Multi-Component Early Intervention for Socially Inhibited Preschool Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Change in child anxiety disorder symptoms
研究概览
简要总结
This project is intended to provide a rigorous test of the Turtle Program, an early intervention program for behaviorally inhibited preschoolers. The proposed project will extend promising pilot study findings by: (a) evaluating the integrated intervention in a larger sample (n = 150) of 45-64 month children and their parents, which will allow for an examination of mediators and moderators of treatment effects; (b) comparing the Turtle Program to the best available treatment for preschool behavioral inhibition, the Cool Little Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation as both baseline moderators of treatment response and as outcome measures; (d) examining parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment assessment and extending follow-up to one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Months 至 64 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire
排除标准
- •child has a diagnosis of pervasive developmental disorder, selective mutism, or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety; child does not have a custodial parent who has also consented to participate
结局指标
主要结局
Change in child anxiety disorder symptoms
时间窗: pre-treatment, mid-treatment (week 4), post-treatment (week 8), and 1-year follow-up
Assessed with diagnostic interviews (Anxiety Disorders Interview Schedule) with parents
次要结局
未报告次要终点
研究者
Andrea Chronis-Tuscano
Professor
University of Maryland, College Park