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

April 23, 2024 updated by: YinyinZang, Peking University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100871
        • Recruiting
        • Peking University
        • Contact:
        • Principal Investigator:
          • Yinyin Zang

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
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 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 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
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 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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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