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

Study Overview
=================
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: 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.

Official Title
-----------------
Effectiveness and Mechanism of Online Peer Companion Intervention on Children With Autism Spectrum Disorders: A Randomized Controlled Trial

Conditions
-----------------
Autism Spectrum Disorders

Intervention / Treatment
-----------------
* Behavioral: Online Peer Companion Intervention
* Behavioral: Wait-List


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Online Peer Companion Intervention group (OPCI) and Wait-List Group (WLG)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online Peer Companion Intervention group (OPCI)<br>experimental group | Behavioral: Online Peer Companion Intervention<br>* 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.<br>|
| Placebo Comparator: Wait-List Group (WLG)<br>control group | Behavioral: Wait-List<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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) | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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. | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism Spectrum Disorders, Peer-Mediated Intervention, Children