NCT03583684招募中不适用
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in Number of Child Utterances During a Structured Lab Observation (SLO)
研究概览
简要总结
Autism spectrum disorder (ASD) is a very heterogeneous disorder with limited empirically validated behavioral and biological interventions. The goal of this pilot investigation is to apply a biologically-based approach to identify predictors of treatment response in children with ASD who are receiving Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Specifically, the investigators propose to identify neuroimaging biomarkers of treatment response to a PRT program (PRT-P) targeting language deficits in young children with ASD who will be randomized to either PRT-P or to a delayed treatment group (DTG).
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 (Investigator)
入排标准
- 年龄范围
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Autism Spectrum Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) and/or Brief Observation of Symptoms of Autism (BOSA) and/or Childhood Autism Rating Scale- Second Edition (CARS-2).
- •Outpatients between 2.0 and 4.11 years of age of either gender,
- •Children of all cognitive levels will be included as long as they are able 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) [at least 1 standard deviation behind for children age 2 and 3 years; and 2 standard deviations behind for children age 4],
- •Stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,
- •Stable treatment [Applied Behavior Analysis (ABA), Floortime, or other interventions], speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation,
- •No more than 60 minutes of 1:1 speech therapy per week,
- •The child's exposure to the English language must be sufficient that administration of standardized tests in English is appropriate for measuring progress,
- •The availability of at least one parent who can consistently participate in the training sessions and related activities, and
- •Successful completion of baseline brain scan.
排除标准
- •Current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder),
- •Genetic abnormality (e.g., Fragile X)
- •Presence of active medical problem (e.g., unstable seizure disorder),
- •Receiving more than 15 hours of in home 1:1 Applied Behavior Analysis (ABA) per week
- •Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal), or
- •Previous adequate Pivotal Response Treatment (PRT) trial.
结局指标
主要结局
Change in Number of Child Utterances During a Structured Lab Observation (SLO)
时间窗: Baseline, 16 Weeks
次要结局
- Change on MacArthur-Bates Communication Development Inventory (CDI)(Baseline, 16 Weeks)
研究者
Antonio Hardan
Principal Investigator
Stanford University
研究点 (2)
Loading locations...
相似试验
已完成
早期 1 期
Study of Neuroimaging Biomarkers of Social Cognition Deficits in Adolescents (Age 13-17) With Autism Spectrum Disorder and Effects of GabapentinAutism Spectrum DisorderNCT03589898University of Massachusetts, Worcester19
已完成
不适用
Investigating Neuroimaging Endophenotypes for Autism Spectrum DisorderAutism Spectrum DisorderNCT02720588National Taiwan University Hospital90
进行中（未招募）
不适用
Radiomics of Autism Spectrum DisorderAutism Spectrum DisorderNCT05439954Qingling Chen230
招募中
不适用
Effectiveness of a Parent-mediated Intervention With PACT on Children With ASDAutism Spectrum DisorderNCT04244721Hôpital le Vinatier212
已完成
不适用
Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication in ASDAutistic DisorderNCT02444117University Hospital, Tours200