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

May 24, 2026 updated by: Pakistan Institute of Living and Learning

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strong Family Programme Intervention
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 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.
Active Comparator: Waitlist control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and acceptability indicators
Time Frame: From baseline to end of intervention at 3 weeks (post randomisation)
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
Time Frame: At baseline, week 5 and week 9 of post baseline
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
Time Frame: At baseline, week 5 and week 9 of post baseline
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
Time Frame: At baseline, week 5 and week 9 of post baseline
This is a screening tool to explore the resources available that may bolster resilience.
At baseline, week 5 and week 9 of post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Living and Learning

Collaborators

UNODC

Investigators

  • Principal Investigator: Salman Shahzad, Pakistan Institute of Living and Learning

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

July 2, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PILL-SFP-GB-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After 2 years of trial completion.

IPD Sharing Access Criteria

The data could be requested from the corresponding author with a reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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