VIA Family - Family Based Early Intervention Versus Treatment as Usual- 4 Year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Change in "Strength and Difficulties Questionnaire" (SDQ)
研究概览
简要总结
This study aims to investigate the long-term effects (2.5 years after post-intervention) of a preventive family-based intervention (VIA Family) compared with treatment as usual (TAU) for children of parents with a severe mental illness.
Background:
Children of parents with a mental illness have an increased lifetime risk of developing a mental illness themselves. Preventive interventions for families with children with high familial risk can potentially disrupt the transgenerational transmission.
The current study is a follow-up study of a trial investigating the effect of the preventive intervention: the VIA Family trial.
The VIA Family trial investigated the superiority of a preventive family-based intervention, VIA Family, compared with treatment as usual (TAU) in improving children's, parents' and families' functioning and well-being. Eligible families had at least one parent with a lifetime severe mental illness diagnosis ( i.e. recurrent major or moderate depression, bipolar disorder, or schizophrenia spectrum disorder), at least one child between the ages of 6-12 years and lived within the Frederiksberg or Copenhagen (Denmark). The trial had a randomized, two-armed, parallel and controlled design. The participating families were randomly assigned to both groups with an allocation ratio of 1:1.
The current study is a follow-up study aiming to explore the effect of the intervention 2.5 years after post-intervention.
The main research questions for the current follow-up study are:
- Do children participating in the VIA Family intervention experience a greater decrease in symptoms of mental illness from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with children allocated to TAU?
- Do parents participating in the VIA Family intervention experience a greater decrease in perceived parental stress from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with parents allocated to TAU?
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
- •Child must have address registered in the municipality of Frederiksberg or Copenhagen.
- •At least one of the biological parents must have a diagnosis of schizophrenia spectrum disorder, bipolar affective disorder or recurrent major depression.
- •The parent with a diagnosis must have had at least one in- or outpatient contact with the mental health system within the lifetime of the child.
排除标准
- •Parents who do not speak and understand enough Danish to be able to give informed consent for their own and for the child's participation.
- •If all family members are currently engaged in an intensive family intervention program addressing parental functioning and child development, they are excluded from the study.
结局指标
主要结局
Change in "Strength and Difficulties Questionnaire" (SDQ)
时间窗: Change from baseline to 4 years follow-up
Parent reported 25-items questionaire of their child's behavioural and emotional difficulties, 3-point Likert scale (0,1,2), higher scores indicate more emotional or behavioral problems
次要结局
- Health-Related Quality of Life Questionnaire: KIDSCREEN -10(Change from baseline to 4 years follow-up)
- Personal and Social Performance Scale (PSP)(Change from baseline to 4 years follow-up)
- Change in Children's Global Assessment Scale (CGAS)(Change from baseline to 4 years follow-up)
- Change in Family Assessment Device (FAD)(Change from baseline to 4 years follow-up)
- Change in Home Observation for Measurement of the Environment (HOME)(Change from baseline to 4 years follow-up)
- This is Me (TIM)(Change from baseline to 4 years follow-up)
- Parental Stress Scale (PSS)(Change from baseline to 4 years follow-up)
- Parenting Scale (PS)(Change from baseline to 4 years follow-up)