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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06421272
Other study ID # UESTC-neuSCAN-94
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 1, 2023
Est. completion date May 31, 2024

Study information

Verified date May 2024
Source University of Electronic Science and Technology of China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aim of the study is to investigate whether APP-based emotional recognition training improve social function in autistic children.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
APP-based emotion recognition intervention
ASD children were asked to play emotion recognition-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required.
APP-based memory intervention
ASD children were asked to play memory-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required.

Locations

Country Name City State
China University of Electronic Science and Technology Chendu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Other questionnaires and assessment CARS 1-2 hour
Other Other questionnaires and assessment PEP-3 1-2 hour
Other Other questionnaires and assessment RBS-R 1-2 hour
Other Other questionnaires and assessment SCQ 1-2 hour
Other Other questionnaires and assessment CSQ 1-2 hour
Primary ADOS-2 assessment ADOS-2 assessment 1-2 hour
Primary SRS-2 SRS-2 half an hour
Secondary Visual performance across five tasks based on eye-tracking Tasked based eye-tracking performance including fixation time, fixation counts half an hour
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