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Can a smartphone app teach social cues to teens with autism?

NCT ID NCT07770867

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This trial is testing whether a digital therapy app called NDTx-03, used alongside usual care, can help children and adolescents aged 10 to 18 with autism spectrum disorder or social communication disorder better recognize and respond to social situations. The app combines cognitive behavioral therapy, social information processing training, and social skills practice, adjusting difficulty to each user's abilities. Researchers will compare social adaptive behavior scores between those using the app plus usual care and those receiving usual care alone over about six weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NDTx-03, a digital medical device software that delivers cognitive behavioral therapy, social information processing training, and social skills training to improve social recognition and interaction.
What this could lead to
If effective, NDTx-03 could offer a non-drug, at-home digital therapy to help young people with autism or social communication disorder better understand and navigate social situations.
What could go wrong
This is a confirmatory trial, but success is not guaranteed. The effect may be modest, and the digital program may not work for all users or may require consistent engagement to show benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder Social Communication Disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Daegu Catholic University Medical Center

    RECRUITING

    Daegu, 42472, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, 08308, South Korea

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, 50612, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

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

    RECRUITING

    Seoul, 06591, South Korea

  • Wonkwang University Hospital

    RECRUITING

    Iksan, 54538, South Korea

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