Neurally Targeted Interventions to Reduce Early Childhood Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 8
- 主要终点
- Change in Error Related Negativity (ERN)
研究概览
简要总结
Clinically significant anxiety affects 20% of preschoolers and can become chronic, leading to depression, substance abuse, school-drop out and even suicide. To reduce anxiety and prevent its sequelae, clinically affected children must be effectively treated early. Available interventions for clinically anxious preschoolers are effective for some, but not all children, with as many as 50% of 4-7 year olds continuing to meet criteria for an anxiety disorder after treatment.
This trial aims to help learn how Camp Kidpower, trainings using either structured games or a playgroup, may lower anxiety in preschool age children. Playing these games and learning that kids can do it, can teach kids how to keep going when they are feeling anxious. To find out if Kidpower works by helping kids stay in charge of their behaviors and emotions, the study will look at parts of the brain as well as behaviors related to effortful control and fear, before and after training.
The study hypothesizes that Kidpower will produce greater increases in Error-related negativity (ERN), Interchannel Phase Synchrony (ICPS) and effortful control (EC) behaviors than in the Playgroup control.
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)
盲法说明
The rater will be blinded to which intervention, structured games or playgroup, child participants receive.
入排标准
- 年龄范围
- 48 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between ages 4 -5.99 years at time of consent
- •Children that have a primary clinical diagnosis of separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, panic disorder, and/or obsessive-compulsive disorder
- •Written informed consent by a parent/legal guardian and verbal assent from participant
- •Fluent in English
排除标准
- •History of head injury
- •History of serious medical or neurological illness
- •History of post-traumatic stress disorder (PTSD)
- •History of major depressive disorder (MDD)
- •Current psychotherapy or behavioral interventions
- •History of Neurodevelopmental delay, autism spectrum disorder (ASD), or intellectual disability
- •Currently taking medications that affect central nervous system functioning
- •Primary clinical diagnosis is selective mutism or specific phobia
- •Recent history of physically aggressive behaviors that have caused harm to other children
- •Sibling of a child who has participated or is currently participating in this protocol
结局指标
主要结局
Change in Error Related Negativity (ERN)
时间窗: Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
The error-related negativity is a neurophysiological signal, measured via electroencephalogram (EEG), considered to reflect a dorsal anterior cingulate cortex (ACC) response to errors. For this study the ERN will be measured at electrode site FCz as the downward (negative voltage) deflection of the EEG signal that occurs 50-100 msec after error commission on the Zoo Task. Scores are measured continuously (no established minimum or maximum) . Higher scores reflect greater neural capacity for effortful control.
Change in National Institutes of Health (NIH) Toolbox Effortful Control (EC) Composite Scale
时间窗: Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
The NIH Toolbox EC Composite Scale will be comprised of children's standardized scores reflecting accuracy and reaction time on two computerized tasks: the Flanker inhibitory control and attention task and the Dimensional Change Card Sort (DCCS) test of set-shifting function. An NIH Toolbox EC Composite score will be based on factor loadings for each task derived from a factor analysis of scores across both Toolbox tasks. Scores are measured continuously (no established minimum or maximum) . Higher scores reflect greater behavioral capacity for effortful control.
Change in Clinical Global Impressions -Severity and Improvement Scales
时间窗: Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks)
The Clinical Global Impressions (CGI) is an observer rated scale used to assess anxiety severity (CGI-S) and pre- to post-treatment improvement in anxiety (CGI-I). Ratings for both use a 7-point scale, from 1 "normal" to 7 "among the most severely ill" for CGI-S and 1 ("very much improved") to 7 ("very much worse") for CGI-I.
次要结局
- Change in Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)(Pre-treatment (baseline) and post-treatment assessments (approximately 4-6 weeks))
- Change in Spence Preschool Anxiety Scale (Spence PAS)(Pre-treatment (baseline) up to post-treatment assessments (approximately 4-6 weeks))
研究者
Kate D. Fitzgerald, MD
Ruane Professor of Child and Adolescent Psychiatry
Columbia University