An interventional study of Garmin in Disruptive Behavior, Attention-deficit Hyperactivity and Oppositional Defiant Disorder, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 3 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
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.
178 studies on the registry are indexed under Problem Behavior; 47 are open to participants now.
This study's enrollment of 100 is above the median of 90 across 165 interventional studies indexed under Problem Behavior.
Browse Problem Behavior studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria - Children:
Exclusion Criteria - Children:
Inclusion Criteria - Adults:
Exclusion Criteria - Adults:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Garmin
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.
Device: Garmin
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.
Frequency of Garmin use
Number of days participants wear the Garmin smartwatch
Time frame: 12 weeks
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.
Time frame: 12 weeks
Pediatric Sleep Questionnaire
Pediatric Sleep Questionnaire to assess child's sleep with a series of 22 questions on a yes/no problem scale.
Time frame: 12 weeks
Ran from Mar 2022 to primary completion in Dec 2023, 20 months.
Of 111 non-industry interventional studies with no phase under Problem Behavior, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's 20 months is below that.
Counting every sponsor, half of 112 studies reached it within 24 months; a quarter within 13 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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