Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).
研究概览
简要总结
The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).
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
Outcome raters and video coding rating are blinded to group.
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion;
- •Boys and girls between 2.0 and 5.11 years;
- •Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;
- •Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;
- •Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;
- •No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);
- •No more than 60 minutes of individual 1:1 speech therapy per week;
- •Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.
排除标准
- •Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
- •Receiving ABA of 15 hours or more;
- •Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
- •Previous adequate Pivotal Response Treatment (PRT) trial;
- •Participants living more than 30 miles from Stanford University;
- •Child's primary language other than English.
研究组 & 干预措施
Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
A 16-week center-based PRT intervention (PRT-C) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.
干预措施: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) (Behavioral)
Treatment As Usual (TAU)
This is a control group that consists of children who are receiving treatment as usual (TAU) for a 16-week period. These families will be invited to participate in PRT after completing the 16-week TAU phase.
Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)
A 16-week home-based PRT intervention (PRT-H) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.
干预措施: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H) (Behavioral)
结局指标
主要结局
Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).
时间窗: Baseline,16 Weeks.
次要结局
- Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment.(Baseline,16 Weeks.)
- Change on MacArthur-Bates Communication Development Inventory (CDI) Scores(Baseline,16 Weeks.)
- Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores(Baseline,16 Weeks.)
- Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores(Baseline,16 Weeks.)
- Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores(Baseline,16 Weeks.)
- Change on the Clinical Global Impressions (CGI) Scale.(Baseline,16 Weeks.)
研究者
Antonio Hardan
Professor
Stanford University