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

Completed

• Conditions: ADHD; Autism
• Interventions: Other: Observation

• Registration Number: NCT06311370
• Lead Sponsor: MaxisHealth

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.

Study Timeline

• Study Start: 2023-08-09
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-05
• Study First Submitted: 2024-02-20
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Children in the therapeutic school, diagnosed with ADHD

Exclusion Criteria

• Unable to tolerate wearing the watch

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children age 4 to 7	Observation	Children age 4-7 in therapeutic school, diagnosed with ADHD, Autism monitored with raters and the sensor watch.

Primary Outcome Measures

Name	Time	Method
Emotion dysregulation	20 hours upto 4 weeks	Number of tantrums

Trial Locations

Locations (1)

The League School; 🇺🇸 Brooklyn, New York, United States