Autism Spectrum DisorderNCT06262230
Feasibility and Effectiveness of OPCI on ASD Children
A study testing Online Inclusive Companionship Intervention in people with Autism Spectrum Disorder, run by Peking University at 1 site in China.
Trial 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. What is the acceptability and adherence of OPCI; 2. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Online Inclusive Companionship Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2022to 31 Oct 2023
- 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
- Healthy volunteers accepted
- 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.
- 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.
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
- 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.
About this study
Official title: 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:
- What is the acceptability and adherence of OPCI;
- Whether OPCI is effective on the social abilities and mental health of ASD children;
- What impact does OPCI have on ordinary children and parents of both children?
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Online Inclusive Companionship Intervention
- Keywords
- Autism Spectrum Disorder, Peer-Mediated Intervention
- 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 Inclusive Companionship InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online Inclusive Companionship Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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 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).
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)
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.
Measured: 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
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 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.
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 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.
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 posted15 Feb 2024
- Study start20 Nov 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this study, ordinary children will be paired with ASD children according to age, hobbies and other conditions
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
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
- NCT06262230
- Sponsor's protocol ID
- OPCI on ASD Children
- Status last verified
- Feb 2024
- First submitted
- 12 Nov 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this study would include ASD children, we didn't plan to share IPD to protect the participants in this study
Publications
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.
PubMed 34541934Zercher 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.
PubMed 11777255Jones, 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Online Peer Companion Intervention on Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06262230
- Acronym / sponsor ID
- OPCI on ASD Children
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Peer-Mediated Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 15 Feb 2024 (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 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:
- What is the acceptability and adherence of OPCI;
- Whether OPCI is effective on the social abilities and mental health of ASD children;
- What impact does OPCI have on ordinary children and parents of both children?
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this study, ordinary children will be paired with ASD children according to age, hobbies and other conditions
| Arm | Type | Receives |
|---|---|---|
| paired ASD and ordinary children | Experimental | Behavioral: Online Inclusive Companionship InterventionIn this prevent study, ordinary children will be paired with children with ASD based on ages, hobbies, and other aspects. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 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.
- 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;
Key exclusion criteria (6 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
- Diagnosis of ASD or other neurodevelopmental and mental disorders;
- Introverted or unwilling to play with peer ASD children
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 Inclusive Companionship InterventionAfter 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. | Behavioural | paired ASD and ordinary children |
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 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).
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).
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.
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
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 34541934Chen 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.
- Results publication: PubMed 11777255Zercher 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.
- Results publicationJones, 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
- Individual participant dataSharing planned: No. Since this study would include ASD children, we didn't plan to share IPD to protect the participants in this study
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inclusive Companionship Intervention in people with Autism Spectrum Disorder, 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 15 Feb 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06262230, which also lists 3 linked publications.
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 15 Feb 2024.