A superiority, confirmatory clinical trial to assess the efficacy of cognitive therapy software ‘NDTx-01’ in patients with autism spectrum disorder (ASD) or social communication disorders (SCD)

Not Applicable

Recruiting

Conditions: Mental and behavioural disorders

Registration Number: KCT0009699

Lead Sponsor: eudive Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

•Children and adolescents between the ages of 10 and 18
•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
•Participants who are able to install ‘NDTx-01’ on an Android smartphone and use it alone or with the help of their guardian
•Participants who are able to comply with the recommended application time for the investigational medical device (6 weeks, 30 times, 5 times a week)
•Participants who have agreed not to use any other medical devices besides the investigational medical device during the clinical trial
•Participants who agree that there should be no change in the use of drugs which can significantly affect one’s sociality during the clinical trial (If there is a drug being taken during screening, it can be taken continuously, but the total daily dose, ingredients, etc., should remain unchanged until the end of the study visit.)
•Participants who agree not to participate in other Applied Behavior Analysis (ABA) treatment/rehabilitation/education, social treatment/rehabilitation/education program (If there is treatment/rehabilitation/education being received during screening, it can be received continuously, but the number of applications and treatment methods should remain unchanged until the end of the study visit.)
•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
•Participants willing to comply with the clinical trial procedures

Exclusion Criteria

•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
•Severe acute/chronic medical or mental illness
•Serious trauma or surgery performed within 4 weeks before the screening date
•Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.)
•Participants who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening date
•Participants with a previous history of using NDTx-01, the investigational device
•Participants who have a change in the usage or dosage of drugs which can significantly affect one’s sociality, or a change in participation in treatment/rehabilitation/education programs that can significantly affect one’s sociality within 8 weeks before the baseline date of the clinical trial
•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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-?)

Secondary Outcome Measures

Name	Time	Method
Korean Vineland Adaptive Behavior Scales-?, K-VABS-II;Korean Social Responsiveness Scale-2, SRS-2;Korean Parenting Relationship Questionnaire – Child & Adolescent, K-PRQ-CA;Korean Inventory of Peer Relationships, KIPR;EuroQol Five Dimension Five Level Scale, EQ-5D-5L;Clinical Global Impression-Severity, CGI-S;Clinical Global Impression-Improvement, CGI-I;NDTx-01 Satisfaction Questionnaire;Adverse events