To Evaluate the Efficacy and Safety of 'NDTx-01' in Patients With ASD or SCD

Launched by NEUDIVE INC. · May 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new cognitive therapy software called 'NDTx-01' to see if it works better than standard treatment for children and teenagers with Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD). The goal is to find out if using this software can help improve social skills and communication for these young people. The trial is currently looking for participants aged 10 to 18 who have been diagnosed with either ASD or SCD by a psychiatrist.

To be eligible for the study, participants need to be able to use an Android smartphone to install the software and follow a schedule of using it for six weeks, five times a week. They must also agree not to use other medical devices or change their medication during the trial. Additionally, participants and their parents must provide written consent to take part. This study will help researchers understand how effective 'NDTx-01' is in improving social communication skills, which could benefit many families dealing with these conditions.

Gender

ALL

Eligibility criteria

• 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

Trial Officials