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

NCT05077722 | Completed

• 1 other identifier: 21-007403
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Disruptive Behavior; Attention-deficit Hyperactivity; Oppositional Defiant Disorder

Keywords

Emotional Behavioral Dyscontrol

Outcome Measures

Primary Outcomes (1)

• Frequency of Garmin use

  Number of days participants wear the Garmin smartwatch

  12 weeks

Secondary Outcomes (2)

• Eyberg Child Behavior Inventory

  12 weeks

• Pediatric Sleep Questionnaire

  12 weeks

Study Arms (2)

AI Parent Child Interaction Therapy

EXPERIMENTAL

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

Sham Biometric - Parent Child Interaction Therapy

SHAM COMPARATOR

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

Interventions

Garmin 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.

AI Parent Child Interaction Therapy; Sham Biometric - Parent Child Interaction Therapy

Eligibility Criteria

• Age: 3 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• Agree to wear Garmin watch.
• Ages 18-99.
• Any gender, race, ethnicity.
• Able to provide informed consent.
• Unable to speak and understand English.
• Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Romanowicz M, Saliba MT, Wilton AR, Garzon Hincapie JF, Croarkin KS, Saliba CT, LeMahieu A, Drapeau N, Schlichting B, Skime M, Bobo WV, Vande Voort JL, Shekunov J, Croarkin PE, Athreya AP. Feasibility of Digital Augmentation of Parent-Child Interaction Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548869. doi: 10.1001/jamanetworkopen.2025.48869.

  PMID: 41396603 DERIVED

• Saliba M, Drapeau N, Skime M, Hu X, Accardi CJ, Athreya AP, Kolacz J, Shekunov J, Jones DP, Croarkin PE, Romanowicz M. PISTACHIo (PreemptIon of diSrupTive behAvior in CHIldren): real-time monitoring of sleep and behavior of children 3-7 years old receiving parent-child interaction therapy augment with artificial intelligence - the study protocol, pilot study. Pilot Feasibility Stud. 2023 Feb 9;9(1):23. doi: 10.1186/s40814-023-01254-w.

  PMID: 36759915 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Problem Behavior; Oppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Paul Croarkin, DO, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: March 24, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

US (1)