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Clinical Trials/NCT05933850
NCT05933850
Not Yet Recruiting
N/A

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

Pakistan Institute of Living and Learning0 sites90 target enrollmentJune 1, 2024
ConditionsMental Health

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Health
Sponsor
Pakistan Institute of Living and Learning
Enrollment
90
Primary Endpoint
Feasibility and acceptability indicators
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Parenting and Family Adjustment Scale(At baseline, week 5 and week 9 of post baseline)
  • Strengths and Difficulties Questionnaire(At baseline, week 5 and week 9 of post baseline)
  • Child and Youth Resilience Measure(At baseline, week 5 and week 9 of post baseline)

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