Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction The… (NCT05077722) | Clinical Trial Compass
CompletedNot Applicable
Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence
United States100 participantsStarted 2022-03-24
Plain-language 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.
Who can participate
Age range3 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, e…