Autism Spectrum DisordersNCT06147141
Effectiveness and Mechanism of Online Peer Companion Intervention on Children With Autism Spectrum Disorders
A study testing Online Peer Companion Intervention and Wait-List in people with Autism Spectrum Disorders, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Online Peer Companion Intervention and Wait-List
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University
Beijing, Beijing Municipality, 100871
Yinyin Zang, +86-10-62756953, yinyin.zang@pku.edu.cn
Yinyin Zang
About this study
Official title: 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:
- Whether OPCI is effective on the social abilities and mental health of ASD children;
- What impact does OPCI have on the social abilities and mental health of ordinary children;
- What impact does OPCI have on the mental health of both children's parents;
- What are the mechanisms of OPCI on ASD children.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Online Peer Companion Intervention, Wait-List
- Keywords
- Autism Spectrum Disorders, Peer-Mediated Intervention, Children
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Peer Companion InterventionBehavioural
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-ListBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online Peer Companion Intervention group (OPCI) | Experimental | experimental group Receives: Behavioral: Online Peer Companion Intervention |
| Wait-List Group (WLG) | Placebo comparator | control group Receives: Behavioral: Wait-List |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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
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.
Measured: 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
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)
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start15 Nov 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Online Peer Companion Intervention group (OPCI) and Wait-List Group (WLG)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YinyinZang, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147141
- Sponsor's protocol ID
- OPCI on Children with ASD
- Status last verified
- Apr 2024
- First submitted
- 19 Nov 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Mechanism of Online Peer Companion Intervention on Children With Autism Spectrum Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06147141
- Acronym / sponsor ID
- OPCI on Children with ASD
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism Spectrum Disorders, Peer-Mediated Intervention, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether OPCI is effective on the social abilities and mental health of ASD children;
- What impact does OPCI have on the social abilities and mental health of ordinary children;
- What impact does OPCI have on the mental health of both children's parents;
- What are the mechanisms of OPCI on ASD children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Online Peer Companion Intervention group (OPCI) and Wait-List Group (WLG)
| Arm | Type | Receives |
|---|---|---|
| Online Peer Companion Intervention group (OPCI) | Experimental | Behavioral: Online Peer Companion Interventionexperimental group |
| Wait-List Group (WLG) | Placebo comparator | Behavioral: Wait-Listcontrol group |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Peer Companion InterventionOrdinary 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. | Behavioural | Online Peer Companion Intervention group (OPCI) |
| Wait-ListDyads 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. | Behavioural | Wait-List Group (WLG) |
Primary outcome
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).
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)
3 secondary outcomes
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
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Peer Companion Intervention and Wait-List in people with Autism Spectrum Disorders, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yinyin Zang, PhD (010-62756953, Yinyin.Zang@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.