NCT06421272

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

May 7, 2024

Last Update Submit

May 16, 2024

Conditions

Autism Spectrum Disorder High-Functioning

Outcome Measures

Primary Outcomes (2)

  • ADOS-2 assessment

    ADOS-2 assessment

    1-2 hour

  • SRS-2

    SRS-2

    half an hour

Secondary Outcomes (1)

  • Visual performance across five tasks based on eye-tracking

    half an hour

Other Outcomes (5)

  • Other questionnaires and assessment

    1-2 hour

  • Other questionnaires and assessment

    1-2 hour

  • Other questionnaires and assessment

    1-2 hour

  • +2 more other outcomes

Study Arms (2)

APP-based emotion recognition trainning

EXPERIMENTAL

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

Behavioral: APP-based emotion recognition intervention

APP-based memory training

ACTIVE COMPARATOR

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.

Behavioral: APP-based memory intervention

Interventions

APP-based emotion recognition interventionBEHAVIORAL

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 emotion recognition trainning
APP-based memory interventionBEHAVIORAL

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

APP-based memory training

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology

Chengdu, Sichuan, 611731, China

RECRUITING

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental group (emotion recognition); control group (memory training)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 20, 2024

Study Start

January 1, 2023

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

May 20, 2024

Record last verified: 2024-05

Locations

CN(1)