Effect and Mechanism of Social Interaction Treatment on ASD Children

Study Overview
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Brief Summary
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Current study try to find out whether social interaction treatment is effective for ASD children. ASD children will be divided into three groups, social interaction treatment group, neuronal cognition treatment and routine treatment group. Based on excited recognition training treatment effect on the core symptom of ADHD by tablet computer, the investigators propose that tablet computer social interaction treatment may induce a significant improvement in ameliorating the social disorder of ASD.

Detailed Description
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Appropriate and effective treatment coupled with home training can help ASD children restore the ability of language, behavior and learning. However, there is no suitable and effective behavior intervention for home training yet. Current study try a 3 months' randomized double-blinded clinical trial to find out whether tablet computer social interaction treatment at home is effective for ASD children. 90 3-6 years old ASD children will be included and divided into three groups, social interaction treatment group, neuronal cognition treatment and routine treatment group respectively. During the treatment days, children in social interaction treatment group will have 30min social interaction each day for 3 months. Children in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months. Children in routine treatment group will keep the same initial treatment. All ASD children are followed up closely. The primary observed indicator is the score of Childhood Autism Rating Scale (CARS) at the inclusion, one month and 3 month after treatment to evaluate the effect of tablet computer social interaction treatment on ASD children.

Official Title
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A Clinical Study to Explore the Effect and Mechanism of Social Interaction on Autism Spectrum Disorder Children: a Randomized Double-blinded Clinical Trial

Conditions
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ASD

Intervention / Treatment
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* Device: Social interaction treatment
* Device: Neuronal cognition treatment
* Other: Routine treatment


Participation Criteria
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Eligibility Criteria
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Inclusion criteria： Patients diagnosed with ASD. Diagnostic criteria: diagnosed by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R) CARS ≥ 34 Agree to sign the informed consent Exclusion criteria： Children with abnormal gene and chromosome Children with neurodevelopmental diseases (like epilepsy, schizophrenia) Children with severe sense perception disorder Children with weight over 20kg, with electronic metal products in body unsuited for magnetic resonance imaging

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Social interaction treatment<br>During the treatment days, children in social interaction treatment group will have 30min social interaction each day for 3 months. ASD children are followed up closely. | Device: Social interaction treatment<br>* Children in social interaction treatment group will have 30min social interaction each day for 3 months.<br>|
| Sham Comparator: Neuronal cognition treatment<br>Children in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months. ASD children are followed up closely. | Device: Neuronal cognition treatment<br>* Children in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months.<br>|
| Other: Routine treatment<br>Children in routine treatment group will keep the same initial treatment. ASD children are followed up closely. | Other: Routine treatment<br>* Children in routine treatment group will keep the same initial treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Childhood Autism Rating Scale, (CARS) | CARS is a behaviour-rating scale used to assess the presence and severity of the symptoms of autism spectrum disorder(ASD), with scores ranging from 15 to 60 and high scores indicating severe symptoms. Change of the CARS from baseline to 3 months after treatment to evaluate the effect of tablet computer social interaction treatment on ASD children. | The baseline and 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social responsiveness scale, (SRS) | SRS is a questionnaire used to assess the presence and severity of social impairment, with high scores indicating severe symptoms. Change of the SRS from baseline to 3 month after treatment to evaluate the effect of computer social interaction treatment on ASD children. | The baseline and 3 months after treatment | 
| Autism Diagnostic Observation Schedule, ADOS | The ADOS is a structured play session conducted by clinicians, with the total score combines the Social and Communication domain items, with high scores indicating severe symptoms. Change of the ADOS from baseline to 3 months after treatment to evaluate the effect of tablet computer social interaction treatment on ASD children. | The baseline and 3 months after treatment | 
| Clinical Global Impression, CGI | CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention | The baseline and 3 months after treatment |