Clinical trial NCT05077722: Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disruptive Behavior
Attention-deficit Hyperactivity
Oppositional Defiant Disorder
Keywords: Emotional Behavioral Dyscontrol
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Frequency of Garmin use
timeFrame: 12 weeks
Secondary outcomes:
measure: Eyberg Child Behavior Inventory
timeFrame: 12 weeks
measure: Pediatric Sleep Questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Paul Croarkin, DO, MS
role: PRINCIPAL_INVESTIGATOR
References: