Safety and Efficacy of NDTx-03 in Children and Adolescents With ASD or SCD

NCT07770867 | Recruiting

• 2 other identifiers: ND-06R25TA0120748700
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the safety of NDTx-03 used together with treatment as usual (TAU) and to determine whether NDTx-03 plus TAU is more effective than TAU alone in improving social situation recognition and interaction in children and adolescents with autism spectrum disorder (ASD) or social communication disorder (SCD).

Conditions

Autism Spectrum Disorder; Social Communication Disorder

Keywords

Autism Spectrum Disorder; Social Communication Disorder; ASD; SCD; Digital therapeutics; Cognitive therapeutic software; NDTx-03; Asperger; DTX; SaMD

Outcome Measures

Primary Outcomes (1)

• Change from baseline in K-VABS-II Adaptive Behavior Composite (ABC) score at Day 42

  K-VABS-II is a blinded-assessor-administered scale for individuals aged 0 to 99 years that evaluates social adaptive behavior. The ABC score is based on standardized scores for Communication, Daily Living Skills, and Socialization. The change from baseline to Day 42 will be compared between groups.

  Baseline (Visit 2, Day 0) and Day 42 (Visit 4, Day 42 +/- 3 days)

Secondary Outcomes (8)

• Change from baseline in K-VABS-II ABC score at Day 56

  Baseline (Visit 2, Day 0) and Day 56 (Visit 5, Day 56 +/- 3 days)

• Change from baseline in K-VABS-II domain scores

  Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)

• Change from baseline in K-VABS-II subscale V-scale scores

  Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)

• Change from baseline in SRS-2 total score

  Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)

• Change from baseline in SRS-2 subscale T-scores

  Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)

Other Outcomes (6)

• Change from baseline in KIPR score

  Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)

• Change from baseline in EQ-5D-5L score

  Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)

• NDTx-03 satisfaction questionnaire score

  Day 56 (Visit 5)

Study Arms (2)

NDTx-03 + TAU

EXPERIMENTAL

NDTx-03 plus TAU from baseline through Day 56. NDTx-03 is used five times per week for 8 weeks (40 sessions), comprising a 6-week basic application period and a 2-week advanced application period.

Device: NDTx-03; Behavioral: TAU

TAU Alone

OTHER

TAU alone from baseline through Day 56. Optional NDTx-03 provided after the end-of-study visit under a separate post-study access process is outside the clinical trial intervention and assessment period.

Behavioral: TAU

Interventions

NDTx-03 DEVICE

NDTx-03 is digital medical device software intended to improve social situation recognition and interaction in children and adolescents aged 10 to 18 years with ASD or SCD. It integrates cognitive behavioral therapy (CBT), the social information processing (SIP) model, and social skills training (SST) to address recognition and interpretation of social cues, goal setting, response generation and selection, and behavioral execution. The program adjusts difficulty according to the user's cognitive ability, diagnosis, and performance. In the experimental group, NDTx-03 is used on a smartphone five times per week for 8 weeks (40 sessions, a 6-week basic application period followed by a 2-week advanced application period).

NDTx-03 + TAU

TAU BEHAVIORAL

TAU consists of ASD/SCD-related treatment, rehabilitation, or education that the participant was already receiving. TAU continues during the study, but medications or treatment/rehabilitation/education programs that may significantly affect sociality should remain stable as specified in the protocol.

NDTx-03 + TAU; TAU Alone

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 aged 10 to 18 years.
• Diagnosed with Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD) by the clinical judgment of a psychiatrist according to DSM-5 diagnostic criteria, based on the Autism Diagnostic Interview-Revised (ADI-R), Korean Wechsler Intelligence Scale for Children, Fifth Edition (K-WISC-V), and clinical assessment. Previously performed ADI-R and Wechsler intelligence scale results may be used; for Wechsler intelligence scales, any test type or version may be used, including K-WISC-V, WPPSI, or WAIS.
• Full-Scale Intelligence Quotient (FSIQ) \>= 70 or General Ability Index (GAI) \>= 70 based on a Korean Wechsler intelligence scale (regardless of type or version, including K-WISC-V, WPPSI, or WAIS). Previously performed results may be used.
• Able to use NDTx-03 installed on a smartphone, either independently or with assistance from a parent/legal guardian.
• Able to comply with the recommended investigational device application schedule (5 times per week, 8 weeks, 40 sessions).
• Agree not to use any medical device other than the investigational device during the clinical trial.
• Agree that there will be no changes during the study in the regimen of medications that may significantly affect sociality. Medications being taken at screening may be continued, but total daily dose, active ingredient, and other regimen details must remain unchanged until the end-of-study visit.
• Agree not to participate in additional Applied Behavior Analysis (ABA) treatment/rehabilitation/education or sociality-related treatment/rehabilitation/education programs during the study. Programs being received at screening may be continued, but frequency and treatment method must remain unchanged until the end-of-study visit.
• The participant and parent (or legal guardian) voluntarily decide to participate and provide written informed consent/assent using the participant information sheet and informed consent form.
• Willing to comply with the clinical trial protocol.

You may not qualify if:

• Clinically significant behavioral problems, emotional regulation problems, psychotic symptoms, or risk of self-harm or harm to others at a level that may affect the treatment process.
• Severe acute or chronic medical or psychiatric disease.
• Serious trauma or surgery within 4 weeks before the screening date.
• Other severe neurological disease or disability, such as brain lesion disorder or mental disorder/disability.
• Currently participating in another clinical trial or participated in another clinical trial within 30 days before the screening date.
• Less than 24 months have elapsed since the end date of application of the investigational medical device NDTx-01 (or Buddy In) as of the screening date.
• Participation in a clinical trial of, or prior experience using, a digital therapeutic device or software-based intervention program that may affect efficacy assessments of this study, including cognitive function, attention, executive function, language, social development, social skills, behavior, or emotional regulation, within 12 months before the baseline visit.
• Within 8 weeks before baseline, a change in the dosage or regimen of medications that may significantly affect sociality, or a change in participation in treatment/rehabilitation/education programs that may significantly affect sociality.
• Any other case in which the investigator determines that participation is inappropriate for ethical reasons or because it may affect clinical trial results.

Sponsors & Collaborators

• Neudive Inc.: lead

Study Sites (7)

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

RECRUITING

Wonkwang University Hospital

Iksan, 54538, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

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

Seoul, 06591, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Social Communication Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

• Yoo Sook Joung, MD., PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SungJa Cho

CONTACT

+82-2-6959-9933; sungja_cho@neudive.com

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: August 13, 2026
• First Posted: August 18, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

KR (7)