A Study of Internet Delivered Parent Child Interaction Therapy

NCT05725525 | Completed

• 1 other identifier: 22-009425
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Disruptive Behavior

Keywords

Garmin Watch; Artificial Intelligence; PCIT; Telehealth; Technology; Decentralized Trial

Outcome Measures

Primary Outcomes (3)

• How wearing a Garmin watch will help the remote PCIT clinical outcomes

  Biometrics from the Garmin watch will be analyzed through Fitabase: step count, activity intensity, calories, heartrate, and respirations. This data will be compared throughout the study to see if factors trend down by the end of the trial. This would indicate that the child's behaviors were calmer at the end of the therapy when compared to the beginning.

  Through study completion, approximately 2 years

• Number of participants able to wear the Garmin watch throughout remote PCIT

  The study will measure how often participants are wearing the device by monitoring two platforms that are paired with the watch: Fitabase and Ilumivu. These platforms inform the study team with wear time of the watch by the participant. A measurement of at least 70% of the time will be deemed feasible/acceptable for young patient's ability to wear the watch during therapy.

  Through study completion, approximately 2 years

• Evaluating parental acceptance of remote PCIT augmented with a Garmin device

  At the end of therapy, the parent will receive an emailed survey asking about their opinions of the study technology and how it added to their child's therapy experience.

  Through study completion, approximately 2 years

Secondary Outcomes (3)

• Evaluating clinical improvement from remote PCIT in regards to sleep

  Through study completion, approximately 2 years

• Evaluating clinical improvement from remote PCIT in regards to parental reports of behavior accuracy of indirect behavioral measures from wearable devices to parental ratings

  Through study completion, approximately 2 years

• Evaluating measured sleep data throughout remote PCIT

  Through study completion, approximately 2 years

Study Arms (1)

Wearable Device Intervention

OTHER

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

Behavioral: Remote PCIT augmented with wearable devices

Interventions

Remote PCIT augmented with wearable devices 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

Wearable Device Intervention

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:

• 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.

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.
• Does not have the ability, technology, and/or internet access for remote therapy/research visits.
• 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 Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Problem Behavior

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Magdalena Romanowicz, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants will receive the same interventions
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 13, 2023
• Study Start: March 2, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)