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Remote PCIT for Disruptive Behavior (AI I-PCIT Trial)
N/A
Waitlist Available
Led By Magdalena Romanowicz, MD
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 through study completion, approximately 2 years
Awards & highlights
AI I-PCIT Trial Summary
This trial aims to see if remote PCIT therapy with wearables can help children with disruptive behaviors. #mentalhealth
Eligible Conditions
- Disruptive Behavior
AI I-PCIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluating parental acceptance of remote PCIT augmented with a Garmin device
How wearing a Garmin watch will help the remote PCIT clinical outcomes
Number of participants able to wear the Garmin watch throughout remote PCIT
Secondary outcome measures
Evaluating clinical improvement from remote PCIT in regards to parental reports of behavior accuracy of indirect behavioral measures from wearable devices to parental ratings
Evaluating clinical improvement from remote PCIT in regards to sleep
Evaluating measured sleep data throughout remote PCIT
AI I-PCIT Trial Design
1Treatment groups
Experimental Treatment
Group I: Wearable Device InterventionExperimental Treatment1 Intervention
An open label, non randomized trial that requires all participants to wear a Garmin watch throughout the course of the trial (~12 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remote PCIT augmented with wearable devices
2023
N/A
~10
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,242 Previous Clinical Trials
3,773,479 Total Patients Enrolled
1 Trials studying Disruptive Behavior
100 Patients Enrolled for Disruptive Behavior
Magdalena Romanowicz, MDPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be willing to wear a Garmin watch.You understand and agree to participate in the study.You have the necessary technology and internet access for remote therapy or research visits.Your child's behavior rating on the ECBI test is in the clinically significant range, which means it is concerning.You are able to receive treatment and go home the same day without needing to be hospitalized.The child and at least one primary caregiver must understand and speak English.You need to have a smartphone or computer with internet access to participate in remote visits.You can speak and understand English.You are able to understand and agree to participate in the study, and your legal guardians are able to give permission for you to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Wearable Device Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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