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

Mayo Clinic

Status: Completed

Conditions: Attention-deficit Hyperactivity; Oppositional Defiant Disorder; Disruptive Behavior

Treatments: Device: Garmin

Study type: Interventional

Funder types: Other

Identifiers

NCT05077722

21-007403

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 3 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

AI Parent Child Interaction Therapy

Experimental group

Description:

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.

Treatment:

Device: Garmin

Sham Biometric - Parent Child Interaction Therapy

Sham Comparator group

Description:

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.

Treatment:

Device: Garmin