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

Pakistan Institute of Living and Learning

Status: Not yet enrolling

Conditions: Mental Health

Treatments: Behavioral: Strong Families Programme Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05933850

PILL-SFP-GB-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Strong Family Programme Intervention

Experimental group

Description:

There will be 3 weekly group sessions of the strong family programme with caregivers and children (8-12 families per group).

Treatment:

Behavioral: Strong Families Programme Intervention

Waitlist control group

Active Comparator group

Description:

This group will be on the waiting list and receive SF programme training sessions once the study will be completed.

Treatment:

Behavioral: Strong Families Programme Intervention