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

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05933850
• Other study ID #: PILL-SFP-GB-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Pakistan Institute of Living and Learning
• Contact: MUQADDAS ASIF
• Phone: 03364057787
• Email: muqaddasasif[@]pill.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Mental Health

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning	UNODC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At baseline, week 5 and week 9 of post baseline
Secondary	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.	At baseline, week 5 and week 9 of post baseline
Secondary	Child and Youth Resilience Measure	This is a screening tool to explore the resources available that may bolster resilience.	At baseline, week 5 and week 9 of post baseline