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

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Brief Title

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

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

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.
    



Study Type

Interventional


Primary Outcome

Frequency of Garmin use

Secondary Outcome

 Eyberg Child Behavior Inventory

Condition

Disruptive Behavior

Intervention

Garmin

Study Arms / Comparison Groups

 AI Parent Child Interaction Therapy
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

100

Start Date

November 1, 2021

Completion Date

March 28, 2023

Primary Completion Date

December 30, 2022

Eligibility Criteria

        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.
      

Gender

All

Ages

3 Years - 99 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Paul Croarkin, DO, MS, 507-255-6782, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05077722

Organization ID

21-007403


Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic


Study Sponsor

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


Verification Date

October 2021