Clinical trial NCT06147141: Effectiveness and Mechanism of Online Peer Companion Intervention on Children With Autism Spectrum Disorders
Official title: Effectiveness and Mechanism of Online Peer Companion Intervention on Children With Autism Spectrum Disorders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: Autism Spectrum Disorders
Peer-Mediated Intervention
Children
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Online Peer Companion Intervention group (OPCI) and Wait-List Group (WLG)
Primary purpose: TREATMENT

Brief 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. 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.


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
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:
measure: Intervention Process Screen Recording Coding
timeFrame: each session
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
References: