Disruptive BehaviorPISTACHIoNCT05077722
Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence
A study testing Garmin in people with Disruptive Behavior and Attention-deficit Hyperactivity, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Disruptive Behavior, Attention-deficit Hyperactivity, Oppositional Defiant Disorder
- What is being tested?
- Garmin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Agree to wear Garmin watch.
- Ages 18-99.
- Any gender, race, ethnicity.
- Able to provide informed consent.
Who cannot join
- 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.
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- Children in foster care.
- Unable to speak and understand English.
- Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official 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
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.
- Being tested
- Garmin
- Keywords
- Emotional Behavioral Dyscontrol
- Medical subject headings
- Problem Behavior, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GarminDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AI Parent Child Interaction Therapy | Experimental | Subjects enrolled in Parent Child Interaction Therapy (PCIT) will wear a Garmin smartwatch that will provided targeted messages during tantrums picked up by the Garmin devices that will instruct them on how to deescalate their child. Receives: Device: Garmin |
| Sham Biometric - Parent Child Interaction Therapy | Sham comparator | Subjects enrolled in Parent Child Interaction Therapy will wear Garmin smartwatch and will receive only random messages throughout the day with various relaxation strategies such as reminders to practice deep breathing with their child. Receives: Device: Garmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Garmin use
Number of days participants wear the Garmin smartwatch
Measured: 12 weeks
Secondary outcomes (2)
Eyberg Child Behavior Inventory
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.
Measured: 12 weeks
Pediatric Sleep Questionnaire
Pediatric Sleep Questionnaire to assess child's sleep with a series of 22 questions on a yes/no problem scale.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start24 Mar 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disruptive BehaviorStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul E. Croarkin, Mayo Clinic
- Investigators
- Paul Croarkin, DO, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077722
- Sponsor's protocol ID
- 21-007403
- Acronym
- PISTACHIo
- Status last verified
- Mar 2024
- First submitted
- 1 Oct 2021
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Romanowicz M, Saliba MT, Wilton AR, Garzon Hincapie JF, Croarkin KS, Saliba CT, LeMahieu A, Drapeau N, Schlichting B, Skime M, Bobo WV, Vande Voort JL, Shekunov J, Croarkin PE, Athreya AP. Feasibility of Digital Augmentation of Parent-Child Interaction Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548869. doi: 10.1001/jamanetworkopen.2025.48869.
PubMed 41396603Saliba M, Drapeau N, Skime M, Hu X, Accardi CJ, Athreya AP, Kolacz J, Shekunov J, Jones DP, Croarkin PE, Romanowicz M. PISTACHIo (PreemptIon of diSrupTive behAvior in CHIldren): real-time monitoring of sleep and behavior of children 3-7 years old receiving parent-child interaction therapy augment with artificial intelligence - the study protocol, pilot study. Pilot Feasibility Stud. 2023 Feb 9;9(1):23. doi: 10.1186/s40814-023-01254-w.
PubMed 36759915
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05077722
- Acronym / sponsor ID
- PISTACHIo / 21-007403
- Keywords
- Emotional Behavioral Dyscontrol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI Parent Child Interaction Therapy | Experimental | Device: GarminSubjects enrolled in Parent Child Interaction Therapy (PCIT) will wear a Garmin smartwatch that will provided targeted messages during tantrums picked up by the Garmin devices that will instruct them on how to deescalate their child. |
| Sham Biometric - Parent Child Interaction Therapy | Sham comparator | Device: GarminSubjects enrolled in Parent Child Interaction Therapy will wear Garmin smartwatch and will receive only random messages throughout the day with various relaxation strategies such as reminders to practice deep breathing with their child. |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GarminA 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. | Device | AI Parent Child Interaction Therapy, Sham Biometric - Parent Child Interaction Therapy |
Primary outcome
Frequency of Garmin use
Time frame: 12 weeks
Number of days participants wear the Garmin smartwatch
2 secondary outcomes
Eyberg Child Behavior Inventory
Time frame: 12 weeks
Pediatric Sleep Questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 41396603Romanowicz M, Saliba MT, Wilton AR, Garzon Hincapie JF, Croarkin KS, Saliba CT, LeMahieu A, Drapeau N, Schlichting B, Skime M, Bobo WV, Vande Voort JL, Shekunov J, Croarkin PE, Athreya AP. Feasibility of Digital Augmentation of Parent-Child Interaction Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548869. doi: 10.1001/jamanetworkopen.2025.48869.
- Derived from this study: PubMed 36759915Saliba M, Drapeau N, Skime M, Hu X, Accardi CJ, Athreya AP, Kolacz J, Shekunov J, Jones DP, Croarkin PE, Romanowicz M. PISTACHIo (PreemptIon of diSrupTive behAvior in CHIldren): real-time monitoring of sleep and behavior of children 3-7 years old receiving parent-child interaction therapy augment with artificial intelligence - the study protocol, pilot study. Pilot Feasibility Stud. 2023 Feb 9;9(1):23. doi: 10.1186/s40814-023-01254-w.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Croarkin, DO, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garmin in people with Disruptive Behavior and Attention-deficit Hyperactivity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Garmin use (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05077722, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.