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Clinical Trials/NCT06311370
NCT06311370
Completed
Not Applicable

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

MaxisHealth1 site in 1 country10 target enrollmentAugust 9, 2023
ConditionsADHDAutism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ADHD
Sponsor
MaxisHealth
Enrollment
10
Locations
1
Primary Endpoint
Emotion dysregulation
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 9, 2023
End Date
February 5, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children in the therapeutic school, diagnosed with ADHD

Exclusion Criteria

  • Unable to tolerate wearing the watch

Outcomes

Primary Outcomes

Emotion dysregulation

Time Frame: 20 hours upto 4 weeks

Number of tantrums

Study Sites (1)

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