Acceptability, Feasibility, and Development of an AI Driven, Multi-sensor, Non-invasive Digital Mental Health Platform in Children With ADHD and Emotional Symptoms

This is an observational study collecting data using a wearable to measure the biometric features in youth with Attention deficit hyperactivity disorder(ADHD) and Autism.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The League School

Brooklyn, New York, 11203, United States

About this study

Participants in therapeutic school for disruptive behavior with Attention deficit hyperactivity disorder( ADHD), Autism with age 4-7 year old. Participant will wear watch during their school days for 5 days in presence of investigator and raters taking behavioral observation. The data collected from the raters and wearable will be analyzed to correlate emotional dysregulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children in the therapeutic school, diagnosed with ADHD

Exclusion criteria

Unable to tolerate wearing the watch

Treatment and study plan

observation

Other

Observed by trained staff and wearing a sensor watch

Primary outcomes

Emotion dysregulation

Time frame: 20 hours upto 4 weeks

Number of tantrums

Sponsors and collaborators

Lead sponsor

MaxisHealth

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Mar 15, 2024
Registry last updated: Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed