Autism Spectrum DisorderNCT06446193
To Evaluate the Efficacy and Safety of 'NDTx-01' in Patients With ASD or SCD
A study testing NDTx-01 and TAU in people with Autism Spectrum Disorder and Social Communication Disorder, run by Neudive Inc. at 5 sites in South Korea.
Trial summary
The purpose of this study is to demonstrate the superiority of the treatment of cognitive therapy software 'NDTx-01' compared to TAU (Treatment-As-Usual). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Social Communication Disorder
- What is being tested?
- NDTx-01 and TAU
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 14 Aug 2024to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 between the ages of 10 and 18
- Diagnosed with autism spectrum disorder (ASD) or social communication disorder (SCD) based on the clinical judgment of a psychiatrist according to DSM-5 diagnostic criteria
- Participants who are able to install 'NDTx-01' on an Android smartphone and use it alone or with the help of their guardian
- Participants who are able to comply with the recommended application time for the investigational medical device (6 weeks, 30 times, 5 times a week)
- Participants who have agreed not to use any other medical devices besides the investigational medical device during the clinical trial
- Participants who agree that there should be no change in the use of drugs which can significantly affect one's sociality during the clinical trial (If there is a drug being taken during screening, it can be taken continuously, but the total daily dose, ingredients, etc., should remain unchanged until the end of the study visit.)
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- Participants who agree not to participate in other Applied Behavior Analysis (ABA) treatment/rehabilitation/education, social treatment/rehabilitation/education program (If there is treatment/rehabilitation/education being received during screening, it can be received continuously, but the number of applications and treatment methods should remain unchanged until the end of the study visit.)
- Participants who and whose parents (legal guardians) have volunteered to participate in this clinical trial and have given written consent to the subject description and consent form
- Participants willing to comply with the clinical trial procedures
Who cannot join
- A risk of clinically significant behavioral problems, emotion regulation problems, psychotic symptoms, self-harm, or other harm at a level that affects the treatment process
- Severe acute/chronic medical or mental illness
- Serious trauma or surgery performed within 4 weeks before the screening date
- Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.)
- Participants who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening date
- Participants with a previous history of using NDTx-01, the investigational device
- Participants who have a change in the usage or dosage of drugs which can significantly affect one's sociality, or a change in participation in treatment/rehabilitation/education programs that can significantly affect one's sociality within 8 weeks before the baseline date of the clinical trial
- In other cases where the investigator determines that participation in the clinical trial is inappropriate due to ethical reasons or the possibility of influencing the results of the clinical trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Daegu Catholic University Medical Center
Daegu, 42472
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: A Multi-center, Randomized, Assessor-blind, Superiority, Confirmatory Clinical Trial to Assess Safety and Efficacy of Cognitive Therapy Software 'NDTx-01' for Improving Social Awareness and Interaction in Children and Adolescents With Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD)
The purpose of this study is to demonstrate the superiority of the treatment of cognitive therapy software 'NDTx-01' compared to TAU (Treatment-As-Usual).
Read the detailed description
This confirmatory clinical trial aims to demonstrate the superiority of 'NDTx-01' by comparing and evaluating the efficacy and safety of the experimental group applying 'NDTx-01' with TAU (Treatment-As-Usual) and the control group applying TAU only.
The study participants will be randomized in a 1:1 as experimental group and control group. The experimental group applies 'NDTx-01' 30 times for 6 weeks (5 times a week) with TAU and the control group gets TAU only. For the primary purpose, the change in the adaptive behavior combination (ABC) score of the Korean version of the Vineland Adaptive Behavior Scale-II (K-VABS-II) at 42 days compared to the baseline will be evaluated.
- Being tested
- NDTx-01, TAU
- Keywords
- autism spectrum disorder, social communication disorder, digital therapeutics, adolescents, social communication, social skills, social adaptation, autistic, cognitive behavior therapy, social stories, peer relationship, intervention
- Medical subject headings
- Autism Spectrum Disorder, Social Communication Disorder, Communication, Social Skills, Social Adjustment, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDTx-01Device
NDTx-01 intervention: Run 'NDTx-01' application on a smartphone 5 times a week, for 6 weeks, 30 sessions in total.
