- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04327648
Effect and Mechanism of Social Interaction Treatment on ASD Children
March 30, 2020 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
A Clinical Study to Explore the Effect and Mechanism of Social Interaction on Autism Spectrum Disorder Children: a Randomized Double-blinded Clinical Trial
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fei Li
- Phone Number: +86-21-25077461
- Email: feili@shsmu.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Children in social interaction treatment group will have 30min social interaction each day for 3 months.
|
Sham Comparator: 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.
|
Children in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months.
|
Other: Routine treatment
Children in routine treatment group will keep the same initial treatment.
ASD children are followed up closely.
|
Children in routine treatment group will keep the same initial treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The baseline and 3 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social responsiveness scale, (SRS)
Time Frame: 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.
|
The baseline and 3 months after treatment
|
Autism Diagnostic Observation Schedule, ADOS
Time Frame: 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.
|
The baseline and 3 months after treatment
|
Clinical Global Impression, CGI
Time Frame: 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
|
The baseline and 3 months after treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Head magnetic resonance imaging (MRI)
Time Frame: The baseline and 3 months after treatment
|
Head MRI is used to detect the structure and function of the brain.
Changes in the head MRI results of the subject before and after treatment.
|
The baseline and 3 months after treatment
|
Head functional Near infra-red spectroscopy (fNIRs)
Time Frame: The baseline and 3 months after treatment
|
Head fNIRs is a non-invasive, non-ionizing method for measuring and imaging the functional hemodynamic response to brain activity.
It measures changes in hemoglobin (Hb) concentrations within the brain by means of the characteristic absorption spectra of Hb in the near-infrared range.
Changes in the head fNIRs results of the subject before and after treatment.
|
The baseline and 3 months after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fei Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2020
Primary Completion (Anticipated)
December 30, 2023
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
March 25, 2020
First Submitted That Met QC Criteria
March 30, 2020
First Posted (Actual)
March 31, 2020
Study Record Updates
Last Update Posted (Actual)
March 31, 2020
Last Update Submitted That Met QC Criteria
March 30, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- XH-20-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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