Back to resultsMonitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence (PISTACHIo)
Primary Purpose
Disruptive Behavior, Attention-deficit Hyperactivity, Oppositional Defiant Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Garmin
Sponsored by
About this trial
This is an interventional supportive care trial for Disruptive Behavior focused on measuring Emotional Behavioral Dyscontrol
Eligibility Criteria
Inclusion Criteria - Children:
- 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).
- Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.
- 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.
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.
Inclusion Criteria - Adults:
- Agree to wear Garmin watch.
- Ages 18-99.
- Any gender, race, ethnicity.
- Able to provide informed consent.
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 in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
AI Parent Child Interaction Therapy
Sham Biometric - Parent Child Interaction Therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Frequency of Garmin use
Number of days participants wear the Garmin smartwatch
Secondary Outcome Measures
Eyberg Child Behavior Inventory
The Eyberg Child Behavior Inventory questionnaire is measured on two subscales for a series of phrases that describe a children's behavior. The first subscale is for indicating the frequency of the behavior using a scale of 1= never to 7 = Always; the second subscale indicates yes = 1 or no = 0 for whether the behavior is currently a problem for them. Reponses are total with a higher score indicating greater severity of child's behavior.
Pediatric Sleep Questionnaire
Pediatric Sleep Questionnaire to assess child's sleep with a series of 22 questions on a yes/no problem scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05077722
Brief Title
Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence
Acronym
PISTACHIo
Official Title
PISTACHIO (Preemption Of Disruptive Behavior In Children) Real-Time Monitoring Of Sleep And Behavior Of Children 3-7-Year-Old Receiving Parent Child Interaction Therapy Augmented With Artificial Intelligence Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 24, 2022 (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 develop an innovative wearable tracking protocol that will use Artificial Intelligence (AI) technology to monitor sleep and behavior of 3-7 year old children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disruptive Behavior, Attention-deficit Hyperactivity, Oppositional Defiant Disorder
Keywords
Emotional Behavioral Dyscontrol
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AI Parent Child Interaction Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Biometric - Parent Child Interaction Therapy
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Garmin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of Garmin use
Description
Number of days participants wear the Garmin smartwatch
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Eyberg Child Behavior Inventory
Description
The Eyberg Child Behavior Inventory questionnaire is measured on two subscales for a series of phrases that describe a children's behavior. The first subscale is for indicating the frequency of the behavior using a scale of 1= never to 7 = Always; the second subscale indicates yes = 1 or no = 0 for whether the behavior is currently a problem for them. Reponses are total with a higher score indicating greater severity of child's behavior.
Time Frame
12 weeks
Title
Pediatric Sleep Questionnaire
Description
Pediatric Sleep Questionnaire to assess child's sleep with a series of 22 questions on a yes/no problem scale.
Time Frame
12 weeks
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:
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).
Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.
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.
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.
Inclusion Criteria - Adults:
Agree to wear Garmin watch.
Ages 18-99.
Any gender, race, ethnicity.
Able to provide informed consent.
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
Paul Croarkin, DO, MS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence
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