NCT06262230

Brief Summary

The goal of this interventional study was to explore the feasibility and effectiveness 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.What is the acceptability and adherence of OPCI;
  2. 2.Whether OPCI is effective on the social abilities and mental health of ASD children;
  3. 3.What impact does OPCI have on ordinary children and parents of both children?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

November 20, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

November 12, 2022

Last Update Submit

February 8, 2024

Conditions

Keywords

Autism Spectrum DisorderPeer-Mediated Intervention

Outcome Measures

Primary Outcomes (4)

  • Social Behavior of ASD Children

    We explored the effectiveness of OPCI on the social behavior of ASD participants through some parent-report scales, including the Social Responsiveness Scale (SRS) and the Strengths and Difficulties Questionnaire (SDQ).

    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 explored 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)

  • 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

  • Symptom Severity

    We explored the effectiveness of OPCI on the ASD symptoms through the Autism Behavior Checklist (ABC), which is a parent-report scale

    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.

Study Arms (1)

paired ASD and ordinary children

EXPERIMENTAL

In this prevent study, ordinary children will be paired with children with ASD based on ages, hobbies, and other aspects.

Behavioral: Online Inclusive Companionship Intervention

Interventions

After prior intervention, professionals will conduct a lecture for ordinary children, which includes basic knowledge of ASD and communication skills with ASD children. These ordinary children will be paired with ASD children then. The entire intervention including 12 sessions will last for 3 months. Researchers will prepare a series of themes that the ASD children could choose, and the ordinary children need to ask their paired ASD children what activities they want to choose before each session. Then, they will carry out this entertainment online together through Tencent WeMeet. A researcher will supervise online at the same time and record the communication through instant video. The Researcher will turn off the video and sound throughout the process and will not intervene in the conversation between the ASD children and ordinary children except for special circumstances.

paired ASD and ordinary children

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (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
  • No phones or other alternative electronic devices for the intervention
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

Location

Related Publications (3)

  • Chen YL, Schneider M, Patten K. Exploring interpersonal and environmental factors of autistic adolescents' peer engagement in integrated education. Autism. 2022 Jul;26(5):1255-1266. doi: 10.1177/13623613211046158. Epub 2021 Sep 18.

    PMID: 34541934BACKGROUND
  • Zercher C, Hunt P, Schuler A, Webster J. Increasing joint attention, play and language through peer supported play. Autism. 2001 Dec;5(4):374-98. doi: 10.1177/1362361301005004004.

  • Jones, V. (2007). 'I felt like I did something good'-The impact on mainstream pupils of a peer tutoring programme for children with autism. British Journal of Special Education, 34(1), 3-9. https://doi.org/10.1111/j.1467-8578.2007.00447.x

    RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: In this study, ordinary children will be paired with ASD children according to age, hobbies and other conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2022

First Posted

February 15, 2024

Study Start

November 20, 2022

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Since this study would include ASD children, we didn't plan to share IPD to protect the participants in this study

Locations