Culturally Adapted Strong Families Programme for Families Living in Gilgit Baltistan, Pakistan

Study Overview
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Brief Summary
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The aim of this exploratory study is to test the Strong Family (SF) programme in improving family functioning when implemented in Gilgit-Baltistan. Participants will be randomized to one of the two study arms 1)- Intervention group in which participants will receive 3 group sessions of SF programme (8-12 families per group) 2)- Control group (control group will be in the waiting list and receive SF training sessions once the study will be completed).

Detailed Description
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This will be multicentre feasibility randomised controlled trial to test the effectiveness of the SF programme in improving family skills outcomes and caregiver and child mental health, as reported by caregivers when implemented in Gilgit-Baltistan. The study will record families' rates of recruitment and attendance to SF programme, evaluate the completeness of programme delivery, cultural acceptability through qualitative interviews and assess the fidelity of training delivery. A small pilot study with N=10 families (a female caregiver (mother) and one child between the age of 8-15 years from each family) will be conducted before main RCT. The study will be conducted in three districts including; Gilgit, Hunza and Skardu in Gilgit Baltistan, Pakistan. We will interview a subset of participants i.e. up to 5 caregivers from each study site (N=15 caregivers) to explore participants' opinions on the acceptability of the programme and to explore any barriers or facilitators to participation.

Official Title
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Culturally Adapted Strong Families Programme to Improve Child Behavior and Family Functioning in Families Living in Gilgit Baltistan, Pakistan

Conditions
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Mental Health

Intervention / Treatment
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* Behavioral: Strong Families Programme Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female primary caregiver to a child aged between 8-15 years Able to speak and understand Urdu language Capable to give informed consent Exclusion Criteria: Families that had already taken part in another family skills training programme in the past 6 months or where the caregiver lived separately from the child Not the primary caregiver of the child Unlikely to be available for the duration of the whole study and outcome assessments (e.g., temporary residence).
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strong Family Programme Intervention<br>There will be 3 weekly group sessions of the strong family programme with caregivers and children (8-12 families per group). | Behavioral: Strong Families Programme Intervention<br>* This is a family skills programme providing an evidence-informed prevention to support caregivers to be better parents and strengthen positive age-specific and age-appropriate family functioning and interactions to help prevent drug use, violence and other negative social consequences in their children.<br>|
| Active Comparator: Waitlist control group<br>This group will be on the waiting list and receive SF programme training sessions once the study will be completed. | Behavioral: Strong Families Programme Intervention<br>* This is a family skills programme providing an evidence-informed prevention to support caregivers to be better parents and strengthen positive age-specific and age-appropriate family functioning and interactions to help prevent drug use, violence and other negative social consequences in their children.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability indicators | We will record feasibility indicators in terms of families' rates of recruitment and attendance to programme, and programme completeness. To evaluate cultural acceptability of programme by families, interviews with caregivers will be conducted to explore family members' opinions on the acceptability of the programme, any barriers or facilitators to participation. | From baseline to end of intervention at 3 weeks (post randomisation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strengths and Difficulties Questionnaire | The Strengths and Difficulties Questionnaire is a brief behavioural screening questionnaire and ask about 25 attributes, some positive and others negative. This will be administered to both child and the caregiver. | At baseline, week 5 and week 9 of post baseline | 
| Parenting and Family Adjustment Scale | This will measures parenting practices and parental adjustment. This scale has been developed to be used in low resource settings. | At baseline, week 5 and week 9 of post baseline | 
| Child and Youth Resilience Measure | This is a screening tool to explore the resources available that may bolster resilience. | At baseline, week 5 and week 9 of post baseline |