Evaluation of the New Orleans Intervention for Infant Mental Health in Glasgow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 2
- 主要终点
- Change in score on the Infant-Toddler Social-emotional Assessment (ITSEA)
研究概览
简要总结
Early intervention for maltreated infants can improve mental and physical health throughout life and benefit families and society as a whole. The New Orleans Model provides intensive assessment and treatment for families of maltreated preschool children in foster care, with recommendations to court about adoption, or permanent return to birth families. The New Orleans Model appears to have led to better informed decisions about permanent placement and to better child mental health in Louisiana. The investigators propose an exploratory randomised controlled trial investigating the effectiveness of the New Orleans Model in the Scottish context, informing the development of an economic model to explore the potential cost-effectiveness. Families with a maltreated child under 5 years of age will be offered the New Orleans Model or "case management" i.e. quality assured services as usual, using random allocation. The investigators will measure outcome using well validated measures of parent-child interaction, cognition and attachment.
详细描述
The first 5 months of this trial - from December 2011 to April 2012 - is an internal pilot or "implementation period". During this time we have fewer research staff, both services will just have started and we will only be collecting selected outcome measures. These will be the Principle Outcome Measure, the Infant-Toddler Social-Emotional Assessment (ITSEA), plus the Disturbance of Attachment Interview (DAI) and Parent-Infant Global Assessment of Functioning (PIR-GAS). We hope to include data from implementation period in our trial analysis, but if results are very different due to services "bedding in", we may not do so
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 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All maltreated children placed in foster care, aged between 6 and 60 months, whose parents give informed opt-in consent
排除标准
- •Children with profound learning disability
结局指标
主要结局
Change in score on the Infant-Toddler Social-emotional Assessment (ITSEA)
时间窗: Baseline and at 1 year follow-up
The ITSEA is a well validated parent/carer-completed questionnaire covering a wide range of social and emotional behaviours in infants and preschool children. It has been shown to be sensitive to change in previous intervention research with maltreated children with medium to large effect sizes and has good longitudinal stability.
次要结局
- Cognitive assessment(Baseline and 1 year follow up)
- The Parent Evaluation of Development (PEDS)(Baseline and 1 year follow up)
- This is My Baby (TIMB)(Baseline and 1 year Follow up)
- The Use of Services Questionnaire(Baseline and 1 year follow up)
- The Disturbances of Attachment Interview (DAI)(Baseline and 1 year follow up)
- The Parent-Infant Global Assessment of Functioning (PIR-GAS)(Baseline and 1 year follow up)
- The Strange Situation Procedure (SSP)(1 year follow up only)
- The Development and Wellbeing Assessment (DAWBA)(Baseline and 1 year follow up for children over 2 years.)
研究者
Helen Minnis
Principal Investigator
University of Glasgow