Back to resultsA Study of Internet Delivered Parent Child Interaction Therapy (AI I-PCIT)
Primary Purpose
Disruptive Behavior
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote PCIT augmented with wearable devices
Sponsored by
About this trial
This is an interventional treatment trial for Disruptive Behavior focused on measuring Garmin Watch, Artificial Intelligence, PCIT, Telehealth, Technology, Decentralized 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.
Sites / Locations
- Mayo Clinic Minnesota
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Wearable Device Intervention
Arm Description
An open label, non randomized trial that requires all participants to wear a Garmin watch throughout the course of the trial (~12 weeks).
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Evaluating clinical improvement from remote PCIT in regards to sleep
The study will collect parental rating scale measures of their child's sleep (PSQ). These reports will be collected weekly and will be compared throughout the course of therapy to see if parental reports of sleep gets better (length of time child is in bed and sleeping increases by the end of therapy).
Evaluating clinical improvement from remote PCIT in regards to parental reports of behavior accuracy of indirect behavioral measures from wearable devices to parental ratings
The study will collect weekly parental ratings of their child's behavior (ECBI). These reports will be compared throughout the course of therapy to see if reports of the child's behavior is getting better throughout therapy.
Evaluating measured sleep data throughout remote PCIT
The Garmin device will measure sleep cycle data (deep sleep, light sleep, REM sleep and hours awake). This data will be analyzed throughout participation to see if overall sleep time and quality increases with the amount of time spent in therapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05725525
Brief Title
A Study of Internet Delivered Parent Child Interaction Therapy
Acronym
AI I-PCIT
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disruptive Behavior
Keywords
Garmin Watch, Artificial Intelligence, PCIT, Telehealth, Technology, Decentralized Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All participants will receive the same interventions
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wearable Device Intervention
Arm Type
Other
Arm Description
An open label, non randomized trial that requires all participants to wear a Garmin watch throughout the course of the trial (~12 weeks).
Intervention Type
Behavioral
Intervention Name(s)
Remote PCIT augmented with wearable devices
Intervention Description
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
Primary Outcome Measure Information:
Title
How wearing a Garmin watch will help the remote PCIT clinical outcomes
Description
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.
Time Frame
Through study completion, approximately 2 years
Title
Number of participants able to wear the Garmin watch throughout remote PCIT
Description
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.
Time Frame
Through study completion, approximately 2 years
Title
Evaluating parental acceptance of remote PCIT augmented with a Garmin device
Description
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.
Time Frame
Through study completion, approximately 2 years
Secondary Outcome Measure Information:
Title
Evaluating clinical improvement from remote PCIT in regards to sleep
Description
The study will collect parental rating scale measures of their child's sleep (PSQ). These reports will be collected weekly and will be compared throughout the course of therapy to see if parental reports of sleep gets better (length of time child is in bed and sleeping increases by the end of therapy).
Time Frame
Through study completion, approximately 2 years
Title
Evaluating clinical improvement from remote PCIT in regards to parental reports of behavior accuracy of indirect behavioral measures from wearable devices to parental ratings
Description
The study will collect weekly parental ratings of their child's behavior (ECBI). These reports will be compared throughout the course of therapy to see if reports of the child's behavior is getting better throughout therapy.
Time Frame
Through study completion, approximately 2 years
Title
Evaluating measured sleep data throughout remote PCIT
Description
The Garmin device will measure sleep cycle data (deep sleep, light sleep, REM sleep and hours awake). This data will be analyzed throughout participation to see if overall sleep time and quality increases with the amount of time spent in therapy.
Time Frame
Through study completion, approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Romanowicz, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Internet Delivered Parent Child Interaction Therapy
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