Effect and Mechanism of Social Interaction Treatment on ASD Children

Not Applicable

• Conditions: ASD
• Interventions: Device: Neuronal cognition treatment; Device: Social interaction treatment; Other: Routine treatment

• Registration Number: NCT04327648
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-30
• Last Update Submitted: 2020-03-30
• Study First Posted: 2020-03-31
• Last Update Posted: 2020-03-31
• Study Start: 2020-06-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuronal cognition treatment	Neuronal cognition treatment	Children in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months. ASD children are followed up closely.
Social interaction treatment	Social interaction treatment	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.
Routine treatment	Routine treatment	Children in routine treatment group will keep the same initial treatment. ASD children are followed up closely.

Primary Outcome Measures

Name	Time	Method
Childhood Autism Rating Scale, (CARS)	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 Outcome Measures

Name	Time	Method
Social responsiveness scale, (SRS)	The baseline and 3 months after treatment	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.
Autism Diagnostic Observation Schedule, ADOS	The baseline and 3 months after treatment	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.
Clinical Global Impression, CGI	The baseline and 3 months after treatment	CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention