Feasibility Trial of Learning Through Play (LTP) in My Own Way Plus CBT A Parent-Based Intervention for Depressed Mothers With ID Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Session Log (Feasibility and acceptability)
研究概览
简要总结
Aim of the study is to evaluate the acceptability and feasibility of LTP in My Own Way Plus with depressed mothers of ID children.
详细描述
Having a child with a chronic medical problem or an intellectual disability increases anxiety and depression in parents. There is some growing evidence that families of ID children are able to meet the challenges. The purpose of the present study is to adapt LTP in my own way plus to test its acceptability and determine if it improves mothers knowledge about their child development and reduce their level of distress.
The study has two phases: quantitative phase and qualitative phase. Quantitative phase: A single blind randomised controlled trial in school settings in Karachi Pakistan.
Objectives:
- Help mothers cope better with their depression.
- Teach mothers play activities that will stimulate their children's development and improve mother-child interaction.
Qualitative Phase: This will help to determine acceptability of the intervention and identify perceived mechanisms of change and any barriers and facilitators to LTP in my own Plus intervention. In-depth digitally recorded interviews and focus groups will be conducted with the parents and teachers to understand their beliefs, views, and feelings about caring for ID children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Researchers doing outcome assessments will be kept blind to treatment allocations
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mothers of ID children aged 3 to 6 years, screened positive for depression
- •Ability to complete a baseline assessment
- •Ability to communicate in Urdu or English
排除标准
- •Have a diagnosed serious medical or psychiatric condition
- •Mothers of children with other medical illness
- •Temporary residents unlikely to be available for follow-up
结局指标
主要结局
Session Log (Feasibility and acceptability)
时间窗: change in baseline to 12 weeks
sessions logs (attendance of each participant) will be maintained.
次要结局
- Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003):(change in baseline to 12 weeks)
- Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):(change in baseline to 12 weeks)
- Vineland Adpative Behaviour Scales (VABS-II) VABS-II (Sparrow et al., 2005):(change in baseline to 12 weeks)