None listed
Conditions
Interventions
Others(Digital Therapeutic Device) : 1. Investigational Device: Cognitive Therapy Software for ASD Treatment
- Theoretical Module: Educational content on the fundamentals of Applied Behavior Analysis
Sponsors
Chungbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Children aged 5 years or older and under 16 years at the time of assessment. 2) Children who meet clinical criteria consistent with Autism Spectrum Disorder (ASD) based on the DSM-5, and have a result from an ASD screening or a clinical evaluation indicating ASD. 3) A legally authorized representative (aged 19 years or older) is able to communicate adequately with the investigator, agrees to the study procedures as described in the protocol, and voluntarily signs the informed consent form after receiving and understanding sufficient information about the purpose and procedures of the study. 4) The caregiver has no difficulty using a smartphone application.
Exclusion criteria
Exclusion criteria: 1) Children with a history of uncontrolled seizure disorders or other neurological conditions, as determined by the clinical investigators. 2) Children with uncorrected sensory impairments (e.g., vision or hearing problems). 3) Children who have experienced changes in the type or frequency of non-pharmacological therapies within the past month - Including all cognitive-behavioral therapies, such as those related to Autism Spectrum Disorder. 4) Children who are currently participating in another interventional clinical trial or who have completed another interventional clinical trial within the past month. 5) Children who have had changes in the type or dosage of medications related to the indication of this clinical trial within the past two weeks. 6) Cases where the caregiver does not own a smartphone or is unable to use a smartphone application. 7) If the participant or their legally authorized representative does not consent to the study or withdraws consent during the course of the study. 8) Any other case in which the investigator deems the subject unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| K-CBCL;K-Vineland-I;SRS-2;K-CSCB;K-PSI-4-SF(age: 5-12) or K-SIPA(age:13-15);User satisfaction | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety outcome - Adverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactJungwoo Son
Chungbuk National University Hospital
Outcome results
None listed