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

Not Applicable

Completed

• Conditions: Disruptive Behavior; Oppositional Defiant Disorder; Attention-deficit Hyperactivity
• Interventions: Device: Garmin

• Registration Number: NCT05077722
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-14
• Study Start: 2022-03-24
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Biometric - Parent Child Interaction Therapy	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.
AI Parent Child Interaction Therapy	Garmin	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.

Primary Outcome Measures

Name	Time	Method
Frequency of Garmin use	12 weeks	Number of days participants wear the Garmin smartwatch

Secondary Outcome Measures

Name	Time	Method
Eyberg Child Behavior Inventory	12 weeks	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	12 weeks	Pediatric Sleep Questionnaire to assess child's sleep with a series of 22 questions on a yes/no problem scale.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States