Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-24

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to develop an innovative wearable tracking protocol that will use Artificial Intelligence (AI) technology to monitor sleep and behavior of 3-7 year old children.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Internet Delivered Parent Child Interaction Therapy

NCT05725525

Disruptive Behavior

COMPLETED NA

Treatment of Sleep Disturbances in Young Children With Autism

NCT01322022

Autism Autism Spectrum Disorders

COMPLETED NA

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

NCT06311370

ADHD Autism

COMPLETED

Mobile Health Sleep and Growth Study 2

NCT03426644

Childhood Sleep Promotion

COMPLETED NA

Task-Based Grounding Program

NCT04648553

Aggressive Defiant Disorder, Oppositional Attention Deficit Hyperactivity Disorder

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disruptive Behavior Attention-deficit Hyperactivity Oppositional Defiant Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AI Parent Child Interaction Therapy

Subjects enrolled in Parent Child Interaction Therapy (PCIT) will wear a Garmin smartwatch that will provided targeted messages during tantrums picked up by the Garmin devices that will instruct them on how to deescalate their child.

Group Type EXPERIMENTAL

Garmin

Intervention Type DEVICE

A smartwatch device that measures subjects level of activity, heartrate, respirations and quality of your sleep at night. Artificial intelligence will be applied to analyze all the data over the course of 12 weeks to monitor and attempt to predict the onset of tantrums or disruptive behavior. Subjects are required to wear the watch at least 70% of the day and night each day for 70% of days during 12 weeks of treatment.

Sham Biometric - Parent Child Interaction Therapy

Subjects enrolled in Parent Child Interaction Therapy will wear Garmin smartwatch and will receive only random messages throughout the day with various relaxation strategies such as reminders to practice deep breathing with their child.

Group Type SHAM_COMPARATOR

Garmin

Intervention Type DEVICE

A smartwatch device that measures subjects level of activity, heartrate, respirations and quality of your sleep at night. Artificial intelligence will be applied to analyze all the data over the course of 12 weeks to monitor and attempt to predict the onset of tantrums or disruptive behavior. Subjects are required to wear the watch at least 70% of the day and night each day for 70% of days during 12 weeks of treatment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Garmin

A smartwatch device that measures subjects level of activity, heartrate, respirations and quality of your sleep at night. Artificial intelligence will be applied to analyze all the data over the course of 12 weeks to monitor and attempt to predict the onset of tantrums or disruptive behavior. Subjects are required to wear the watch at least 70% of the day and night each day for 70% of days during 12 weeks of treatment.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ages 3-7.
* Outpatients or Inpatients.
* Any gender, race or ethnicity.
* Able to provide developmentally appropriate informed assent, and legal guardians able to provide informed consent .
* EBP Severity rated above the clinically significant range (≥120; T-score ≥ 60) (Eyberg Child Behavior Inventory- ECBI; Eyberg \& Pincus, 1999).
* Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.
* Families approached for participation will be asked to commit to complete the treatment.
* At least one primary caregiver and the identified child will have to be able to speak and understand English.

* Agree to wear Garmin watch.
* Ages 18-99.
* Any gender, race, ethnicity.
* Able to provide informed consent.

Exclusion Criteria

* Formal diagnosis of Severe Intellectual disability, Autistic Spectrum Disorder Level 3, or a psychotic disorder for the child.
* Parents not consenting to the study.
* Parents or child is not able to adhere to the study protocol.
* A Child who is reasonable expected to be unable to tolerate wearing the Garmin device for at least 70% of the time during the day and night 70% of the days during the treatment (12 weeks). This is based on the principal investigator's discretion.
* Unable to speak and understand English.
* Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
* Children in foster care.

* Unable to speak and understand English.
* Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.

Minimum Eligible Age

3 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes