Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2021
INTERVENTION: Randomisation will occur after T0 assessments are completed, and will be stratified by implementing partner/site. Participants will be randomly allocated to intervention or waitlist with a 1:1 ratio. The randomisation sequence will be computer‐generated by a statistician located outside Lebanon, and independent of the study. Families are randomised into the following conditions: 1. Intervention: The intervention is a six‐session family intervention programme to be delivered by non‐specialist facilitators. Family members will attend weekly 2‐hour long sessions together, and the programme will be delivered by one facilitator with one family. The first 1.5 hours is delivered to the family unit. The final 0.5 hours consists of a brief session for the caregivers only. After the 6th session, a 7th booster session of 2 hours will be provided after approximately 1 month. The programme was developed by the study team and partners in Lebanon through formative research, and covers these main skills: identifying family values, goals, challenges, and strengths; emotional regulation; communication; problem management; managing disagreements; positive parenting for adolescents. 2. Waitlist: The waitlist families will receive the programme after post‐intervention assessments (T1). They will receive the programme in a group format, and with or without concurrent child‐focused programmes, to assess the feasibility and acceptability of different delivery formats. Assessments will be conducted at pre‐intervention (T0), post‐intervention (T1), and 3‐month follow‐up for the treatment group only (T2). CONDITION: Families identified as having medium to high protection risk, and an adolescent aged 12‐17 years who scores above the clinical cut‐off on a measure of psychological symptoms ; Not Applicable PRIMARY OUTCOME: Child‐reported mental health and behavioural symptoms measured with the 35‐item Pediatric Symptom Checklist at T0, T1, T2 (the primary comparison is change from T0 to T1 between groups) SECONDARY OUTCOME: ; 1. Child‐reported wellbeing measured with the 5‐item WHO‐5 Wellbeing Index at T0, T1, T2 (the primary comparison is the change from T0 to T1 between groups); 2. Child‐reported emotional regulation challenges measured with the 18‐item Difficulties in Emotion Regulation Scale ‐Short Form at T0, T1, T2 (the primary comparison is the change from T0 to T1 between groups); 3. Child‐reported family functioning measured with the 15‐item Systemic Clinical Outcome and Routine Evaluation (SCORE) Index of Family Function at T0, T1, T2 (the primary comparison is the change from T0 to T1 between groups); 4. Caregiver‐reported parenting skills measured with the War Child Parenting Scale at T0, T1, T2 (the primary comparison is the change from T0 to T1 between groups); 5. Caregiver‐reported psychological distress measured with the Kessler 6 scale at T0, T1, T2 (the primary comparison is the change from T0 to T1 between groups); 6. Caregiver‐reported emotional regulation challenges measured with the 18‐item Difficulties in Emotion Regulation Scale ‐Short Form at T0, T1, T2 (the primary comparison is the change from T0 to T1 between groups); 7. Caregiver‐reported family functioning measured with the 15‐item Systemic Clinical Outcome and Routine Evaluation (SCORE) Index of Family Function at T0, T1, T2 (the primary comparison is the change from T0 to T1 between groups); ; Mediators: The potential mediating effect of secondary outcomes on the primary outcome will be explored; ; Moderators: The study is not powered for moderation effects, however, the researchers will conduct exploratory analyses of moderating effects of key demographic variables (e.g. age, gender), and exposure to potentially traumatic events and current adversities (using a checklist developed for this study).; INCLUSION CRITERIA: 1. A single‐ or dual‐headed household with an adolescent aged 12‐17 years (male and female) 2. Identified as at‐risk by the partner organisation 3. Scoring above the cutoff on the Paediatric Symptom Scale for general psychological distress 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 refer 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 imm
Epistemonikos ID: 733f7fd119e5df7003b7bfa333aac131edc8ef36
First added on: Aug 25, 2024