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Effect and Mechanism of Social Interaction Treatment on ASD Children

NCT ID: NCT04327648

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-12-30

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.

Conditions

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ASD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Social interaction treatment

Intervention Type DEVICE

Children in social interaction treatment group will have 30min social interaction each day for 3 months.

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.

Group Type SHAM_COMPARATOR

Neuronal cognition treatment

Intervention Type DEVICE

Children in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months.

Routine treatment

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

Group Type OTHER

Routine treatment

Intervention Type OTHER

Children in routine treatment group will keep the same initial treatment.

Interventions

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Social interaction treatment

Children in social interaction treatment group will have 30min social interaction each day for 3 months.

Intervention Type DEVICE

Neuronal cognition treatment

Children in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months.

Intervention Type DEVICE

Routine treatment

Children in routine treatment group will keep the same initial treatment.

Intervention Type OTHER

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fei Li

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Central Contacts

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Fei Li

Role: CONTACT

Phone: +86-21-25077461

Email: [email protected]

Other Identifiers

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XH-20-004

Identifier Type: -

Identifier Source: org_study_id