Clinical trial NCT05933850: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: UNODC
First posted: 2023-07-06
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Feasibility and acceptability indicators
timeFrame: From baseline to end of intervention at 3 weeks (post randomisation)
Secondary outcomes:
measure: Strengths and Difficulties Questionnaire
timeFrame: At baseline, week 5 and week 9 of post baseline
measure: Parenting and Family Adjustment Scale
timeFrame: At baseline, week 5 and week 9 of post baseline
measure: Child and Youth Resilience Measure
timeFrame: At baseline, week 5 and week 9 of post baseline
Other outcomes:
Locations:
Study officials:
affiliation: Pakistan Institute of Living and Learning
name: Salman Shahzad
role: PRINCIPAL_INVESTIGATOR
References: