Effect and Mechanism of Social Interaction Treatment on ASD Children

ASD Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04327648
• Other study ID #: XH-20-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2020
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Fei Li
• Phone: +86-21-25077461
• Email: feili[@]shsmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• ASD

Intervention

Device:
• Social interaction treatment
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.

Other:
• Routine treatment
Children in routine treatment group will keep the same initial treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Head magnetic resonance imaging (MRI)	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
Other	Head functional Near infra-red spectroscopy (fNIRs)	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
Primary	Childhood Autism Rating Scale, (CARS)	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	Social responsiveness scale, (SRS)	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
Secondary	Autism Diagnostic Observation Schedule, ADOS	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
Secondary	Clinical Global Impression, CGI	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