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

NCT ID: NCT06311370

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-09

Study Completion Date

2024-02-05

Brief Summary

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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

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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.

Conditions

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ADHD Autism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children age 4 to 7

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

Observation

Intervention Type OTHER

Observed by trained staff and wearing a sensor watch

Interventions

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Observation

Observed by trained staff and wearing a sensor watch

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children in the therapeutic school, diagnosed with ADHD

Exclusion Criteria

* Unable to tolerate wearing the watch
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MaxisHealth

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The League School

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2023-0100

Identifier Type: -

Identifier Source: org_study_id

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