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

A Multicenter, Prospective, Randomized, Evaluator-Blinded, Superiority, Confirmatory Trial to Evaluate Safety and Efficacy of NDTx-03 for Improving Social Situation Recognition and Interaction in Children and Adolescents With ASD or SCD

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder; Social Communication Disorder
• Intervention / Treatment: Device: NDTx-03; Behavioral: TAU

Detailed Description

This is a multicenter, prospective, randomized, evaluator-blinded, superiority, confirmatory clinical trial of NDTx-03 in children and adolescents with ASD or SCD.

Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to the experimental group or the control group. All participants will maintain their existing ASD/SCD-related treatment, rehabilitation, or education program as Treatment-As-Usual (TAU) during the study.

Experimental group: Participants will receive NDTx-03 in addition to TAU from baseline. NDTx-03 will be used five times per week for 8 weeks (40 sessions), consisting of a 6-week basic application period followed by a 2-week advanced application period.

Control group: Participants will receive TAU alone for 8 weeks. After the Day 56 end-of-study visit, participants who wish to receive NDTx-03 may receive it under a separate post-study access consent process. This optional post-study use is not part of the randomized clinical trial intervention or efficacy-assessment period.

Study assessments include screening, baseline (Day 0), a telephone visit at Day 21, an in-person assessment at Day 42, and the end-of-study visit at Day 56. The primary efficacy endpoint is the between-group difference in change from baseline to Day 42 in the K-VABS-II Adaptive Behavior Composite score. Secondary efficacy assessments include K-VABS-II, SRS-2, K-PRQ-CA, CGI-S, and CGI-I. Other pre-specified assessments include KIPR, EQ-5D-5L, NDTx-03 satisfaction, adolescent smartphone addiction self-diagnosis, and TAU-related expenditures. Adverse events are recorded after written informed consent. Participants with adverse events are followed for up to 30 days after the last NDTx-03 application or until resolution, as applicable.

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SungJa Cho; Phone Number: +82-2-6959-9933; Email: sungja_cho@neudive.com

Study Locations

• South Korea
  • Daegu, South Korea, 42472
    • Daegu Catholic University Medical Center
  • Iksan, South Korea, 54538
    • Wonkwang University Hospital
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Yangsan, South Korea, 50612
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children and adolescents aged 10 to 18 years.
2. 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.
3. 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.
4. Able to use NDTx-03 installed on a smartphone, either independently or with assistance from a parent/legal guardian.
5. Able to comply with the recommended investigational device application schedule (5 times per week, 8 weeks, 40 sessions).
6. Agree not to use any medical device other than the investigational device during the clinical trial.
7. 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.
8. 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.
9. 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.
10. Willing to comply with the clinical trial protocol.

Exclusion Criteria:

1. 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.
2. Severe acute or chronic medical or psychiatric disease.
3. Serious trauma or surgery within 4 weeks before the screening date.
4. Other severe neurological disease or disability, such as brain lesion disorder or mental disorder/disability.
5. Currently participating in another clinical trial or participated in another clinical trial within 30 days before the screening date.
6. 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.
7. 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.
8. 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.
9. Any other case in which the investigator determines that participation is inappropriate for ethical reasons or because it may affect clinical trial results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NDTx-03 + TAU; 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; 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).; Behavioral: TAU; 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.
Other: TAU Alone; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in K-VABS-II ABC score at Day 56	The change from baseline to Day 56 in the K-VABS-II ABC score will be evaluated as a secondary efficacy endpoint.	Baseline (Visit 2, Day 0) and Day 56 (Visit 5, Day 56 +/- 3 days)
Change from baseline in K-VABS-II domain scores and subscale V-scale scores	K-VABS-II domain scores include Communication, Daily Living Skills, and Socialization. Subscale V-scale scores include Receptive, Expressive, Written, Personal, Domestic, Community, Interpersonal Relationships, Play and Leisure, Coping Skills, Internalizing, and Externalizing.	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 and subscale T-scores	The Korean Social Responsiveness Scale-2 (SRS-2) is a parent-rated 65-item scale used to identify the presence and severity of social impairment in autism and distinguish it from impairment related to other disorders. Total score and subscale T-scores will be evaluated.	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-PRQ-CA score	The Korean Parenting Relationship Questionnaire - Child & Adolescent (K-PRQ-CA) is a parent/caregiver-rated scale for children and adolescents from elementary school through high school. It measures the parent or primary caregiver perspective on the parent-child relationship and consists of 71 items.	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 CGI-S score	The Clinical Global Impression-Severity (CGI-S) is a clinician-rated 1-item scale scored from 1 to 7. It evaluates the current severity of symptoms compared with previous patients diagnosed with the same condition.	Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
CGI-I score	The Clinical Global Impression-Improvement (CGI-I) is a clinician-rated 1-item scale scored from 1 to 7. It evaluates whether the participant's mental disorder has improved compared with a specified previous time point.	Day 42 (Visit 4, Day 42 +/- 3 days) and Day 56 (Visit 5, Day 56 +/- 3 days); additional exploratory assessment at Day 98 (Visit 7, Day 98 +/- 3 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in KIPR score	The Korean Inventory of Peer Relationships (KIPR) is a self-report assessment for children and adolescents that evaluates peer relationships and consists of 64 items.	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	The Korean version of the EuroQol Five Dimension Five Level Scale (EQ-5D-5L) is a standardized instrument for describing and valuing health-related quality of life. It consists of five items rated on a 1- to 5-point scale.	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	The NDTx-03 satisfaction questionnaire assesses the participant's experience with NDTx-03. It consists of four items rated on a 0- to 10-point scale.	Day 56 (Visit 5)
Change from baseline in adolescent smartphone addiction self-diagnosis score	The adolescent smartphone addiction self-diagnosis scale is a self-report tool developed based on internet addiction and mobile phone addiction scales. It consists of 15 items rated on a 4-point scale.	Baseline (Visit 2, Day 0) and Day 56 (Visit 5, Day 56 +/- 3 days)
Monthly TAU-related total expenditure and medical cost	TAU-related monthly total expenditure and monthly medical cost will be collected and summarized as basic data for economic evaluation.	Screening (Visit 1, Day -28 to Day 0)
Number and percentage of participants with treatment-emergent adverse events (TEAEs)	Adverse events occurring after investigational device application will be classified as TEAEs and analyzed for safety. AEs occurring before application of the investigational device will be recorded as pretreatment AEs but excluded from the TEAE analysis.	From investigational device application through the end of study, up to Day 56 (Visit 5, Day 56 +/- 3 days)

Collaborators and Investigators

• Sponsor: Neudive Inc.
• Investigators: Principal Investigator: Yoo Sook Joung, MD., PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 13, 2026
• First Submitted That Met QC Criteria: August 13, 2026
• First Posted (Actual): August 18, 2026

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 13, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: ASD; Autism Spectrum Disorder; SCD; Digital therapeutics; SaMD; Asperger; Social Communication Disorder; Cognitive therapeutic software; NDTx-03; DTX
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Communication Disorders; Autism Spectrum Disorder; Social Communication Disorder
• Other Study ID Numbers: ND-06; R25TA0120748700 (Other Grant/Funding Number: National Center for Mental Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No