An interventional study of Strong Families Programme Intervention in Mental Health, sponsored by Pakistan Institute of Living and Learning. Recruiting at 1 site in Pakistan. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Pakistan Institute of Living and Learning · Not applicable, Interventional, and Prevention
The aim of this exploratory study is to test the Strong Family (SF) programme in improving family functioning. 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).
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 sites including Karachi, Lahore and 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.
Exclusion Criteria:
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
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
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.
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.
Time frame: From baseline to end of intervention at 3 weeks (post randomisation)
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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline, week 5 and week 9 of post baseline
Plan to share: Yes — De-identified individual participant data (IPD) will be shared with other researchers, encompassing essential information such as demographic details, primary and secondary outcome measures, intervention exposure metrics, and process evaluation data. Rigorous measures will be implemented to ensure the complete de-identification of the data and safeguard the anonymity of individual participants.
Supporting information: Study protocol, Sap, Icf
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Pakistan Institute of Living and Learning