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

NCT05933850 | Not Yet Recruiting DMC

• 1 other identifier: PILL-SFP-GB-001
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Mental Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Strengths and Difficulties Questionnaire

  At baseline, week 5 and week 9 of post baseline

• Parenting and Family Adjustment Scale

  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

Study Arms (2)

Strong Family Programme Intervention

EXPERIMENTAL

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

Waitlist control group

ACTIVE COMPARATOR

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

Interventions

Strong Families Programme Intervention BEHAVIORAL

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.

Strong Family Programme Intervention; Waitlist control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Respecting the cultural context, either males or females' caregivers can be engaged at one time in our study setting. As females are most often the primary caregivers in Pakistan, female primary caregivers and their children (of either gender) will be invited to participate in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female primary caregiver to a child aged between 8-15 years
• Able to speak and understand Urdu language
• Capable to give informed consent

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• UNODC: collaborator

Related Publications (1)

• 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(6):e081557. doi: 10.1136/bmjopen-2023-081557.

  PMID: 38951006 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Salman Shahzad

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUQADDAS ASIF

CONTACT

03364057787; muqaddasasif@pill.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 6, 2023
• Study Start: October 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After 2 years of trial completion.
• Access Criteria: The data could be requested from the corresponding author with a reasonable request.