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

NCT06147141 | Recruiting DMC

• 1 other identifier: OPCI on Children with ASD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism Spectrum Disorders

Keywords

Autism Spectrum Disorders; Peer-Mediated Intervention; Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• 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 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.

Other Outcomes (1)

• Intervention Process Screen Recording Coding

  each session

Study Arms (2)

Online Peer Companion Intervention group (OPCI)

EXPERIMENTAL

experimental group

Behavioral: Online Peer Companion Intervention

Wait-List Group (WLG)

PLACEBO COMPARATOR

control group

Behavioral: Wait-List

Interventions

Online Peer Companion Intervention BEHAVIORAL

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.

Online Peer Companion Intervention group (OPCI)

Wait-List BEHAVIORAL

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.

Wait-List Group (WLG)

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosed as moderate or severe ASD;
• Unable or unwilling to communicate with peers independently
• Criteria of Ordinary Children:
• 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.
• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Central Study Contacts

Yinyin Zang, PhD

CONTACT

010-62756953; Yinyin.Zang@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: School of Psychological and Cognitive Sciences

Model Details: Online Peer Companion Intervention group (OPCI) and Wait-List Group (WLG)

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 27, 2023
• Study Start: November 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)