A Study on the Effectiveness and Safety of a Digital Therapeutic Device for Improving Communication in Children with Autism

An explorative single-blind randomized clinical trial to evaluate the effectiveness and safety of the digital therapeutic for improving communication skills in children with autism spectrum disorder

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0011674

Enrollment

Registered

2026-03-04

Start date

2024-05-17

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : ? Clinical Trial Group: Application-based Therapy for Improving Communication in Children with ASD The clinical trial group received a tablet PC pre-installed with AVATA Cure (Play t

app version [AvataCure_v1.0.80.140]

operating system [Android 10]

device model [Samsung Galaxy Tab A 8.0]). AVATA Cure, developed by Play to Cure in collaboration with the speech-language pathology research team at Gachon University, is a portable app-based digital

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 1 to 7 years 2. A diagnosis of Autism Spectrum Disorder (ASD) based on DSM-5-TR criteria 3. Ability to use a tablet-based mobile application without difficulty

Exclusion criteria

Exclusion criteria: 1. Children with severe medical, sensory, or motor impairments 2. Children deemed unsuitable for participation in the clinical trial by the investigator for any other reason

Design outcomes

Primary

Measure	Time frame
Korean version of the Social Communication Questionnaire (K-SCQ);Korean Vineland Adaptive Behavior Scales, Second Edition (K-Vineland-II), Communication Domain;Sequenced Language Scale for Infants;Preschool Receptive-Expressive Language Scale	—

Secondary

Measure	Time frame
Childhood Autism Rating Scale, Korean version (K-CARS). In this study, only Item 7 (verbal communication) and Item 8 (non-verbal communication) were used.	—

Countries

Korea, Republic of

Contacts

Public ContactJisoo Lee

Bundang CHA General Hospital

leejisu7934@gmail.com+82-31-780-2966

Outcome results