NCT04327648

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

3.6 years

First QC Date

March 25, 2020

Last Update Submit

March 30, 2020

Conditions

ASD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Social responsiveness scale, (SRS)

    The baseline and 3 months after treatment

  • Autism Diagnostic Observation Schedule, ADOS

    The baseline and 3 months after treatment

  • Clinical Global Impression, CGI

    The baseline and 3 months after treatment

Other Outcomes (2)

  • Head magnetic resonance imaging (MRI)

    The baseline and 3 months after treatment

  • Head functional Near infra-red spectroscopy (fNIRs)

    The baseline and 3 months after treatment

Study Arms (3)

Social interaction treatment

ACTIVE COMPARATOR

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.

Device: Social interaction treatment

Neuronal cognition treatment

SHAM COMPARATOR

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

Device: Neuronal cognition treatment

Routine treatment

OTHER

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

Other: Routine treatment

Interventions

Social interaction treatmentDEVICE

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

Social interaction treatment
Neuronal cognition treatmentDEVICE

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

Neuronal cognition treatment
Routine treatmentOTHER

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

Routine treatment

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Fei Li

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Li

CONTACT

+86-21-25077461feili@shsmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 31, 2020

Study Start

June 1, 2020

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

March 31, 2020

Record last verified: 2020-03