Clinical trial NCT04327648: Effect and Mechanism of Social Interaction Treatment on ASD Children
Official title: A Clinical Study to Explore the Effect and Mechanism of Social Interaction on Autism Spectrum Disorder Children: a Randomized Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ASD
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Childhood Autism Rating Scale, (CARS)
timeFrame: The baseline and 3 months after treatment
Secondary outcomes:
measure: Social responsiveness scale, (SRS)
timeFrame: The baseline and 3 months after treatment
measure: Autism Diagnostic Observation Schedule, ADOS
timeFrame: The baseline and 3 months after treatment
measure: Clinical Global Impression, CGI
timeFrame: The baseline and 3 months after treatment
Other outcomes:
measure: Head magnetic resonance imaging (MRI)
timeFrame: The baseline and 3 months after treatment
measure: Head functional Near infra-red spectroscopy (fNIRs)
timeFrame: The baseline and 3 months after treatment
Locations:
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Fei Li
role: PRINCIPAL_INVESTIGATOR
References: