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Autism Spectrum DisorderNCT07770867

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

A study testing NDTx-03 and TAU in people with Autism Spectrum Disorder and Social Communication Disorder, run by Neudive Inc. at 7 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 10 to 18 years
What is being tested?
NDTx-03 and TAU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
7 sitesSouth Korea
Study dates
15 Sep 2026to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

SungJa Cho contact

+82-2-6959-9933

sungja_cho@neudive.com

7 sites in 1 country

South Korea7 sites, 7 recruiting

  • Daegu Catholic University Medical Center

    Daegu, 42472

    Tae Young Choi, +82-53-650-4184, tyoungchoi@cu.ac.kr

    Recruiting

  • Wonkwang University Hospital

    Iksan, 54538

    Chan Mo Yang, +82-63-859-1115, ikarosforeve@naver.com

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Hyo Won Kim, +82-2-3010-3414, shingubi@amc.seoul.kr

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Yoo Sook Joung

    Recruiting

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

    Seoul, 06591

    JaeHyun Yoo, +82-2-2258-1511, jay.yoo84@gmail.com

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Moon Soo Lee, +82-2-2626-1114, npboard@korea.ac.kr

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

    Ji Hoon Kim, +82-55-360-2123, pnuhcap@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: 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).

Read the 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.

Being tested
NDTx-03, TAU
Keywords
Autism Spectrum Disorder, Social Communication Disorder, ASD, SCD, Digital therapeutics, Cognitive therapeutic software, NDTx-03, Asperger, DTX, SaMD
Medical subject headings
Autism Spectrum Disorder, Social Communication Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NDTx-03Device

    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).

  • TAUBehavioural

    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.

Study groups in NCT07770867
Study groupRoleWhat they receive
NDTx-03 + TAUExperimentalNDTx-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.
Receives: Device: NDTx-03; Behavioral: TAU
TAU AloneOtherTAU 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.
Receives: Behavioral: TAU

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)

  1. 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. The Korean Vineland Adaptive Behavior Scales-II (K-VABS-II) Adaptive Behavior Composite (ABC) score ranges from 20 to 160, with higher scores indicating better adaptive functioning.

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

  2. Change from baseline in K-VABS-II domain scores

    K-VABS-II domain scores include Communication, Daily Living Skills, and Socialization. The Korean Vineland Adaptive Behavior Scales-II (K-VABS-II) domain scores range from 20 to 160 with higher scores indicating better adaptive functioning.

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

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

    K-VABS-II subscale V-scale scores include Receptive, Expressive, Written, Personal, Domestic, Community, Interpersonal Relationships, Play and Leisure, Coping Skills, Internalizing, and Externalizing. The V-scale scores range from 1 to 24. Higher scores indicate better adaptive functioning for Receptive, Expressive, Written, Personal, Domestic, Community, Interpersonal Relationships, Play and Leisure, and Coping Skills, whereas higher Internalizing and Externalizing scores indicate greater maladaptive behavior.

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

  4. Change from baseline in SRS-2 total score

    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. The total score ranges from 0 to 195 with higher scores indicating greater severity of social impairment.

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

  5. Change from baseline in SRS-2 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. Subscale T-scores include Social Awareness, Social Cognition, Social Communication, Social Motivation, Restricted Interests and Repetitive Behavior (RRB), and Social Communication and Interaction (SCI). The subscale T-scores are estimated to range from 34 to 128 with higher scores indicating greater severity of social impairment.

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

  6. 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. The K-PRQ-CA subscale T-scores are estimated to range from 20 to 80 (T-score means 50, standard deviation 10). Higher scores indicate better parent-child relationships functioning for Attachment, Communication, Discipline, Involvement, Parenting Confidence, and Satisfaction with School, whereas higher Relational Frustration scores indicate greater relational frustration.

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

  7. 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.

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

  8. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start15 Sep 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07770867
Sponsor's protocol ID
ND-06
Other IDs
R25TA0120748700
Status last verified
Sep 2026
First submitted
13 Aug 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing NDTx-03 and TAU in people with Autism Spectrum Disorder and Social Communication Disorder, run by Neudive Inc. at 7 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SungJa Cho (+82-2-6959-9933, sungja_cho@neudive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in K-VABS-II Adaptive Behavior Composite (ABC) score at Day 42 (time frame: Baseline (Visit 2, Day 0) and Day 42 (Visit 4, Day 42 +/- 3 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07770867.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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