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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05077722

Collaborator

(none)

100

Enrollment

Location

Arms

12.2

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Disruptive Behavior Attention-deficit Hyperactivity Oppositional Defiant Disorder	Device: Garmin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

PISTACHIO (Preemption Of Disruptive Behavior In Children) Real-Time Monitoring Of Sleep And Behavior Of Children 3-7-Year-Old Receiving Parent Child Interaction Therapy Augmented With Artificial Intelligence Randomized Controlled Trial

Actual Study Start Date :

Mar 22, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Mar 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Sham Comparator: 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.	Device: 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.

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Sham Comparator: 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.

Device: Garmin

Outcome Measures

Primary Outcome Measures

Frequency of Garmin use [12 weeks]
Number of days participants wear the Garmin smartwatch

Secondary Outcome Measures

Eyberg Child Behavior Inventory [12 weeks]
The Eyberg Child Behavior Inventory questionnaire is measured on two subscales for a series of phrases that describe a children's behavior. The first subscale is for indicating the frequency of the behavior using a scale of 1= never to 7 = Always; the second subscale indicates yes = 1 or no = 0 for whether the behavior is currently a problem for them. Reponses are total with a higher score indicating greater severity of child's behavior.
Pediatric Sleep Questionnaire [12 weeks]
Pediatric Sleep Questionnaire to assess child's sleep with a series of 22 questions on a yes/no problem scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria - Children:

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.

Exclusion Criteria - Children:

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.

Inclusion Criteria - Adults:

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

Exclusion Criteria - Adults:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Paul Croarkin, DO, MS, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Paul E. Croarkin, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05077722

Other Study ID Numbers:

21-007403

First Posted:

Oct 14, 2021

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Paul E. Croarkin, Principal Investigator, Mayo Clinic

Emotional Behavioral Dyscontrol

Additional relevant MeSH terms:

Problem Behavior

Attention Deficit and Disruptive Behavior Disorders

Study Results

No Results Posted as of Apr 6, 2022