None listed
Conditions
Interventions
Medical Device : Study group: NDTx-01 (5 times a week, for 6 weeks, 30 sessions in total)
Control group: Usual care*
*Usual care: Autism Spectrum Disorders(ASD) or Social Communication Disorders(SCD)-
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adolescents between the ages of 10 and 18 2. Diagnosed with autism spectrum disorder (ASD) or social communication disorder (SCD) based on the clinical judgment of a psychiatrist according to DSM-5 diagnostic criteria 3. Participants who are able to install ‘NDTx-01’ on an Android smartphone and use it alone or with the help of their guardian 4. Participants who are able to comply with the recommended application time for the investigational medical device (6 weeks, 30 times, 5 times a week) 5. Participants who have agreed not to use any other medical devices besides the investigational medical device during the clinical trial 6. Participants who agree not to participate in other Applied Behavior Analysis (ABA) treatment/education/rehabilitation, social treatment/education/rehabilitation program (Usual care that participants have been receiving can be continued) 7. Participants who and whose parents (legal guardians) have volunteered to participate in this clinical trial and have given written consent to the subject description and consent form 8. Participants willing to comply with the clinical trial procedures
Exclusion criteria
Exclusion criteria: 1. A risk of clinically significant behavioral problems, emotion regulation problems, psychotic symptoms, self-harm, or other harm at a level that affects the treatment process 2. Severe acute/chronic medical or mental illness 3. Serious trauma or surgery performed within 1 month 4. Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.) 5. Participants who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening date 6. Participants who have a change in the usage or dosage of drugs which can significantly affect one’s sociality among the drugs taken 4 weeks before the start date of the clinical trial, or a change in participation in treatment/education/rehabilitation programs that can significantly affect one’s sociality 7. In other cases where the investigator determines that participation in the clinical trial is inappropriate due to ethical reasons or the possibility of influencing the results of the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Korean Vineland Adaptive Behavior Scales-?, K-VABS-II;Korean Social Responsiveness Scale-2, SRS-2;Korean Version of Social Skill Rating System, K-SSRS;Revised Children’s Manifest Anxiety Scale, 2nd Edition, RCMAS-2;Korean version of Social communication questionnaire, K-SCQ;Korean Stress Index for Parents of Adolescents, K-SIPA;Clinical Global Impression-Severity, CGI-S;Clinical Global Impression-Improvement, CGI-I;Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactJoon Ho Lee
Samsung Medical Center
Outcome results
None listed