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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Feasibility and acceptability indicators [Срок оценки: From baseline to end of intervention at 3 weeks (post randomisation)]

Вторичные конечные точки (3)

• Strengths and Difficulties Questionnaire [Срок оценки: At baseline, week 5 and week 9 of post baseline]
• Parenting and Family Adjustment Scale [Срок оценки: At baseline, week 5 and week 9 of post baseline]
• Child and Youth Resilience Measure [Срок оценки: At baseline, week 5 and week 9 of post baseline]

Критерии участия

Критерии включения

• Female primary caregiver to a child aged between 8-15 years
• Able to speak and understand Urdu language
• Capable to give informed consent

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Пакистан · 1 центр

• Community setting — Karachi

Публикации

• 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( PMID 38951006

Идентификаторы

NCT: NCT05933850 · PILL-SFP-GB-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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