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NCT Number: NCT05933850

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

The aim of this exploratory study is to test the Strong Family (SF) programme in improving family functioning. 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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Community setting

Karachi, 75600, Pakistan

Location status: Recruiting

Location contact

Asif Community setting

CONTACT

[email protected]

02135871845

About this study

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 sites including Karachi, Lahore and 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Feasibility and acceptability indicators

    Time frame: From baseline to end of intervention at 3 weeks (post randomisation)

    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.

Secondary outcomes

  1. Strengths and Difficulties Questionnaire

    Time frame: At baseline, week 5 and week 9 of post baseline

    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.

  2. Parenting and Family Adjustment Scale

    Time frame: At baseline, week 5 and week 9 of post baseline

    This will measures parenting practices and parental adjustment. This scale has been developed to be used in low resource settings.

  3. Child and Youth Resilience Measure

    Time frame: At baseline, week 5 and week 9 of post baseline

    This is a screening tool to explore the resources available that may bolster resilience.

Study contacts

Contact information is provided by the study sponsor or research team.

MUQADDAS ASIF

CONTACT

[email protected]

03364057787

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

  • UNODC

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 6, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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