Culturally Adapted Strong Families Programme to Improve Child Behavior and Family Functioning in Families Living in Gilgit Baltistan, Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Feasibility and acceptability indicators
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female primary caregiver to a child aged between 8-15 years
- •Able to speak and understand Urdu language
- •Capable to give informed consent
排除标准
- •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).
研究组 & 干预措施
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).
干预措施: Strong Families Programme Intervention (Behavioral)
Waitlist control group
This group will be on the waiting list and receive SF programme training sessions once the study will be completed.
干预措施: Strong Families Programme Intervention (Behavioral)
结局指标
主要结局
Feasibility and acceptability indicators
时间窗: 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.
次要结局
- Parenting and Family Adjustment Scale(At baseline, week 5 and week 9 of post baseline)
- Strengths and Difficulties Questionnaire(At baseline, week 5 and week 9 of post baseline)
- Child and Youth Resilience Measure(At baseline, week 5 and week 9 of post baseline)