Feasibility and Effectiveness of OPCI on ASD Children

February 8, 2024 updated by: YinyinZang, Peking University

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

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. What is the acceptability and adherence of OPCI;
  2. Whether OPCI is effective on the social abilities and mental health of ASD children;
  3. What impact does OPCI have on ordinary children and parents of both children?

Study Overview

Status

Completed

Detailed Description

Autism Spectrum Disorder (ASD), as defined by the Diagnostic and Statistical Manual Fifth Edition of the American Psychiatric Association (DSM 5), is a neurodevelopmental disorder associated with symptoms that include "persistent deficits in social communication and social interaction across multiple contexts" and "restricted, repetitive patterns of behavior, interests, or activities." The education of children with ASD is a critical topic that has attracted widespread attention around the world. The mainstream education model has gradually shifted from the traditional education that separates special groups from the general population to a new model named inclusive education. Inclusive education was formally proposed in the Salamanca Declaration promulgated by the World Conference on Education for All in 1994, which was organized by the United Nations Educational, Scientific and Cultural Organization. The so-called inclusive education is an educational concept of special education, which means that children with disabilities could enter common classes for non-differentiated learning through different levels of educational design and adjustment. However, due to problems such as teachers' competence and public awareness, it is difficult to popularize and popularize inclusive education in schools in China. According to the data of the "White Paper on the Investigation of Family Situation of Autism in China", although over 70% of the people said they were not afraid of contacting autistic patients, over 80% of the people said they would accept and help autistic patients. As a result of the insufficient understanding of autism, only about 10% of children with ASD could enter ordinary schools. Based on this actual condition, the inclusive education of ASD children in China is mainly led by social organizations and guides ordinary children and ASD children to carry out activities together by stimulating ordinary children's curiosity and sympathy for the population of ASD children.

The effectiveness of the inclusive education model through peer-to-peer entertainment has also received preliminary empirical support. A study by Zercher et al. (2001) showed that, after training, typically developing groups of children aged 5, 9, and 11 were able to effectively promote activities in comprehensive playgroups involving children with ASD, whereas During this process, the characteristics of children with ASD, such as attention and verbal expression, were significantly improved. The results also showed that such increases were maintained in the unassisted group. Some studies have also shown that this form of inclusive education not only has a significant effect on the improvement of symptoms of ASD children, but also has a positive impact on the mental health of ordinary children, and can improve their self-efficacy and life satisfaction.

In recent years, the COVID-19 epidemic has had a huge impact on the world. To ensure the safety and health of children, inclusive education cannot be carried out offline. Fortunately, online inclusive education has achieved initial development. Furthermore, the development of online inclusive education could balance the differences in mental health resources between different regions. However, the feasibility and effectiveness of online inclusive education have yet to be clarified. Based on this background, this study will take ASD children and ordinary children of the same age population as participants. this present study aims to preliminarily clarify the feasibility and effectiveness of one-to-one online communication and peer-to-peer entertainment.

This present study will explore the feasibility and effectiveness of online peer companion intervention (OPCI) for children with ASD. Compared to traditional offline education and interventions for ASD children, this online intervention has higher convenience and lower cost advantages. At the same time, OPCI is also conducive to balancing the differences in mental health resources, so that more children with ASD from underdeveloped regions could have better interventions. Furthermore, in addition to improving social skills and mental health, peer participation in OPCI has the potential to promote the development of the social networks of children with ASD.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100871
        • Peking University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: paired ASD and ordinary children
In this prevent study, ordinary children will be paired with children with ASD based on ages, hobbies, and other aspects.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Process Screen Recording Coding
Time Frame: each session
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
Social Behavior of ASD Children
Time Frame: 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 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
Time Frame: 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 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)
Symptom Severity
Time Frame: 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 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental Health of Ordinary Children
Time Frame: 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.
We explored 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), Perceived Stress Scale (PSS), Self Acceptance Questionnaire (SAQ), 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
Time Frame: 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 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
Time Frame: 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.
We explored 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), Perceived Stress Scale-4 (PSS-4), Self Acceptance Questionnaire (SAQ), 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2022

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

November 12, 2022

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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