A Study Of PISTACHIO 2.0
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 25-007214
About this study
The purpose of this study is to develop generative algorithms with closed-loop feedback using 5.4 million minutes of smartwatch data collected from 50 children (aged 3 – 7 years) and parent-provided timestamps (closed-loop feedback) of disruptive behavior (characterized by temper outbursts).
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: Children
Ages 3-7 at time of enrolment.
Outpatients
Any gender, race, or ethnicity.
Able to provide developmentally appropriate informed assent, and parents or 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.
To be able to speak and understand English and willing to wear a smartwatch.
Children included in the study will be allowed to use psychotropic medications (such as stimulants for ADHD) during the trial monitored by their clinician (combined treatment).
Exclusion Criteria: Children
Formal diagnosis of Severe Intellectual disability, Severe Autistic Spectrum Disorder, or a psychotic disorder for the child.
Parents not consenting to 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.
Any unstable medical condition.
Use of any investigational drug within 4 weeks of baseline.
Inclusion Criteria Adults (Parents or legal caregiver):
Agree to wear Garmin watch
Ages 18-99
Any gender, race, ethnicity.
Able to provide informed consent.
To be able to speak and understand English.
Exclusion Criteria Adults (Parents or legal caregiver):
Unable to speak and understand English.
Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
Any unstable medical/psychiatric condition.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 6/27/2025. 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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Magdalena Romanowicz, M.D. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available