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NCT06311370 Clinical Trial

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

ADHD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06311370
Other study ID # 2023-0100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 9, 2023
Est. completion date February 5, 2024

Study information
Verified date March 2024
Source MaxisHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date February 5, 2024
Est. primary completion date February 5, 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 7 Years
Eligibility Inclusion Criteria: - Children in the therapeutic school, diagnosed with ADHD Exclusion Criteria: - Unable to tolerate wearing the watch

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observation
Observed by trained staff and wearing a sensor watch

Locations
Country Name City State
United States The League School Brooklyn New York

Sponsors (1)
Lead Sponsor Collaborator
MaxisHealth

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Emotion dysregulation Number of tantrums 20 hours upto 4 weeks
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