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临床试验/NCT06147141
NCT06147141Unknown不适用

Effectiveness and Mechanism of Online Peer Companion Intervention on Children With Autism Spectrum Disorders: A Randomized Controlled Trial

Peking University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Mental Health of ASD Children

研究概览

简要总结

The goal of this interventional study was to examine the effectiveness and mechanism of online peer companion intervention (OPCI) on the social abilities and mental health of ASD children. The main questions it aims to answer are:

  1. Whether OPCI is effective on the social abilities and mental health of ASD children;
  2. What impact does OPCI have on the social abilities and mental health of ordinary children;
  3. What impact does OPCI have on the mental health of both children's parents;
  4. What are the mechanisms of OPCI on ASD children.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • of ASD Children:
  • 7-15 years old and diagnosed as mild ASD;
  • Basic ability to speak independently and fluently communicate with peers;
  • Could use mobile phones, tablets, computers, or other electronic devices for this online intervention.

排除标准

  • of ASD Children:
  • Diagnosed as moderate or severe ASD;
  • Unable or unwilling to communicate with peers independently
  • No phones or other alternative electronic devices for the intervention Inclusion
  • Criteria of Ordinary Children:
  • 9-18 years old with normal development, no diagnosis of ASD, learning disabilities, ADHD, and other mental disorders;
  • Lively and outgoing, able to assume the role of topic organizer in communication with peers;
  • Could use mobile phones, tablets, computers, or other electronic devices for this online intervention.
  • Exclusion Criteria of Ordinary Children
  • Diagnosis of ASD or other neurodevelopmental and mental disorders;
  • Introverted or unwilling to play with peer ASD children
  • No phones or other alternative electronic devices for the intervention

结局指标

主要结局

Mental Health of ASD Children

时间窗: Pre-test, two process measurements (after 6th and 9th session, respectively), post-test, and follow-up (1, 2, 3 and 6 months after the intervention

We examined the effectiveness of OPCI on the mental health of ASD participants through the parent-report 25-item Revised Child Anxiety and Depression Scale (RCADS)

Social Behavior of ASD Children

时间窗: Pre-test, two process measurements (after 6th and 9th session, respectively), post-test, and follow-up (1, 2, 3 and 6 months after the intervention

We examined the effectiveness of OPCI on the social behavior of ASD participants through parent-report Social Responsiveness Scale (SRS).

次要结局

  • Social Ability of Ordinary Children(Pre-test, two process measurements (after 6th and 9th session, respectively), post-test, and follow-up (1, 2, 3 and 6 months after the intervention)
  • Mental Health of Ordinary Children(Pre-test, two process measurements (after 6th and 9th session, respectively), post-test, and follow-up (1, 2, 3 and 6 months after the intervention) or only measure at pre-test, post-test and follow-up)
  • Mental Health of Parents(Pre-test, two process measurements (after 6th and 9th session, respectively), post-test, and follow-up (1, 2, 3 and 6 months after the intervention) or only measure at pre-test, post-test and follow-up.)

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

YinyinZang

School of Psychological and Cognitive Sciences

Peking University

研究点 (1)

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