A Pilot Randomized Controlled Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- acceptability
研究概览
简要总结
The overall aim of this pilot study is to evaluate the acceptability and feasibility of an adaptation of Beardslee's 'Preventive Intervention Program (PIP) for Depression' in Chilean families.
The PIP is a family intervention directed towards strengthening family functioning and enhancing resilience in children of depressed parents. It comprises several modules that work on psycho-education and skill development within the family nucleus.
A single-blind randomized controlled trial will be conducted with two arms, the intervention arm (n=32) which will receive a home-based PIP for depression, and the TAU arm (n=32).
详细描述
Being a child with depressed parents is associated with poor health and academic outcomes as well as having four times the likelihood of developing a mood disorder compared to children of non-depressed parents.
Objectives: To evaluate acceptability and feasibility of an adaptation of Beardslee's 'Preventive Intervention Program (PIP) for Depression' in Chilean families, and to measure the clinical effects of this intervention.
Participants: Parents with an episode of Depression in the past 3 months with at least one non-depressed child between the ages of 6-12.
Design: single-blind randomized controlled trial with two groups; the intervention group (n=32), which will receive a home-based PIP for depression, and the treatment-as-usual control group (n=32).
Results: Acceptability and feasibility will be measured by determining whether the trial was successfully conducted and well received by the families and preventionists. Recruitment and delivery of the intervention will be assessed as well as whether there was appropriate response and follow-up, and whether the objectives of the study were reached. Secondary outcomes will look at depressive symptoms, family function, psycho-education, parental competence, adaptive behavior and resilience in children.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are currently undergoing a depressive episode or have done so in the past 3 months.
排除标准
- •For parents:
- •Alcohol or drug dependence or abuse as assessed by the MINI or being in treatment for substance use.
- •Psychosis, personality disorder, bipolar disorder or suicide ideation as assessed by the MINI.
- •Having a relationship crisis with current partner. Assessed by self-report or by having attended couple's therapy in the past month.
- •Attending family therapy.
- •For children:
- •Being outside the age range of 6-12 years at the time of recruitment.
- •Intellectual disability
- •Having depression as assessed by the MINI Kid
- •Being in treatment for a psychiatric disorder or having taken psychotropic medication in the last month.
结局指标
主要结局
acceptability
时间窗: 7 weeks
The acceptability of the intervention will be evaluated through qualitative questionnaires.
feasibility
时间窗: 7 weeks
Feasibility will be assessed by looking at the number of families succesfully completing the study.
次要结局
- Parental competence(11 months)
- Depressive symptoms in children(11 months)
- Depressive symptoms in parents(11 months)
- Family functioning(11 months)
- Adaptive behaviour in children(11 months)
- resilience in children(11 months)
研究者
Matias Irarrazaval
Dr. Matias Irarrazaval MD MPH
University of Chile