Clinical trial NCT06421272: APP-based Emotion Recognition Training Improve ASD Social Function
Official title: APP-based Emotion Recognition Training Improve ASD Social Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Autism Spectrum Disorder High-Functioning
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group (emotion recognition); control group (memory training)
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ADOS-2 assessment
timeFrame: 1-2 hour
measure: SRS-2
timeFrame: half an hour
Secondary outcomes:
measure: Visual performance across five tasks based on eye-tracking
timeFrame: half an hour
Other outcomes:
measure: Other questionnaires and assessment
timeFrame: 1-2 hour
measure: Other questionnaires and assessment
timeFrame: 1-2 hour
measure: Other questionnaires and assessment
timeFrame: 1-2 hour
measure: Other questionnaires and assessment
timeFrame: 1-2 hour
measure: Other questionnaires and assessment
timeFrame: 1-2 hour
Locations:
city: Chendu
country: China
facility: University of Electronic Science and Technology
state: Sichuan
Study officials:
References: