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

NCT ID: NCT05933850

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Strong Family Programme Intervention

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

Group Type EXPERIMENTAL

Strong Families Programme Intervention

Intervention Type 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.

Waitlist control group

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

Group Type ACTIVE_COMPARATOR

Strong Families Programme Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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UNODC

UNKNOWN

Sponsor Role collaborator

Pakistan Institute of Living and Learning

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salman Shahzad

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Living and Learning

Central Contacts

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MUQADDAS ASIF

Role: CONTACT

03364057787

References

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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.

Reference Type DERIVED
PMID: 38951006 (View on PubMed)

Other Identifiers

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PILL-SFP-GB-001

Identifier Type: -

Identifier Source: org_study_id

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