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

Oppositional Defiant Disorder Clinical Trial

— PISTACHIo  

Official title:

PISTACHIO (Preemption Of Disruptive Behavior In Children) Real-Time Monitoring Of Sleep And Behavior Of Children 3-7-Year-Old Receiving Parent Child Interaction Therapy Augmented With Artificial Intelligence Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077722
• Other study ID #: 21-007403
• Status: Completed
• Phase: N/A
• Start date: March 24, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 99 Years

Eligibility

Inclusion Criteria - Children:

• Ages 3-7.

• Outpatients or Inpatients.

• Any gender, race or ethnicity.

• Able to provide developmentally appropriate informed assent, and legal guardians able to provide informed consent .

• EBP Severity rated above the clinically significant range (=120; T-score = 60) (Eyberg Child Behavior Inventory- ECBI; Eyberg & Pincus, 1999).

• Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.

• Families approached for participation will be asked to commit to complete the treatment.

• At least one primary caregiver and the identified child will have to be able to speak and understand English.

Exclusion Criteria - Children:

• Formal diagnosis of Severe Intellectual disability, Autistic Spectrum Disorder Level 3, or a psychotic disorder for the child.

• Parents not consenting to the study.

• Parents or child is not able to adhere to the study protocol.

• A Child who is reasonable expected to be unable to tolerate wearing the Garmin device for at least 70% of the time during the day and night 70% of the days during the treatment (12 weeks). This is based on the principal investigator's discretion.

• Unable to speak and understand English.

• Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.

• Children in foster care.

Inclusion Criteria - Adults:

• Agree to wear Garmin watch.

• Ages 18-99.

• Any gender, race, ethnicity.

• Able to provide informed consent.

Exclusion Criteria - Adults:

• Unable to speak and understand English.

• Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.

Related Conditions & MeSH terms

• Attention-deficit Hyperactivity
• Disruptive Behavior
• Oppositional Defiant Disorder
• Problem Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Garmin use	Number of days participants wear the Garmin smartwatch	12 weeks
Secondary	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.	12 weeks
Secondary	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