TAUBehavioural
TAU: Autism Spectrum Disorders(ASD) or Social Communication Disorders(SCD)-related treatment/rehabilitation/education
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | NDTx-01 + TAU (Treatment-As-Usual) Receives: Device: NDTx-01; Behavioral: TAU |
| The control group | Other | TAU (Treatment-As-Usual) Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 42
The K-VABS-II is a tool used to assess adaptive behavior and functioning in individuals from birth to 99 years old. It evaluates personal and social skills necessary for everyday living. The scores (standard scores) range from 55 to 145, with higher scores indicating better outcomes.
Measured: Baseline, Day 42
Secondary outcomes (9)
Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28
The K-VABS-II is a tool used to assess adaptive behavior and functioning in individuals from birth to 99 years old. It evaluates personal and social skills necessary for everyday living. The scores (standard scores) range from 55 to 145, with higher scores indicating better outcomes.
Measured: Baseline, Day 28
Change from Baseline in K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28 and Day 42
The K-VABS-II is a tool used to assess adaptive behavior and functioning in individuals from birth to 99 years old. It evaluates personal and social skills necessary for everyday living. The scores (standard scores) range from 55 to 145, with higher scores indicating better outcomes.
Measured: Baseline, Day 28, Day 42
Change from Baseline in SRS-2 (Korean Social Responsiveness Scale-2) at Day 28 and Day 42
The SRS-2 consists of a series of questions answered by parents or caregivers who observe the individual's behavior. It is a tool used to assess social skills, social cognition, and behaviors associated with autism spectrum disorders (ASD) in children and adolescents. It's designed to help clinicians, educators, and researchers identify and understand social impairments commonly seen in individuals with ASD or other developmental disorders. The T scores range from 34 to 128, with higher scores indicating worse outcomes.
Measured: Baseline, Day 28, Day 42
Change from Baseline in K-PRQ-CA (Korean Parenting Relationship Questionnaire - Child & Adolescent) at Day 28 and Day 42
The K-PRQ-CA is a tool designed to assess the quality of the relationship between parents and their children or adolescents. It's used to evaluate various aspects of the parent-child relationship, including communication, support, discipline, and overall satisfaction. The T scores of K-PRQ-CA are estimated to be 20 to 80 (T score mean 50, standard deviation 10), with higher scores indicating better outcomes.
Measured: Baseline, Day 28, Day 42
Change from Baseline in KIPR (Korean Inventory of Peer Relationships) at Day 28 and Day 42
The KIPR is a tool used to assess peer relationships among Korean children and adolescents. It's designed to measure various aspects of peer interactions, including social skills, peer acceptance, peer rejection, and the quality of friendships. The T scores of KIPR are estimated to be 20 to 80 (T score mean 50, standard deviation 10), with higher scores indicating worse outcomes.
Measured: Baseline, Day 28, Day 42
Change from Baseline in EQ-5D-5L (EuroQol Five Dimension Five Level Scale) at Day 42
The EQ-5D-5L is a standardized measure of health-related quality of life developed by the EuroQol Group. It's used to assess a person's health status and well-being across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The "5L" in EQ-5D-5L stands for "five levels," indicating that each dimension has five response levels ranging from no problems to extreme problems. The score for each dimension is from 1 to 5, with higher scores indicating worse outcomes. And the score ranging from 0 to 100 means that the higher the score, the better the outcome.
Measured: Baseline, Day 42
Change from Baseline in CGI-S (Clinical Global Impression-Severity) at Day 28 and Day 42
The CGI-S is a widely used clinician-rated scale designed to assess the overall severity of a patient's condition in clinical trials. Clinicians typically rate the CGI-S on a seven-point scale, where each point represents a different level of severity. The score ranges from 1 to 7, with higher scores indicating worse outcomes.
Measured: Baseline, Day 28, Day 42
CGI-I (Clinical Global Impression-Improvement) at Day 28 and Day 42
The CGI-I is a clinician-rated scale used to assess changes in a patient's overall clinical condition or improvement over time, particularly in clinical trials. Clinicians typically rate the CGI-I on a seven-point scale, where each point represents a different level of improvement compared to baseline. The score ranges from 1 to 7, with higher scores indicating worse outcomes.
Measured: Day 28, Day 42
NDTx-01 Satisfaction Questionnaire at Day 42
The 'NDTx-01 Satisfaction Questionnaire' includes 4 questions related to satisfaction with the experience of using the investigational device. The score for each question is from 0 to 10, with higher scores indicating better outcomes.
