A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorNeudive Inc.
About this trial
The purpose of this study is to explore the preliminary safety and effectiveness of the digital therapeutic device 'NDTx-02' in supporting improvements of executive function in children and adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD).
Eligibility criteria
Qualifiers
Children and adolescents aged 5 to 12 years at the time of screening
Diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)* by a psychiatrist according to DSM-5 diagnostic criteria
Full-Scale Intelligence Quotient (FSIQ) of 65 or higher
Able to use the 'NDTx-02' installed on a tablet, alone or with the assistance of a guardian
Disqualifiers
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.)
Trial design
Treatments tested in this trial
- NDTx-02 + TAU
- TAU
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov