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

NCT ID: NCT06147141

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-12-31

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. 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.

Conditions

Autism Spectrum Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Online Peer Companion Intervention group (OPCI)

experimental group

Group Type: EXPERIMENTAL

Online Peer Companion Intervention

Intervention Type: 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.

Wait-List Group (WLG)

control group

Group Type: PLACEBO_COMPARATOR

Wait-List

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

YinyinZang

School of Psychological and Cognitive Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yinyin Zang, PhD

Role: CONTACT

Yinyin.Zang@pku.edu.cn

010-62756953

Facility Contacts

Yinyin Zang

Role: primary

yinyin.zang@pku.edu.cn

+86-10-62756953

Other Identifiers

OPCI on Children with ASD

Identifier Type: -

Identifier Source: org_study_id