Disruptive BehaviorAI I-PCITNCT05725525
A Study of Internet Delivered Parent Child Interaction Therapy
A study testing Remote PCIT augmented with wearable devices in people with Disruptive Behavior, run by Mayo Clinic at 1 site in United States.
Trial 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. 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
- What is being tested?
- Remote PCIT augmented with wearable devices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2023to 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
- 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.
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- 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.
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.
- 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.
- 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.
About this study
Official title: Feasibility of Internet Delivered Parent Child Interaction Therapy (AI I-PCIT) Real-Time Monitoring of Sleep and Behavior of Children 3-7 Years-Old Receiving Remote PCIT
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.
Read the detailed description
Children with disruptive behaviors aged 3-7 will wear a Garmin watch throughout the course of the study (approximately 12 weeks). Artificial Intelligence (AI) will be applied to analyze the vitals provided by the watch to monitor for disruptive behavior. Parent and child will be enrolled in remote PCIT sessions throughout the course of the trial. This study will not require any in person visits, all materials will be mailed to the patients home or sent electronically. The study will analyze how the use of a wearable device throughout PCIT will help increase the benefit to both parent and child as measured by biometrics via Garmin and by questionnaires preformed throughout the trial.
- Conditions
- Disruptive Behavior
- Being tested
- Remote PCIT augmented with wearable devices
- Keywords
- Garmin Watch, Artificial Intelligence, PCIT, Telehealth, Technology, Decentralized Trial
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote PCIT augmented with wearable devicesBehavioural
Participants will be enrolled in remote PCIT and be asked to wear a Garmin watch throughout the course of the study in order to measure biometric fluctuations
| Study group | Role | What they receive |
|---|---|---|
| Wearable Device Intervention | Other | An open label, non randomized trial that requires all participants to wear a Garmin watch throughout the course of the trial (~12 weeks). Receives: Behavioral: Remote PCIT augmented with wearable devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
How wearing a Garmin watch will help the remote PCIT clinical outcomes
Biometrics from the Garmin watch will be analyzed through Fitabase: step count, activity intensity, calories, heartrate, and respirations. This data will be compared throughout the study to see if factors trend down by the end of the trial. This would indicate that the child's behaviors were calmer at the end of the therapy when compared to the beginning.
Measured: Through study completion, approximately 2 years
Number of participants able to wear the Garmin watch throughout remote PCIT
The study will measure how often participants are wearing the device by monitoring two platforms that are paired with the watch: Fitabase and Ilumivu. These platforms inform the study team with wear time of the watch by the participant. A measurement of at least 70% of the time will be deemed feasible/acceptable for young patient's ability to wear the watch during therapy.
Measured: Through study completion, approximately 2 years
Evaluating parental acceptance of remote PCIT augmented with a Garmin device
At the end of therapy, the parent will receive an emailed survey asking about their opinions of the study technology and how it added to their child's therapy experience.
Measured: Through study completion, approximately 2 years
Secondary outcomes (3)
Evaluating clinical improvement from remote PCIT in regards to sleep
The study will collect parental rating scale measures of their child's sleep (PSQ). These reports will be collected weekly and will be compared throughout the course of therapy to see if parental reports of sleep gets better (length of time child is in bed and sleeping increases by the end of therapy).
Measured: Through study completion, approximately 2 years
Evaluating clinical improvement from remote PCIT in regards to parental reports of behavior accuracy of indirect behavioral measures from wearable devices to parental ratings
The study will collect weekly parental ratings of their child's behavior (ECBI). These reports will be compared throughout the course of therapy to see if reports of the child's behavior is getting better throughout therapy.
Measured: Through study completion, approximately 2 years
Evaluating measured sleep data throughout remote PCIT
The Garmin device will measure sleep cycle data (deep sleep, light sleep, REM sleep and hours awake). This data will be analyzed throughout participation to see if overall sleep time and quality increases with the amount of time spent in therapy.
Measured: Through study completion, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start2 Mar 2023
- 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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Romanowicz, Mayo Clinic
- Investigators
- Magdalena Romanowicz, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725525
- Sponsor's protocol ID
- 22-009425
- Acronym
- AI I-PCIT
- Status last verified
- Mar 2024
- First submitted
- 13 Jan 2023
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Internet Delivered Parent Child Interaction Therapy (AI I-PCIT) Real-Time Monitoring of Sleep and Behavior of Children 3-7 Years-Old Receiving Remote PCIT
- ClinicalTrials.gov ID
- NCT05725525
- Acronym / sponsor ID
- AI I-PCIT / 22-009425
- Conditions
- Disruptive Behavior
- Keywords
- Garmin Watch, Artificial Intelligence, PCIT, Telehealth, Technology, Decentralized Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 13 Feb 2023 (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 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.
Detailed description
Children with disruptive behaviors aged 3-7 will wear a Garmin watch throughout the course of the study (approximately 12 weeks). Artificial Intelligence (AI) will be applied to analyze the vitals provided by the watch to monitor for disruptive behavior. Parent and child will be enrolled in remote PCIT sessions throughout the course of the trial. This study will not require any in person visits, all materials will be mailed to the patients home or sent electronically. The study will analyze how the use of a wearable device throughout PCIT will help increase the benefit to both parent and child as measured by biometrics via Garmin and by questionnaires preformed throughout the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable Device Intervention | Other | Behavioral: Remote PCIT augmented with wearable devicesAn open label, non randomized trial that requires all participants to wear a Garmin watch throughout the course of the trial (~12 weeks). |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (11 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 |
|---|---|---|
| Remote PCIT augmented with wearable devicesParticipants will be enrolled in remote PCIT and be asked to wear a Garmin watch throughout the course of the study in order to measure biometric fluctuations | Behavioural | Wearable Device Intervention |
Primary outcome
How wearing a Garmin watch will help the remote PCIT clinical outcomes
Time frame: Through study completion, approximately 2 years
Biometrics from the Garmin watch will be analyzed through Fitabase: step count, activity intensity, calories, heartrate, and respirations. This data will be compared throughout the study to see if factors trend down by the end of the trial. This would indicate that the child's behaviors were calmer at the end of the therapy when compared to the beginning.
Number of participants able to wear the Garmin watch throughout remote PCIT
Time frame: Through study completion, approximately 2 years
The study will measure how often participants are wearing the device by monitoring two platforms that are paired with the watch: Fitabase and Ilumivu. These platforms inform the study team with wear time of the watch by the participant. A measurement of at least 70% of the time will be deemed feasible/acceptable for young patient's ability to wear the watch during therapy.
Evaluating parental acceptance of remote PCIT augmented with a Garmin device
Time frame: Through study completion, approximately 2 years
At the end of therapy, the parent will receive an emailed survey asking about their opinions of the study technology and how it added to their child's therapy experience.
3 secondary outcomes
Evaluating clinical improvement from remote PCIT in regards to sleep
Time frame: Through study completion, approximately 2 years
Evaluating clinical improvement from remote PCIT in regards to parental reports of behavior accuracy of indirect behavioral measures from wearable devices to parental ratings
Time frame: Through study completion, approximately 2 years
Evaluating measured sleep data throughout remote PCIT
Time frame: Through study completion, approximately 2 years
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 1 Apr 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Magdalena Romanowicz, MD 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 Remote PCIT augmented with wearable devices in people with Disruptive Behavior, 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 10 inclusion and 11 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 1 Apr 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. 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?
How wearing a Garmin watch will help the remote PCIT clinical outcomes (time frame: Through study completion, approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2024.