A Study of Internet Delivered Parent Child Interaction Therapy

NCT ID: NCT05725525

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2023-12-01

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.

Conditions

Disruptive Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Wearable Device Intervention

An open label, non randomized trial that requires all participants to wear a Garmin watch throughout the course of the trial (\~12 weeks).

Group Type: OTHER

Remote PCIT augmented with wearable devices

Intervention Type: BEHAVIORAL

Participants will be enrolled in remote PCIT and be asked to wear a Garmin watch throughout the course of the study in order to measure biometric fluctuations

Interventions

Remote PCIT augmented with wearable devices

Participants will be enrolled in remote PCIT and be asked to wear a Garmin watch throughout the course of the study in order to measure biometric fluctuations

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• 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

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Magdalena Romanowicz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magdalena Romanowicz, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

22-009425

Identifier Type: -

Identifier Source: org_study_id