## Protocol Section
### Identification Module
**NCT ID:** NCT06421272

**Brief Title:** APP-based Emotion Recognition Training Improve ASD Social Function

**Official Title:** APP-based Emotion Recognition Training Improve ASD Social Function

#### Organization Study ID Info
**ID:** UESTC-neuSCAN-94
#### Organization
**Class:** OTHER
**Full Name:** University of Electronic Science and Technology of China
### Status Module
#### Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Electronic Science and Technology of China

#### Responsible Party

**Investigator Affiliation:** University of Electronic Science and Technology of China

**Investigator Full Name:** Weihua Zhao

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Autism Spectrum Disorder High-Functioning

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Experimental group (emotion recognition); control group (memory training)

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Experimental group: ASD children were asked to do emotion recognition for eight weeks using iPAD. Two 15-minsute sessions each day was required.

**Intervention Names:**

- Behavioral: APP-based emotion recognition intervention

**Label:** APP-based emotion recognition trainning

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: APP-based memory intervention

**Label:** APP-based memory training

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- APP-based emotion recognition trainning

**Description:** ASD children were asked to play emotion recognition-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required.

**Name:** APP-based emotion recognition intervention

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- APP-based memory training

**Description:** ASD children were asked to play memory-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required.

**Name:** APP-based memory intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** CARS

**Measure:** Other questionnaires and assessment

**Time Frame:** 1-2 hour

**Description:** PEP-3

**Measure:** Other questionnaires and assessment

**Time Frame:** 1-2 hour

**Description:** RBS-R

**Measure:** Other questionnaires and assessment

**Time Frame:** 1-2 hour

**Description:** SCQ

**Measure:** Other questionnaires and assessment

**Time Frame:** 1-2 hour

**Description:** CSQ

**Measure:** Other questionnaires and assessment

**Time Frame:** 1-2 hour

#### Primary Outcomes

**Description:** ADOS-2 assessment

**Measure:** ADOS-2 assessment

**Time Frame:** 1-2 hour

**Description:** SRS-2

**Measure:** SRS-2

**Time Frame:** half an hour

#### Secondary Outcomes

**Description:** Tasked based eye-tracking performance including fixation time, fixation counts

**Measure:** Visual performance across five tasks based on eye-tracking

**Time Frame:** half an hour

### Eligibility Module

**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.

**Maximum Age:** 10 Years

**Minimum Age:** 4 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chendu

**Contacts:**

***Contact 1:***

- **Email:** zarazhao@uestc.edu.cn

- **Name:** Weihua Zhao, Phd

- **Phone:** +86 18780247797

- **Role:** CONTACT

**Country:** China

**Facility:** University of Electronic Science and Technology

**State:** Sichuan

**Status:** RECRUITING

**Zip:** 611731

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002659

- Term: Child Development Disorders, Pervasive

- ID: D000065886

- Term: Neurodevelopmental Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4623

- Name: Autistic Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M206

- Name: Autism Spectrum Disorder

- Relevance: HIGH

- As Found: Autism Spectrum Disorder

- ID: M5903

- Name: Child Development Disorders, Pervasive

- Relevance: LOW

- As Found: Unknown

- ID: M5902

- Name: Developmental Disabilities

- Relevance: LOW

- As Found: Unknown

- ID: M30644

- Name: Neurodevelopmental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000067877

- Term: Autism Spectrum Disorder

### Misc Info Module

- Version Holder: 2024-05-31