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start14 Aug 2024
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neudive Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoo-Sook Joung, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446193
- Sponsor's protocol ID
- ND-02
- Other IDs
- RS-2023-00265178, B0081112000610
- Status last verified
- Feb 2025
- First submitted
- 31 May 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Assessor-blind, Superiority, Confirmatory Clinical Trial to Assess Safety and Efficacy of Cognitive Therapy Software 'NDTx-01' for Improving Social Awareness and Interaction in Children and Adolescents With Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD)
- ClinicalTrials.gov ID
- NCT06446193
- Acronym / sponsor ID
- ND-02
- Keywords
- autism spectrum disorder, social communication disorder, digital therapeutics, adolescents, social communication, social skills, social adaptation, autistic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Neudive Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the superiority of the treatment of cognitive therapy software 'NDTx-01' compared to TAU (Treatment-As-Usual).
Detailed description
This confirmatory clinical trial aims to demonstrate the superiority of 'NDTx-01' by comparing and evaluating the efficacy and safety of the experimental group applying 'NDTx-01' with TAU (Treatment-As-Usual) and the control group applying TAU only.
The study participants will be randomized in a 1:1 as experimental group and control group. The experimental group applies 'NDTx-01' 30 times for 6 weeks (5 times a week) with TAU and the control group gets TAU only. For the primary purpose, the change in the adaptive behavior combination (ABC) score of the Korean version of the Vineland Adaptive Behavior Scale-II (K-VABS-II) at 42 days compared to the baseline will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Device: NDTx-01, Behavioral: TAUNDTx-01 + TAU (Treatment-As-Usual) |
| The control group | Other | Behavioral: TAUTAU (Treatment-As-Usual) |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Children and adolescents between the ages of 10 and 18
- Diagnosed with autism spectrum disorder (ASD) or social communication disorder (SCD) based on the clinical judgment of a psychiatrist according to DSM-5 diagnostic criteria
- Participants who are able to install 'NDTx-01' on an Android smartphone and use it alone or with the help of their guardian
- Participants who are able to comply with the recommended application time for the investigational medical device (6 weeks, 30 times, 5 times a week)
- Participants who have agreed not to use any other medical devices besides the investigational medical device during the clinical trial
Key exclusion criteria (8 listed)
- A risk of clinically significant behavioral problems, emotion regulation problems, psychotic symptoms, self-harm, or other harm at a level that affects the treatment process
- Severe acute/chronic medical or mental illness
- Serious trauma or surgery performed within 4 weeks before the screening date
- Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.)
- Participants who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NDTx-01NDTx-01 intervention: Run 'NDTx-01' application on a smartphone 5 times a week, for 6 weeks, 30 sessions in total. | Device | The experimental group |
| TAUTAU: Autism Spectrum Disorders(ASD) or Social Communication Disorders(SCD)-related treatment/rehabilitation/education | Behavioural | The control group, The experimental group |
Primary outcome
Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 42
Time frame: Baseline, Day 42
The K-VABS-II is a tool used to assess adaptive behavior and functioning in individuals from birth to 99 years old. It evaluates personal and social skills necessary for everyday living. The scores (standard scores) range from 55 to 145, with higher scores indicating better outcomes.
9 secondary outcomes
Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28
Time frame: Baseline, Day 28
Change from Baseline in K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28 and Day 42
Time frame: Baseline, Day 28, Day 42
Change from Baseline in SRS-2 (Korean Social Responsiveness Scale-2) at Day 28 and Day 42
Time frame: Baseline, Day 28, Day 42
Change from Baseline in K-PRQ-CA (Korean Parenting Relationship Questionnaire - Child & Adolescent) at Day 28 and Day 42
Time frame: Baseline, Day 28, Day 42
Change from Baseline in KIPR (Korean Inventory of Peer Relationships) at Day 28 and Day 42
Time frame: Baseline, Day 28, Day 42
Change from Baseline in EQ-5D-5L (EuroQol Five Dimension Five Level Scale) at Day 42
Time frame: Baseline, Day 42
Change from Baseline in CGI-S (Clinical Global Impression-Severity) at Day 28 and Day 42
Time frame: Baseline, Day 28, Day 42
CGI-I (Clinical Global Impression-Improvement) at Day 28 and Day 42
Time frame: Day 28, Day 42
NDTx-01 Satisfaction Questionnaire at Day 42
Time frame: Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoo-Sook Joung, MD, PhD principal investigator
Samsung Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NDTx-01 and TAU in people with Autism Spectrum Disorder and Social Communication Disorder, run by Neudive Inc. at 5 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 42 (time frame: Baseline, Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2025.