Effect and Mechanism of Social Interaction Treatment on ASD Children

Shanghai Jiao Tong University

Status: Unknown

Conditions: ASD

Treatments: Other: Routine treatment; Device: Social interaction treatment; Device: Neuronal cognition treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04327648

XH-20-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

Social interaction treatment

Active Comparator group

Description:

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.

Treatment:

Device: Social interaction treatment

Neuronal cognition treatment

Sham Comparator group

Description:

Children in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months. ASD children are followed up closely.

Treatment:

Device: Neuronal cognition treatment

Routine treatment

Other group

Description:

Children in routine treatment group will keep the same initial treatment. ASD children are followed up closely.

Treatment:

Other: Routine treatment