跳至主要内容
临床试验/NCT03785327
NCT03785327终止不适用

Improving Social Interaction for Adolescents With Autism During the Transition to Adulthood

The University of Texas at Dallas1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2019年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
78
试验地点
1
主要终点
Subjective Social Interaction Quality

研究概览

简要总结

This study compares the efficacy of two intervention strategies for improving social outcomes for autistic adolescents and young adults when interacting with unfamiliar non-autistic peers.

详细描述

Intellectually-capable older adolescents and young adults with autism spectrum disorder (ASD) often struggle to secure and maintain employment, succeed in college, or develop satisfying personal and professional relationships. Current psychosocial interventions for this population have produced limited effects on real-world functioning. These programs typically seek to improve social skill and understanding with the hope that these abilities will translate to better functioning and are often effective at increasing knowledge of social rules and norms,yet these improvements frequently do not translate to better social and life outcomes in the real world. One reason for their limited efficacy may be that the mechanisms involved in real-life social interaction continue to be poorly understood for this population. The current study is designed to specify the factors that predict more or less favorable social outcomes for autistic adolescents and young adults when interacting with an unfamiliar, non-autistic peer, and test a multifaceted intervention for improving these outcomes. The intervention will target both brain and behavior, not only in the individual with ASD but also in their typically-developing (TD) partners. For TD participants, the efficacy of a training program will be tested to determine if social experiences for older adolescents with ASD can be improved by increasing knowledge, acceptance, and understanding of autism among TD individuals. For the participants with ASD, this study will test the efficacy of an innovative, non-invasive neurostimulation session using Transcranial Direct Current Stimulation (tDCS) to target social brain regions involved in perspective-taking and social reciprocity. Social outcomes for each intervention will be compared to a "no intervention" control condition, and to each other, to provide a comprehensive examination of intrinsic and extrinsic factors contributing to social interaction quality for autistic adolescents and young adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 21 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Age: 18-21
  • •DSM-IV-TR or DSM-5 diagnosis of an Autism Spectrum Disorder

排除标准

  • •Presence or history intellectual impairment (defined as IQ <70)
  • •Presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or CNS tumors)
  • •Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment
  • •Not proficient in English
  • •Presence of substance abuse in the past one month
  • •Presence of substance dependence not in remission for the past six months
  • •Contraindications for tDCS (e.g., pregnancy or implanted devices such as pace maker)

研究组 & 干预措施

Active anodal tDCS

Experimental

Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS

干预措施: tDCS (Device)

Sham tDCS

Sham Comparator

Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS

干预措施: tDCS (Device)

Autism Training Program

Experimental

Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program

干预措施: Autism Training (Behavioral)

Social interaction without intervention

No Intervention

Control condition: Behavioral testing without an intervention component

结局指标

主要结局

Subjective Social Interaction Quality

时间窗: Interaction with unfamiliar partner occurs immediately following the autism training; self-report measure given immediately after the interaction, duration of completion averages around 2 minutes

Non-autistic participants social interest in autistic partners as measured by the First Impression Scale (Sasson et al., 2017). Four items, each scored on a Likert Scale from 1 to 4 in which higher values indicate greater social interest, are averaged to produce a social interest composite that serves as the primary outcome measure of the non-autistic participant's social interest in their autistic conversation partner.

次要结局

未报告次要终点

研究者

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

Noah Sasson

Associate Professor

The University of Texas at Dallas

研究点 (1)

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