A Clinical Study to Explore the Effect and Mechanism of Social Interaction on Autism Spectrum Disorder Children: a Randomized Double-blinded Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ASD
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 90
- Primary Endpoint
- Childhood Autism Rating Scale, (CARS)
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Childhood Autism Rating Scale, (CARS)
Time Frame: The baseline and 3 months after treatment
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.
Secondary Outcomes
- Social responsiveness scale, (SRS)(The baseline and 3 months after treatment)
- Autism Diagnostic Observation Schedule, ADOS(The baseline and 3 months after treatment)
- Clinical Global Impression, CGI(The baseline and 3 months after treatment)