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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI Parent Child Interaction Therapy | Experimental | 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. |
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| Sham Biometric - Parent Child Interaction Therapy | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Garmin | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Garmin use | Number of days participants wear the Garmin smartwatch | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria - Children:
Exclusion Criteria - Children:
Inclusion Criteria - Adults:
Exclusion Criteria - Adults:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Croarkin, DO, MS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41396603 | Derived | Romanowicz M, Saliba MT, Wilton AR, Garzon Hincapie JF, Croarkin KS, Saliba CT, LeMahieu A, Drapeau N, Schlichting B, Skime M, Bobo WV, Vande Voort JL, Shekunov J, Croarkin PE, Athreya AP. Feasibility of Digital Augmentation of Parent-Child Interaction Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548869. doi: 10.1001/jamanetworkopen.2025.48869. | |
| 36759915 |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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|
| 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. | 12 weeks |
| Derived |
| Saliba M, Drapeau N, Skime M, Hu X, Accardi CJ, Athreya AP, Kolacz J, Shekunov J, Jones DP, Croarkin PE, Romanowicz M. PISTACHIo (PreemptIon of diSrupTive behAvior in CHIldren): real-time monitoring of sleep and behavior of children 3-7 years old receiving parent-child interaction therapy augment with artificial intelligence - the study protocol, pilot study. Pilot Feasibility Stud. 2023 Feb 9;9(1):23. doi: 10.1186/s40814-023-01254-w. |
| ID | Term |
|---|---|
| D000066553 | Problem Behavior |
| D000096865 | Oppositional Defiant Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002652 | Child Behavior |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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