Feasibility of Internet Delivered PCIT (AI I-PCIT)

Overview

About this study

The purpose of this study is to establish feasibility of a completely decentralized trial utilizing wearable devices to help implement therapy practices in a day to day setting.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Childre:

  • Ages 3-7.
  • Outpatients.
  • 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).
  • 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:

  • Agree to wear Garmin watch.
  • Ages 18-99.
  • Any gender, race, ethnicity.
  • 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.

Eligibility last updated  10/19/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Magdalena Romanowicz, M.D.

Open for enrollment

Contact information:

Noelle Drapeau

(507) 266-6397

Drapeau.Noelle2@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20542771

Mayo Clinic Footer