Parent-implemented Treatment for Repetitive Behaviors in Children With ASD: Using a Novel Telehealth Approach to Increase Service Access.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Behavioral Inflexibility Scale - Clinical Interview
研究概览
简要总结
The overall goal of this project is to determine whether a new form of family-based treatment for repetitive and inflexible behaviors, delivered using videoconferencing technology, can counter any negative effects of those behaviors, but also improve positive outcomes for young children with ASD.
详细描述
The overall goal of this project is to conduct a parallel group randomized controlled trial comparing remote delivery of FITBI (13-week intervention + 3 booster sessions over 6 months) to remote delivery of a parent education only (PE) control condition in a final sample size of 100 (3 years, 0 months to 9 years, 6 months) children with ASD and high rates of ritualistic repetitive behaviors. We will use TORSH, a comprehensive secure online platform that enhances therapist-parent coaching via telehealth. Further, an important objective of this proposal is to examine child and parent factors associated with treatment response and uptake in order to advance translational research and knowledge on personalized intervention approaches. Thus, the aims of this project are to:
Aim 1: Examine the acute and distal effects of the FITBI intervention on child and parent outcomes.
H1: In comparison to a PE only condition, FITBI will result in reductions in children's repetitive behaviors and increases in appropriate play skills immediately post-treatment.
H2: Effects of the FITBI intervention will be maintained at a 6-month follow-up and increases in child adaptive functioning and decreases in parent stress will be found.
Aim 2: Determine if the FITBI intervention shows differential treatment effects for lower versus higher order repetitive behaviors.
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
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASD criteria on Social Communication Questionnaire-Lifetime and Autism Diagnostic Interview-Revised.
- •Between ages of 3 years, 0 months and 9 years, 6 months
- •exhibiting clinically significant levels of repetitive behavior (Score >26 on Repetitive Behavior Scales-Revised
- •prior clinical or medical diagnosis of autism spectrum disorder
排除标准
- •diagnosed comorbid genetic disorder known to associated with increased symptom severity
- •child engages in serious self-injurious behavior with intensity or frequency that warrants hospitalization
- •change in psychotropic medications within last 6 weeks
- •child already receives >20hours per week of home-based ABA services
结局指标
主要结局
Behavioral Inflexibility Scale - Clinical Interview
时间窗: 6 months
video interview yields a severity score from 0 no impairment to 28 maximum impairment
次要结局
- Direct Observation of Repetitive Behaviors in Autism (DORBA)(Baseline, 12 weeks, and 6 month follow-up)
- Aberrant Behavior Checklist-Community (ABC-C)(Baseline, 6 weeks, 12 weeks, and 6 month follow-up)
- Behavioral Inflexibility Scale (BIS)(Baseline, 6 weeks, 12 weeks, and 6 month follow-up)