Safety and Efficacy of NDTx-03 in Children and Adolescents With ASD or SCD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorNeudive Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
NDTx-03
DeviceNDTx-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).
TAU
BehavioralTAU 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.
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: NDTx-03 + TAUExperimental treatment 2 interventions
Group B: TAU AloneOther 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline (Visit 2, Day 0) and Day 42 (Visit 4, Day 42 +/- 3 days)Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)Other outcomes
1
Change from baseline in KIPR score
The Korean Inventory of Peer Relationships (KIPR) is a self-report assessment for children and adolescents that evaluates peer relationships and consists of 64 items. The KIPR subscale and Total T-scores are estimated to range from 20 to 80, with higher scores indicating greater difficulties in peer relationships.
Time frame
Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)2
Change from baseline in EQ-5D-5L score
The Korean version of the EuroQol Five Dimension Five Level Scale (EQ-5D-5L) is a standardized instrument for describing and valuing health-related quality of life. It consists of five items rated on a 1- to 5-point scale.
Time frame
Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)3
NDTx-03 satisfaction questionnaire score
The NDTx-03 satisfaction questionnaire assesses the participant's experience with NDTx-03. It consists of four items rated on a 0- to 10-point scale.
Time frame
Day 56 (Visit 5)4
Change from baseline in adolescent smartphone addiction self-diagnosis score
The Adolescent Smartphone Addiction Self-Diagnosis Scale is a self-report tool developed based on internet addiction and mobile phone addiction scales. It consists of 15 items rated on a 4-point scale. The total score ranges from 15 to 60 with higher scores indicating a greater risk of smartphone addiction.
Time frame
Baseline (Visit 2, Day 0) and Day 56 (Visit 5, Day 56 +/- 3 days)Sponsors and contacts
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Source ClinicalTrials.gov