Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RS-2023-00265178 | Other Grant/Funding Number | Ministry of Health and Welfare, Republic of Korea | |
| B0081112000610 | Other Grant/Funding Number | Daegu-Gyueongbuk Medical Innovation Foundation (KMEDI hub) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The experimental group | Experimental | NDTx-01 + TAU (Treatment-As-Usual) |
|
| The control group | Other | TAU (Treatment-As-Usual) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NDTx-01 | Device | NDTx-01 intervention: Run 'NDTx-01' application on a smartphone 5 times a week, for 6 weeks, 30 sessions in total. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yoo-Sook Joung, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | 50612 | South Korea | ||
| Daegu Catholic University Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D000067404 | Social Communication Disorder |
| D003142 | Communication |
| D066107 | Social Skills |
| D012917 | Social Adjustment |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D003147 | Communication Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TAU | Behavioral | TAU: Autism Spectrum Disorders(ASD) or Social Communication Disorders(SCD)-related treatment/rehabilitation/education |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 42 |
| Daegu |
| 42472 |
| South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | 06591 | South Korea |
| D001519 | Behavior |
| D012919 | Social Behavior |