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Garmin Monitoring for Disruptive Behaviors in Children 3-7 Years Old (PISTACHIo Trial)

N/A

Waitlist Available

Led By Paul Croarkin, DO, MS

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

PISTACHIo Trial Summary

This trial will use AI to monitor the sleep and behavior of 3-7 year old children in order to develop a better understanding of childhood sleep.

Eligible Conditions

ODD
Oppositional Defiant Disorder
Disruptive Behavior
Attention Deficit Hyperactivity Disorder (ADHD)

PISTACHIo Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of Garmin use

Secondary outcome measures

Eyberg Child Behavior Inventory

Pediatric Sleep Questionnaire

PISTACHIo Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AI Parent Child Interaction TherapyExperimental Treatment1 Intervention

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.

Group II: Sham Biometric - Parent Child Interaction TherapyPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Garmin

2022

N/A

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,040 Total Patients Enrolled

Paul Croarkin, DO, MSPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

Garmin Clinical Trial Eligibility Overview. Trial Name: NCT05077722 — N/A

ODD Research Study Groups: AI Parent Child Interaction Therapy, Sham Biometric - Parent Child Interaction Therapy

ODD Clinical Trial 2023: Garmin Highlights & Side Effects. Trial Name: NCT05077722 — N/A

Garmin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05077722 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial currently open?

"Per the information on clinicaltrials.gov, this medical investigation is in search of participants. The trial was initially posted online on March 22nd 2022 and last modified on April 4th 2022."

Answered by AI

Is the enrollment criteria for this research accommodating participants aged 80 or older?

"This clinical trial demands that patients be between the ages of 3 to 99. There are 63 slots designated for minors and an additional 63 spots available for seniors over 65."

Answered by AI

How many participants have enrolled in the clinical trial thus far?

"Affirmative. The facts posted on clinicaltrials.gov reveal that this medical research project, first publicized on March 22nd 2022, is actively recruiting participants. An estimated 100 patients are needed from 1 designated clinic centres."

Answered by AI

Which individuals are able to register for this research study?

"This study is recruiting 100 individuals aged 3-99 with defiant disorder, oppositional. Applicants must require intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization and have an ECBI severity rating above the clinically significant range (≥120; T-score ≥ 60). Participants of any gender, race or ethnicity are welcome -- both outpatients and inpatients alike -- provided they can commit to complete the treatment program."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence

Paul E. Croarkin 2022. "Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05077722.