Translating Neuroprediction Into Precision Medicine Via Brain Priming
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Social Responsiveness Scale, 2nd Edition (SRS-2)
研究概览
简要总结
The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT) on the development of language, social, and play skills in young children with Autism Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an enhancer of response to PRT. Participants will be randomly assigned to either an intranasal OXT group or a placebo group. Neither the research team nor the participants will know or choose which group the participant is assigned to. Children in both groups will participate in a 16-week trial of PRT. The trial will test the hypothesis that children with lower levels of activity in and functional connectivity among certain PRT-response brain regions will benefit more from the administration of OXT vs. placebo as an enhancer to a 16-week trial of PRT.
详细描述
This project investigates the effectiveness of a new intervention approach for Autism Spectrum Disorder (ASD) to optimize the effects of an evidence-based behavioral intervention, Pivotal Response Treatment (PRT) by attempting to enhance it with oxytocin (OXT). We will integrate fMRI, eye tracking, and behavioral outcomes to measure how OXT may create a neural background for individuals with ASD to bolster their motivation to interact socially and facilitate their biological preparedness for learning social communication skills during behavioral treatments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fit the age requirement: age 5-9
- •Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team
- •Be in good medical health
- •Be cooperative with testing
- •Speak English in the family
- •Successfully complete an fMRI scan
- •Full-scale intelligence quotient (IQ)>70
排除标准
- •Any metal or electromagnetic implants, including:
- •Cardiac pacemaker
- •Defibrillator
- •Artificial heart valve
- •Aneurysm clip
- •Cochlear implants
- •Neurostimulators
- •History of metal fragments in eyes or skin
- •Significant hearing loss or other severe sensory impairment
- •A fragile health status.
- •Current use of prescription psychotropic medications that may affect cognitive processes under study.
- •A history of significant head trauma or serious brain or psychiatric illness
研究组 & 干预措施
Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray
Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.
干预措施: Oxytocin (Drug)
Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray
Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.
干预措施: Pivotal Response Treatment (Behavioral)
Pivotal Response Treatment (PRT)/placebo nasal spray
Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.
干预措施: Pivotal Response Treatment (Behavioral)
Pivotal Response Treatment (PRT)/placebo nasal spray
Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.
干预措施: Placebo (Drug)
结局指标
主要结局
Social Responsiveness Scale, 2nd Edition (SRS-2)
时间窗: Change from Baseline to post-treatment, 16 weeks
The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 is filled out by a parent. The SRS-2 has a minimum raw score of 0 and a maximum raw score of 195. Higher raw scores on the SRS-2 mean a worse outcome.
次要结局
- Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III)(Change from Baseline to post-treatment, 16 weeks)