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OpenTrials
Completed

NCT Number: NCT05077722

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

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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Key information

Age range

3 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Frequency of Garmin use

    Time frame: 12 weeks

    Number of days participants wear the Garmin smartwatch

Secondary outcomes

  1. Eyberg Child Behavior Inventory

    Time frame: 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.

  2. Pediatric Sleep Questionnaire

    Time frame: 12 weeks

    Pediatric Sleep Questionnaire to assess child's sleep with a series of 22 questions on a yes/no problem scale.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Acronym: PISTACHIo

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2021
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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