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

NCT06446193 | Completed

• 3 other identifiers: ND-02RS-2023-00265178B0081112000610
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 5

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).

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 42

  The K-VABS-II is a tool used to assess adaptive behavior and functioning in individuals from birth to 99 years old. It evaluates personal and social skills necessary for everyday living. The scores (standard scores) range from 55 to 145, with higher scores indicating better outcomes.

  Baseline, Day 42

Secondary Outcomes (9)

• Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28

  Baseline, Day 28

• Change from Baseline in K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28 and Day 42

  Baseline, Day 28, Day 42

• Change from Baseline in SRS-2 (Korean Social Responsiveness Scale-2) at Day 28 and Day 42

  Baseline, Day 28, Day 42

• Change from Baseline in K-PRQ-CA (Korean Parenting Relationship Questionnaire - Child & Adolescent) at Day 28 and Day 42

  Baseline, Day 28, Day 42

• Change from Baseline in KIPR (Korean Inventory of Peer Relationships) at Day 28 and Day 42

  Baseline, Day 28, Day 42

Study Arms (2)

The experimental group

EXPERIMENTAL

NDTx-01 + TAU (Treatment-As-Usual)

Device: NDTx-01; Behavioral: TAU

The control group

OTHER

TAU (Treatment-As-Usual)

Behavioral: TAU

Interventions

NDTx-01 DEVICE

NDTx-01 intervention: Run 'NDTx-01' application on a smartphone 5 times a week, for 6 weeks, 30 sessions in total.

The experimental group

TAU BEHAVIORAL

TAU: Autism Spectrum Disorders(ASD) or Social Communication Disorders(SCD)-related treatment/rehabilitation/education

The control group; The experimental group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neudive Inc.: lead

Study Sites (5)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Social Communication Disorder; Communication; Social Skills; Social Adjustment; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Behavior; Social Behavior

Study Officials

• Yoo-Sook Joung, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: August 14, 2024
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)