Addressing Anxiety in 2-Year-Olds: A Pilot Screening and Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I)
研究概览
简要总结
The purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children with elevated anxiety and their parents, using a parent-child Cognitive Behavioral Therapy (CBT) protocol to reduce anxiety disorders and maintain reduced anxiety at one-year follow-up. Before the COVID-19 pandemic, study visits and treatment sessions were conducted in office. Now all visits and treatment sessions are conducted remotely.
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
- 21 Months 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The child scores >1 Standard Deviation (SD) above reported means for the Fear or Shyness scales on the Early Childhood Behavior Questionnaire (ECBQ) (if child is 21-35 months) or the child scores >1SD above reported means for the Total Anxiety, Generalized Anxiety, Social Anxiety, Physical Injury Fears, or Separation Anxiety scales on the Preschool Anxiety Scale (PAS) (if child is 36-47 months) as completed by a parent
- •The parents are able to speak, understand, and read English
- •The child must have a working knowledge of English.
排除标准
- •Autism Spectrum Disorder (ASD) or global developmental delay in the child
- •The child has disruptive behavior so severe as to interfere with participation in intervention sessions
- •The child has a different primary disorder for which CBT for anxiety is inappropriate (e.g. severe depression, depression in the mother, significant medical disorder).
研究组 & 干预措施
Parent Education
Parents receive educational materials about how to help young children overcome shyness and anxiety
干预措施: Parent Education (Other)
Monitoring
Active Treatment
Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol
干预措施: Being Brave (Behavioral)
结局指标
主要结局
Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I)
时间窗: Baseline to four-month follow-up
The CGI-I is a 7-point scale from 1 (Very Much Improved) to 7 (Very Much Worse). It will be rated by a clinician interviewer blind to treatment condition
Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I)
时间窗: Baseline to four-month follow-up
The CGI-I is a 7-point scale from 1 (Very Much Improved) to 7 (Very Much Worse). It will be rated by a clinician interviewer blind to treatment condition
CGI-Severity Ratings
时间窗: Compared between groups at 4- and 8-month FU
次要结局
未报告次要终点
研究者
Dina R. Hirshfeld-Becker
Co-Director, MGH Child CBT Program
Massachusetts General Hospital