A Multi-Method Early Intervention Program for Inhibited and Anxious Preschoolers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in child anxiety disorder symptoms
研究概览
简要总结
This project aims to develop and evaluate a novel early intervention program that targets the specific risk factors implicated in the development and persistence of shyness, social reticence, and withdrawal in children. The project includes a program development phase, Phase I (pilot test of full study procedures using developed treatment protocol), and Phase II (randomized controlled trial/RCT). Outcomes that will be assessed include change in child behavioral inhibition and parenting, using parent and teacher reports and observational data. Families are assessed at three time points: baseline, post-treatment (or at approximately 8 weeks for the control group), and 2 month follow-up.
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
- 42 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire; child has a biological parent with at least 50% physical custody who consents to participate
排除标准
- •Child has a diagnosis of pervasive developmental disorder or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety
研究组 & 干预措施
Turtle Program
The Turtle Program involves a child social and emotional skills group (Social Skills Facilitated Play) and a modification of Parent-Child Interaction Therapy in which parents are provided in-vivo coaching in following their children's lead and encouraging approach behaviors within the peer context. The child group provides a forum of same-age peers to learn to develop social and emotion regulation skills. The Turtle Program is administered over an 8-week period.
干预措施: Turtle Program (Behavioral)
Waitlist Control
Untreated comparison group during the study, received parent psychoeducation intervention after the active treatment group.
干预措施: Parent Psychoeducation (Behavioral)
结局指标
主要结局
Change in child anxiety disorder symptoms
时间窗: Pre-treatment (baseline), post-treatment (week 8), and 2-month follow-up
Assessed with diagnostic interviews (Preschool Age Psychiatric Assessment) 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