ASDNCT04327648
Effect and Mechanism of Social Interaction Treatment on ASD Children
A study testing Social interaction treatment, Neuronal cognition treatment and Routine treatment in people with ASD, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- ASD
- What is being tested?
- Social interaction treatment, Neuronal cognition treatment and Routine treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- ASD
- Being tested
- Social interaction treatment, Neuronal cognition treatment, Routine treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social interaction treatmentDevice
Children in social interaction treatment group will have 30min social interaction each day for 3 months.
Neuronal cognition treatmentDevice
Children in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months.
Routine treatmentOther
Children in routine treatment group will keep the same initial treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Neuronal cognition treatment |
| Routine treatment | Other | Children in routine treatment group will keep the same initial treatment. ASD children are followed up closely. Receives: Other: Routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The baseline and 3 months after treatment
Secondary outcomes (3)
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.
Measured: The baseline and 3 months after treatment
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.
Measured: The baseline and 3 months after treatment
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
Measured: The baseline and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Jun 2020 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASDStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Li, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327648
- Sponsor's protocol ID
- XH-20-004
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04327648
- Acronym / sponsor ID
- XH-20-004
- Conditions
- ASD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social interaction treatment | Active comparator | Device: Social interaction treatmentDuring 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. |
| Neuronal cognition treatment | Sham comparator | Device: Neuronal cognition treatmentChildren in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months. ASD children are followed up closely. |
| Routine treatment | Other | Other: Routine treatmentChildren in routine treatment group will keep the same initial treatment. ASD children are followed up closely. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social interaction treatmentChildren in social interaction treatment group will have 30min social interaction each day for 3 months. | Device | Social interaction treatment |
| Neuronal cognition treatmentChildren in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months. | Device | Neuronal cognition treatment |
| Routine treatmentChildren in routine treatment group will keep the same initial treatment. | Other | Routine treatment |
Primary outcome
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.
3 secondary outcomes
Social responsiveness scale, (SRS)
Time frame: The baseline and 3 months after treatment
Autism Diagnostic Observation Schedule, ADOS
Time frame: The baseline and 3 months after treatment
Clinical Global Impression, CGI
Time frame: The baseline and 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Li principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Social interaction treatment, Neuronal cognition treatment and Routine treatment in people with ASD, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Li (+86-21-25077461, feili@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Autism Rating Scale, (CARS) (time frame: The baseline and 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.