Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- (Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)
研究概览
简要总结
The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD).
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
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of Autism Spectrum Disorder, higher functioning/low support needs
- •Intelligence Quotient (IQ): Participants with a Full Scale IQ > 80 on the Wechsler Abbreviated Scale of Intelligence (WASI-II)
- •Right-handed
- •No metal in their body/unremovable metal on their body (i.e., braces)
- •First language is English
- •Must live in the San Francisco Bay Area
- •Able and willing to receive intervention weekly for 9 weeks
- •Adolescent is interested in improving their social skills
- •MRI Compatibility: No major contraindication for MRI.
- •Diagnosis of ASD using ADOS-2 and ADI-R.
- •No evidence of a genetic, metabolic, or infectious etiology for their autism.
- •Primary diagnosis of ASD
- •No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.
- •Stable treatment (e.g., ABA), 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.
- •Score of at least 50% or below on at least 4 out of the 9 social target areas in the SLO (administered during pre-measures)
- •No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.
排除标准
- •History of claustrophobia, previous head injury, serious neurological or medical illness, birth weight less than 4 lb. and/or gestational age < 34 weeks
- •Left-handed
- •Braces or any metal in their body
结局指标
主要结局
(Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)
时间窗: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Target engagement consists of brain connectivity between voice selective superior temporal sulcus (STS) and the nucleus accumbens (NAc) of the mesolimbic reward system. For the PRT (i.e., intervention) group, brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model, a common measure of task-based brain connectivity using fMRI data. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and the NAc as the connectivity target region. Effect size will be computed using Cohen's d for a paired t-test comparing Post-Training and Pre-Training pSTS-NAc connectivity values (i.e., contrast betas): d = t/(sqrt(n) where t is the paired t-test and n the group size.
Change from baseline (Pre-training) in structured laboratory observations (SLO) of child-assessor interactions
时间窗: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
The Structured Laboratory Observations (SLO) of child-assessor interactions is a common behavioral measure of each participant's social communicative interactions assessed in a laboratory setting. The metric used to characterize the SLO is an overall percentage of appropriate social responsiveness. Change in baseline SLO will be computed by subtracting Post- from Pre-training percentage of appropriate social responsiveness for each participant in the PRT group.
次要结局
- (Secondary target) Change in brain connectivity between superior temporal sulcus (STS) and temporoparietal junction (TPJ)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)
- Association between change in target engagement and change in clinical benefit (STS and NAc)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)
- Group differences in the association between change in target engagement and clinical benefit (STS and NAc)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)
- Group differences in the association between change in target engagement and clinical benefit (STS and TPJ)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)
- Change in the Social Communication subscale of the Brief Observation of Social Communication Change (BOSCC)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)
- Association between change in target engagement and change in clinical benefit (STS and TPJ)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)
研究者
Daniel Abrams
Clinical Assistant Professor
Stanford University