Clinical trial NCT06262230: Feasibility and Effectiveness of OPCI on ASD Children
Official title: Feasibility and Effectiveness of Online Peer Companion Intervention on Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Peer-Mediated Intervention
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this study, ordinary children will be paired with ASD children according to age, hobbies and other conditions
Primary purpose: SUPPORTIVE_CARE

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. 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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Social Behavior of ASD Children
timeFrame: 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)
measure: Mental Health of ASD Children
timeFrame: 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)
measure: Intervention Process Screen Recording Coding
timeFrame: each session
measure: Symptom Severity
timeFrame: 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:
measure: Mental Health of Ordinary Children
timeFrame: 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.
measure: Social Ability of Ordinary Children
timeFrame: 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)
measure: Mental Health of Parents
timeFrame: 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 outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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