Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB).
研究概览
简要总结
The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will include children with:
- •parent/guardian aged 18 years or older with a child aged between 4.0 to 17.11 years old at the time of parental consent;
- •diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., ADOS) or suspicion of ASD diagnosis and confirmed with Autism Diagnostic Interview-Revised (ADI-R);
- •parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility;
- •stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes;
- •English-speaking parent and youth able to consistently participate in study procedures;
- •family resides in United States.
排除标准
- 未提供
研究组 & 干预措施
Remote (Telehealth) Intervention Program
干预措施: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth (Behavioral)
结局指标
主要结局
Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB).
时间窗: Screening, Baseline, every 2 weeks, 12 weeks, 24 weeks
DARB insistence on sameness subscale scores measure insistence on sameness with higher scores indicating greater intensity of insistence on sameness. \[Score Range: 0-76\]
次要结局
- Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings.(Baseline, 12 weeks)
- Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment.(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale.(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R).(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7).(Baseline, 12 weeks)
- Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS).(Baseline, 12 weeks)
- Change from Baseline in Family Accommodation Scale - RRB (FAS-RRB).(Baseline, 6 weeks, 12 weeks)
- Daily Living Skills Scale (DLSS).(Baseline, Week 12)
- Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21).(Baseline, 12 weeks)
- Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ).(Baseline, Week 12)
- Caregiver Report Executive Functioning Scale (EFS).(Baseline, Week 12)
研究者
Antonio Hardan
Professor of Psychiatry and Behavioral Sciences
Stanford University