Effectiveness and Mechanism of Online Peer Companion Intervention on Children With Autism Spectrum Disorders

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorders
• Intervention / Treatment: Behavioral: Online Peer Companion Intervention; Behavioral: Wait-List

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yinyin Zang, PhD; Phone Number: 010-62756953; Email: Yinyin.Zang@pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100871
      • Recruiting
      • Peking University
      • Contact: Yinyin Zang; Phone Number: +86-10-62756953; Email: yinyin.zang@pku.edu.cn
      • Principal Investigator: Yinyin Zang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria 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.

Exclusion Criteria 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online Peer Companion Intervention group (OPCI); experimental group	Behavioral: Online Peer Companion Intervention; Ordinary children would be paired with ASD children before the interventions. Dyads in the OPCI would have a total of 12 sessions within two months, each lasting 30-60 minutes. The longest interval between two sessions couldn't exceed two weeks. Researchers would recommend a series of companion themes for children to choose from (e.g., daily sharing and drawing). Ordinary children and ASD children need to discuss activities that are of mutual interest before each session. A researcher assistant would be online to ensure the normal development of the interventions and be responsible for video recording of the exchanges at the beginning of each session. Except for extreme circumstances, he or she would turn off the video and sound throughout the process and withdraw soon. During the interventions, parents would play a supporting role when children express needs without over-involvement.
Placebo Comparator: Wait-List Group (WLG); control group	Behavioral: Wait-List; Dyads in the WLG would only participate in preliminary training and measurement during the implementation of the intervention. After completing the post-test, this study will implement the same online peer companionship intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Behavior of ASD Children	We examined the effectiveness of OPCI on the social behavior of ASD participants through parent-report Social Responsiveness Scale (SRS).	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 ASD Children	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Health of Ordinary Children	We examined the effectiveness of OPCI on the mental health of ordinary children participants through some self-report and parent-report scales, including the 25-item Revised Child Anxiety and Depression Scale (RCADS), Connor-Davidson resilience scale (CD-RISC), and so on.	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
Social Ability of Ordinary Children	We explored the effectiveness of OPCI on the social ability of ordinary children participants through self-report and parent-report Social Skills Rating Systems (SSRS)	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 Parents	We examined the effectiveness of OPCI on the mental health of both children's parents through some self-report scales, including the General Anxiety Disorder Scale-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Connor-Davidson resilience scale (CD-RISC), and so on.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Process Screen Recording Coding	We coded the screen recording of interventions to explore the effectiveness and influencing factors of OPCI. Videos for each dyad will be conducted by a trained undergraduate student. This work will be carried out under the guidance and supervision of a professional clinical psychologist.	each session

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Children; Autism Spectrum Disorders; Peer-Mediated Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: OPCI on Children with ASD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No