Safety and Efficacy of NDTx-03 in Children and Adolescents With ASD or SCD

Sponsor
Neudive Inc.
Study ID
NCT07770867
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • NDTx-03 — DEVICE
    NDTx-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 — BEHAVIORAL
    TAU 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.

Study Details

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).

Key Dates

First listed
Aug 18, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NDTx-03 + TAU
    NDTx-03 plus TAU from baseline through Day 56. NDTx-03 is used five times per week for 8 weeks (40 sessions), comprising a 6-week basic application period and a 2-week advanced application period.
  • Other: TAU Alone
    TAU alone from baseline through Day 56. Optional NDTx-03 provided after the end-of-study visit under a separate post-study access process is outside the clinical trial intervention and assessment period.

Primary Outcome Measure

Change from baseline in K-VABS-II Adaptive Behavior Composite (ABC) score at Day 42 [ Time Frame: Baseline (Visit 2, Day 0) and Day 42 (Visit 4, Day 42 +/- 3 days) ]

Central Contacts

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