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Recruiting NCT05725525

A Study of Internet Delivered Parent Child Interaction Therapy

Conditions: Disruptive Behavior

Sex: All
Ages: 3 Years – 99 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Mayo Clinic

Location: United States

Summary

The purpose of this study is to learn more about how feasible remote parent child interaction therapy (PCIT) is for children with disruptive behaviors and how to augment treatment with wearable devices.

Eligibility Criteria

Inclusion Criteria - Children (Aged 3-7):Outpatients.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).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;Must have the ability, technology, and internet access for remote therapy/research visits.Inclusion Criteria - Adults (Any age):Agree to wear Garmin watch.Able to provide informed consent.Able to speak and understand English.Has the ability, technology, and internet access for remote therapy/research visits.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.Does not have the ability, technology, and/or internet access for remote therapy/research visits.Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.Exclusion Criteria - Adults:Unable to speak and understand English.Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05725525). StuddyBuddy aggregates publicly available trial information.