Effectiveness of a Developmental Reciprocity Treatment Program in Autism
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
研究概览
简要总结
This is a research study examining the effectiveness of a Developmental Reciprocity Treatment Program (DRT-P) in treating social deficits in children with Autism Spectrum Disorders (ASD). Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.
Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement DRP with in-home, therapist-implemented treatment. To determine the effectiveness of the DRT-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 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 based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), DSM-5, and expert clinical opinion;
- •Males and females in good medical health between 2.0 and 5 years 11 months;
- •Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;
- •Stable treatment (e.g., applied behavior analysis), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation;
- •Availability of at least one English-speaking parent who can consistently participate in parent training and research measures;
- •Clinical Global Impression(CGI) Severity Social Interaction and Communication Integrated Subscale ≥4;
- •Meet the cutoff for Autism on the ADOS-2.
排除标准
- •Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
- •A well-established genetic syndrome, such as Fragile X;
- •Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
- •Child's primary language other than English;
- •Previous adequate trial or training of a developmentally based intervention;
- •Participants living more than 45 miles from Stanford University;
- •Children with more than 20 hours of in-home ABA;
- •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 on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
时间窗: Baseline, 6, 12, and 24 weeks
Change from Baseline on the Brief Observation of Social Communication Change (BOSCC) at 24 weeks
时间窗: Baseline and 24 weeks
次要结局
- Change from Baseline on the Stanford Social Dimensions Scale (SSDS) Questionnaire.(Baseline, 12, and 24 weeks)
- Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 12, and 24 weeks(Baseline, 12, and 24 weeks)
研究者
Antonio Hardan
Professor of Psychiatry and Behavioral Sciences
Stanford University