- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06421272
APP-based Emotion Recognition Training Improve ASD Social Function
May 16, 2024 updated by: Weihua Zhao, University of Electronic Science and Technology of China
The main aim of the study is to investigate whether APP-based emotional recognition training improve social function in autistic children.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
50 ASD children age ranged from 4-10 years old will be randomly allocated to either app-based emotional recognition training or memory training groups for 2 months.
Before and after training, some assessements were measured including Autism Diagnostic Observation Schedule-2, Childhood Autism Rating Scale, Wechsler Intelligence Scale and Psychoeducational Profile-3.
Some other questionnaires are also collected including Social Responsibility Scale-2,Repetitive behavior scale-Revised,Caregiver Strains Questionnaire,Social Communication Questionnaire,Social Anxiety Scale for Children,Adaptive behavior assessment Schedule.
Four eye-tracking tasks as follows: (1) Dynamic geometrical paired with dynamic child dancing; (2) Static neutral and emotional faces; (3) A dynamic gaze-following task; (4) social interaction behaviors paired with the toys alone; (5) spinning actions conducted via children paired with objects.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chendu, Sichuan, China, 611731
- Recruiting
- University of Electronic Science and Technology
-
Contact:
- Weihua Zhao, Phd
- Phone Number: +86 18780247797
- Email: zarazhao@uestc.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
- Child
Accepts Healthy Volunteers
No
Description
Inclusion criteria: Clinical diagnosis of Autism Spectrum Disorder and follow these criteria: (1) Age range: 4-10 years old, gender not limited;(2) Ethnicity: Han nationality;(3) Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) Comparison Score greater than or equal to 5 points (Le et al., 2022);(4) Considering that only high-functioning autism individuals can successfully complete the eye-tracking tasks, children with a Wechsler score greater than or equal to 60 points are selected; Exclusion criteria: (1) No neurological complications, such as epilepsy, cerebral palsy, fragile X syndrome, etc.;(2)
No prior medical interventions, such as taking antipsychotic drugs, receiving transcranial magnetic stimulation, acupuncture, etc.;(3)
No abnormal imaging diagnosis or any brain injury.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: APP-based emotion recognition trainning
Experimental group: ASD children were asked to do emotion recognition for eight weeks using iPAD.
Two 15-minsute sessions each day was required.
|
ASD children were asked to play emotion recognition-related games for eight weeks using iPAD.
Two 15-minsute sessions each day was required.
|
Active Comparator: APP-based memory training
Control group: ASD children were asked to do memory training (i.e. 1 back) for eight weeks using iPAD.
Two 15-minsute sessions each day was required.
|
ASD children were asked to play memory-related games for eight weeks using iPAD.
Two 15-minsute sessions each day was required.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADOS-2 assessment
Time Frame: 1-2 hour
|
ADOS-2 assessment
|
1-2 hour
|
SRS-2
Time Frame: half an hour
|
SRS-2
|
half an hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual performance across five tasks based on eye-tracking
Time Frame: half an hour
|
Tasked based eye-tracking performance including fixation time, fixation counts
|
half an hour
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other questionnaires and assessment
Time Frame: 1-2 hour
|
CARS
|
1-2 hour
|
Other questionnaires and assessment
Time Frame: 1-2 hour
|
PEP-3
|
1-2 hour
|
Other questionnaires and assessment
Time Frame: 1-2 hour
|
RBS-R
|
1-2 hour
|
Other questionnaires and assessment
Time Frame: 1-2 hour
|
SCQ
|
1-2 hour
|
Other questionnaires and assessment
Time Frame: 1-2 hour
|
CSQ
|
1-2 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
January 1, 2023
Primary Completion (Estimated)
May 31, 2024
Study Completion (Estimated)
May 31, 2024
Study Registration Dates
First Submitted
May 7, 2024
First Submitted That Met QC Criteria
May 16, 2024
First Posted (Actual)
May 20, 2024
Study Record Updates
Last Update Posted (Actual)
May 20, 2024
Last Update Submitted That Met QC Criteria
May 16, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-94
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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