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临床试验/NCT03177525
NCT03177525已完成不适用

Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder

Stanford University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Change in Visual Analog Scale Rating from Baseline to Week 12

研究概览

简要总结

Children with autism spectrum disorder (ASD) exhibit characteristic deficits in social initiation and there are no empirically validated treatments specifically for this core deficit. While parent training is known to be a critical intervention component, few social skills programs involve parents. This study will capitalize on an existing social skills group already established at the community agency Abilities United, with the goal of enhancing the program's effectiveness by adding a parent component. Specifically, the proposed study will investigate whether a novel parent mediated social skills program (Social SUCCESS), which provides parent training in conjunction with a social skills group intervention, will result in more frequent initiations during play with typically developing peers. Participants will include 50 children with ASD age 4:0 to 6:11 years. Children will be randomly assigned to either Social SUCCESS (N=25) or waiting list (N=25). Treatment will be provided for 8 weeks during a weekly 120-minute social skills group at Abilities United. The study will evaluate the effects of Social SUCCESS on areas of core social deficit including frequency of peer initiations using parent ratings, observational measures, standardized questionnaires, and a social eye tracking task. Outcomes will be compared to a waiting list control group. Findings will be disseminated through presentations and publications to aid clinicians in providing more effective social skills treatment for children with ASD and to enhance the scientific knowledge-base related to evidence-based social skills treatments. This research designed with the goal of stimulating additional scientific inquiry in the area of treatment for core social deficits in ASD and will provide a strong foundation for larger scale grants to study motivation-based interventions to improve social functioning.

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 (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • child aged 4.0 to 6.11 years
  • child diagnosed with ASD (Autism Diagnostic Observation Schedule; ADOS-2)
  • child without intellectual disability (Stanford Binet Intelligence Scales; SB-5)
  • parent able to consistently participate in parent training sessions and complete study measures

排除标准

  • child with other severe psychiatric disorder
  • child with known genetic condition (e.g., Fragile X, Retts)
  • child with unstable medical condition (e.g., active seizures)

结局指标

主要结局

Change in Visual Analog Scale Rating from Baseline to Week 12

时间窗: Baseline, Week 12

Parent rating on a Visual Analog Scale (VAS) of the child's frequency of initiation will be compared between Baseline and Week 12 to evaluate change

次要结局

  • Change in parent fidelity of implementation(Baseline, Week 12)
  • Social Responsiveness Scale, Second Edition(Baseline, Week 12, 3-month Follow-up)
  • Social Skills Improvement System(Baseline, Week 12, 3-month Follow-up)
  • Change in frequency of child initiations(Baseline, Week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Grace Gengoux

Clinical Associate Professor

Stanford University

研究点 (2)

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