Can a smartphone app teach social cues to teens with autism?
NCT ID NCT07770867
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
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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
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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10 to 18 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Daegu Catholic University Medical Center
RECRUITINGDaegu, 42472, South Korea
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Korea University Guro Hospital
RECRUITINGSeoul, 08308, South Korea
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Pusan National University Yangsan Hospital
RECRUITINGYangsan, 50612, South Korea
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITINGSeoul, 06591, South Korea
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Wonkwang University Hospital
RECRUITINGIksan, 54538, South Korea
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