Clinical trial NCT06446193: To Evaluate the Efficacy and Safety of 'NDTx-01' in Patients With ASD or SCD
Official title: A Multi-center, Randomized, Assessor-blind, Superiority, Confirmatory Clinical Trial to Assess Safety and Efficacy of Cognitive Therapy Software 'NDTx-01' for Improving Social Awareness and Interaction in Children and Adolescents With Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Social Communication Disorder
Keywords: autism spectrum disorder
social communication disorder
digital therapeutics
adolescents
social communication
social skills
social adaptation
autistic
cognitive behavior therapy
social stories
peer relationship
intervention
Lead sponsor: Neudive Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-06
Enrollment: 86
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the superiority of the treatment of cognitive therapy software 'NDTx-01' compared to TAU (Treatment-As-Usual).

Detailed description: This confirmatory clinical trial aims to demonstrate the superiority of 'NDTx-01' by comparing and evaluating the efficacy and safety of the experimental group applying 'NDTx-01' with TAU (Treatment-As-Usual) and the control group applying TAU only.

The study participants will be randomized in a 1:1 as experimental group and control group. The experimental group applies 'NDTx-01' 30 times for 6 weeks (5 times a week) with TAU and the control group gets TAU only. For the primary purpose, the change in the adaptive behavior combination (ABC) score of the Korean version of the Vineland Adaptive Behavior Scale-II (K-VABS-II) at 42 days compared to the baseline will be evaluated.

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

Primary outcomes:
measure: Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 42
timeFrame: Baseline, Day 42
Secondary outcomes:
measure: Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28
timeFrame: Baseline, Day 28
measure: Change from Baseline in K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28 and Day 42
timeFrame: Baseline, Day 28, Day 42
measure: Change from Baseline in SRS-2 (Korean Social Responsiveness Scale-2) at Day 28 and Day 42
timeFrame: Baseline, Day 28, Day 42
measure: Change from Baseline in K-PRQ-CA (Korean Parenting Relationship Questionnaire - Child & Adolescent) at Day 28 and Day 42
timeFrame: Baseline, Day 28, Day 42
measure: Change from Baseline in KIPR (Korean Inventory of Peer Relationships) at Day 28 and Day 42
timeFrame: Baseline, Day 28, Day 42
measure: Change from Baseline in EQ-5D-5L (EuroQol Five Dimension Five Level Scale) at Day 42
timeFrame: Baseline, Day 42
measure: Change from Baseline in CGI-S (Clinical Global Impression-Severity) at Day 28 and Day 42
timeFrame: Baseline, Day 28, Day 42
measure: CGI-I (Clinical Global Impression-Improvement) at Day 28 and Day 42
timeFrame: Day 28, Day 42
measure: NDTx-01 Satisfaction Questionnaire at Day 42
timeFrame: Day 42
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
affiliation: Samsung Medical Center
name: Yoo-Sook Joung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: