Pivotal Response Treatment Package for Young Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks
研究概览
简要总结
This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism.
详细描述
Researchers at the Stanford University School of Medicine are seeking participants for a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement PRT with in-home, therapist-implemented treatment. To determine the effectiveness of a PRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid clinicians in providing better care for children with autism.
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
- None
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 (ADOS-2), and expert clinical opinion
- •Males and females in good medical health 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: Standard score at least 1 Standard Deviation below average for expressive language ability
- •Stable treatment, speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
- •No more than 60 minutes of individual 1:1 speech therapy per week
- •Availability of at least one parent who can consistently participate in parent training and research measures
- •Parents intend on continuing Pivotal Response Treatment Package (PRT-P) for a minimum of 12 weeks
- •Parents must be 18 years of age or older
排除标准
- •Current or lifetime diagnosis of severe psychiatric disorder, such as bipolar disorder
- •Receiving in-home Applied Behavior Analysis (ABA) of 10 hours or more
- •A genetic abnormality, such as Fragile X
- •Presence of active medical problem, such as unstable seizure disorder or heart disease
- •Previous adequate PRT trial
- •Participants living more than 50 miles from Stanford University
- •At least one room of the house must be available to be dedicated to treatment during session times
- •There must be no serious health and safety risks present in the home environment
- •The research team has the right to refuse to perform sessions in-home even if the criteria above are met
结局指标
主要结局
Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks
时间窗: 6, 12 and 24 weeks
次要结局
- Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks(6, 12, and 24 weeks)
- Change from Baseline on the Preschool Language Scale, 5th Edition (PLS-5) at 12, and 24 weeks(12 and 24 weeks)
- Change from Baseline on the Sensory Profile Questionnaire at 6, 12, and 24 weeks(6, 12 and 24 weeks)
- Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks(6, 12 and 24 weeks)
- Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks(6, 12 and 24 weeks)
- Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks(6, 12 and 24 weeks)
- Change from Baseline on the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P) at 6, 12, and 24 weeks(6, 12 and 24 weeks)
- Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks(6, 12, and 24 weeks)
- Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks(6, 12, and 24 weeks)
- Change from Baseline on the Social attention and word-learning eye tracking task at 12, and 24 weeks(12, and 24 weeks)
研究者
Antonio Hardan
Professor of Psychiatry and Behavioral Sciences
Stanford University