such as unlinked questionnaire data) will be held by the research team for up to 3 years, for analysis. After 3 years, non-identifiable data will be made available through AUB’s data bank (see http://aub.edu.lb.libguides.com/data_services/databank). The PI will be responsible for managing data and responding to access requests from external users, provided data sharing agreements detailing responsibilities of users in handling and sharing data have been agreed and signed. In line with open science initiatives, external researchers will be able to access non-identified data via information provided in publications. Identifiable data will be archived on RedCap, in a locked filing cabinet in the implementing partner organization (consent/assent forms), or on a password protected encrypted computer (audio recordings) for 5 years and then deleted/destroyed, in keeping with usual practice for psychological research. This data will not be shared with external users to protect confidentiality and anonymity.
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
American University of Beirut
Family ID
Sources of Monetary or Material Support
Name
AHRC/ DfID (award number:103916)
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Tania
Bosqui
Department of Psychology, AUB
Lebanon
AUB ext: 4370
tb33@aub.edu.lb
American University of Beirut
Scientific
Tania
Bosqui
Department of Psychology, AUB
Lebanon
AUB ext: 4370
tb33@aub.edu.lb
American University of Beirut
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Other
American University of Beirut
12/10/2021
Nadine Kamal
nk93@aub.edu.lb
AUB ext: 5455
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Mental health and wellbeing
Mental disorder, not otherwise specified (F99)
Mental health, wellbeing
Interventions
Intervention
Description
Keyword
Sawa A2wa Family Program
The 7 session family focused psychosocial support program includes 90 minute weekly family session and 30 minute weekly parenting sessions, with the exception of the 7th booster session delivered one month after the end of the program. The program will be delivered via non-specialists and aims to improve family functioning and adolescent mental health.
Family systemic, psychosocial
Primary Outcomes
Name
Time points
Measure
Adolescent mental health
Pre, post, 3 month follow-up
Pediatric Symptom Checklist
Key Secondary Outcomes
Name
Time points
Measure
Wellbeing
Pre, post, 3 month follow-up
WHO-5 Well-Being Index
Family functioning
Pre, post, 3 month follow-up
SCORE Index of Family Functioning and Change
Emotion regulation
Pre, post, 3 month follow-up
Difficulties in Emotion Regulation Scale
Child protection risk, stress and adversity
Pre, post, 3 month follow-up
Standardized measure developed for the study
Parenting
Pre, post, 3 month follow-up
Parenting Questionnaire
Caregiver mental health
Pre, post, 3 month follow-up
Kessler 6
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial