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

Official title

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

Overview

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).

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.

Interventions

• 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.

Primary outcome measures

• Feasibility and acceptability indicators [Time frame: From baseline to end of intervention at 3 weeks (post randomisation)]

Secondary outcome measures (3)

• Strengths and Difficulties Questionnaire [Time frame: 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]
• Child and Youth Resilience Measure [Time frame: At baseline, week 5 and week 9 of post baseline]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Pakistan · 1 center

• Community setting — Karachi

Publications

• El-Khani A, Asif M, Shahzad S, Bux MS, Maalouf W, Rafiq NUZ, Khoso AB, Chaudhry IB, Van Hout MC, Zadeh Z, Tahir A, Memon R, Chaudhry N, Husain N. Assessing the efficacy of a brief universal family skills programme on child behaviour and family functioning in Gilgit-Baltistan, Pakistan: protocol for a feasibility randomised controlled trial of the Strong Families programme. BMJ Open. 2024 Jul 1;14( PMID 38951006

Identifiers

NCT: NCT05933850 · PILL-SFP-GB-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