NCT06311370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

February 20, 2024

Last Update Submit

March 7, 2024

Conditions

ADHDAutism

Outcome Measures

Primary Outcomes (1)

  • Emotion dysregulation

    Number of tantrums

    20 hours upto 4 weeks

Study Arms (1)

Children age 4 to 7

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

Other: Observation

Interventions

ObservationOTHER

Observed by trained staff and wearing a sensor watch

Children age 4 to 7

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with ADHD attending the therapeutic school.

You may qualify if:

  • Children in the therapeutic school, diagnosed with ADHD

You may not qualify if:

  • Unable to tolerate wearing the watch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The League School

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAutistic Disorder

Interventions

Observation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersAutism Spectrum DisorderChild Development Disorders, Pervasive

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2024

First Posted

March 15, 2024

Study Start

August 9, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)