Clinical trial NCT05725525: A Study of Internet Delivered Parent Child Interaction Therapy
Official title: Feasibility of Internet Delivered Parent Child Interaction Therapy (AI I-PCIT) Real-Time Monitoring of Sleep and Behavior of Children 3-7 Years-Old Receiving Remote PCIT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disruptive Behavior
Keywords: Garmin Watch
Artificial Intelligence
PCIT
Telehealth
Technology
Decentralized Trial
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 5
Sex: ALL
Minimum age (years): 3
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn more about how feasible remote parent child interaction therapy (PCIT) is for children with disruptive behaviors and how to augment treatment with wearable devices.

Detailed description: Children with disruptive behaviors aged 3-7 will wear a Garmin watch throughout the course of the study (approximately 12 weeks). Artificial Intelligence (AI) will be applied to analyze the vitals provided by the watch to monitor for disruptive behavior. Parent and child will be enrolled in remote PCIT sessions throughout the course of the trial. This study will not require any in person visits, all materials will be mailed to the patients home or sent electronically. The study will analyze how the use of a wearable device throughout PCIT will help increase the benefit to both parent and child as measured by biometrics via Garmin and by questionnaires preformed throughout the trial.

Eligibility criteria: Inclusion Criteria - Children (Aged 3-7):

* Outpatients.
* 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;
* Must have the ability, technology, and internet access for remote therapy/research visits.

Inclusion Criteria - Adults (Any age):

* Agree to wear Garmin watch.
* Able to provide informed consent.
* Able to speak and understand English.
* Has the ability, technology, and internet access for remote therapy/research visits.

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.
* Does not have the ability, technology, and/or internet access for remote therapy/research visits.
* Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.

Exclusion Criteria - Adults:

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

Primary outcomes:
measure: How wearing a Garmin watch will help the remote PCIT clinical outcomes
timeFrame: Through study completion, approximately 2 years
measure: Number of participants able to wear the Garmin watch throughout remote PCIT
timeFrame: Through study completion, approximately 2 years
measure: Evaluating parental acceptance of remote PCIT augmented with a Garmin device
timeFrame: Through study completion, approximately 2 years
Secondary outcomes:
measure: Evaluating clinical improvement from remote PCIT in regards to sleep
timeFrame: Through study completion, approximately 2 years
measure: Evaluating clinical improvement from remote PCIT in regards to parental reports of behavior accuracy of indirect behavioral measures from wearable devices to parental ratings
timeFrame: Through study completion, approximately 2 years
measure: Evaluating measured sleep data throughout remote PCIT
timeFrame: Through study completion, approximately 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Magdalena Romanowicz, MD
role: PRINCIPAL_INVESTIGATOR
References: