Child Behavior DisordersNCT06474702
Predicting Violent Outburst in Inpatient Pediatric Psychiatry Ward Using a Wearable Device.
An observational study of Child Behavior Disorders, run by Sheba Medical Center.
Trial summary
The investigator will investigate the use of non-invasive wearable device physiological measures. this in order to predict aggression, and violence outburst in children under 12 years old, which are admitted at an inpatient psychiatric ward. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Child Behavior Disorders
- What is being tested?
- 'Fitbit charge 4' 'smart-watch'-
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2026
- Phase
- Observational
- 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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: children with mental ilnesses hospitalized at out inpatient psychiatric ward
Who may be able to join
- the investigator will include patients under the age of 13 with various mental disorders admitted to our inpatient psychiatry ward at 'Edmond and Lily Safra' Children's Hospital, Sheba Medical Centre, Tel Hashomer, Ramat Gan, Israel during 2024.
Who cannot join
- the investigator will exclude patients that were hospitalized but did not want to participate, or couldn't participate due to increased sensorial sensitive to the device. the investigator will exclude patients with no violence outburst or aggressive attitude that were hospitalized at our inpatient psychiatric ward during 2024. additional, patients who suffers dermatological illnesses and might show allergic reactions to the device material on their wrist will be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
The investigator will investigate the use of non-invasive wearable device physiological measures. this in order to predict aggression, and violence outburst in children under 12 years old, which are admitted at an inpatient psychiatric ward. also, the investigator will try to do a characterization of those physiological measures in the prediction of aggression and violence outbursts.
- Conditions
- Child Behavior Disorders
- Being tested
- 'Fitbit charge 4' 'smart-watch'-
- Medical subject headings
- Child Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Fitbit charge 4' 'smart-watch'-Device
smartwatch device that collects physiological measures
| Study group | Role | What they receive |
|---|---|---|
| study arm | the investigator will utilize "Fitbit-Charge 4" a wearable 'smart-watch' in order to collect patients' physiological measurements, including continuous heart rate, heart-rate variability and breathing rate, as well as behavioral measurements such as movements and sleep pattern in order to predict aggression and violence outburst in children under 12 years old admitted at an inpatient psychiatric ward and characterization of those physiological measures in the prediction of aggression and violence outbursts. Receives: Device: 'Fitbit charge 4' 'smart-watch'- |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological parameter
Heart rate
Measured: 12 months (july 2024-july 2025)
physiological parameter
heart rate variability, the data of heart rate variability is based on respiratory rate (outcome 3) and heart rate (outcome 1)
Measured: 12 months (july 2024-july 2025)
physiological parameter
respiratory rate
Measured: 12 months (july 2024-july 2025)
physiological parameter
sleep patterns, the data of sleep pattern is based on movements (outcome 5) and heart rate (outcome 1)
Measured: 12 months (july 2024-july 2025)
movements.
movements frequency of the patient, collected by the smart-watch using 3 axis-accelerometer that can detect movements in 3 dimensions. for example, number of steps taken.
Measured: 12 months (july 2024-july 2025)
Secondary outcomes (1)
violence assessment with 'MOAS' score system.
using 'MOAS', the Modified Overt Aggression Scale score system filled by the department staff manually on each day and outburst description. the score system is made up of four categories (verbal aggression, aggression against objects, aggression against self, and aggression against others. each category is ranked by numbers. range of total score is between 0-40. higher score usually higher than 20 indicating more aggressive behavior which means worse outcome.
Measured: 12 months (july 2024-july 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior DisordersStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Doron Gothelf MD, Sheba Medical Center
- Investigators
- Doron Gothelf, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474702
- Sponsor's protocol ID
- 1135-24-SMC
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 26 Jun 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Violent Outburst in Inpatient Pediatric Psychiatry Ward Using a Wearable Device.
- ClinicalTrials.gov ID
- NCT06474702
- Acronym / sponsor ID
- 1135-24-SMC
- Conditions
- Child Behavior Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 26 Jun 2024 (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 investigator will investigate the use of non-invasive wearable device physiological measures. this in order to predict aggression, and violence outburst in children under 12 years old, which are admitted at an inpatient psychiatric ward. also, the investigator will try to do a characterization of those physiological measures in the prediction of aggression and violence outbursts.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study arm | – | Device: 'Fitbit charge 4' 'smart-watch'-the investigator will utilize "Fitbit-Charge 4" a wearable 'smart-watch' in order to collect patients' physiological measurements, including continuous heart rate, heart-rate variability and breathing rate, as well as behavioral measurements such as movements and sleep pattern in order to predict aggression and violence outburst in children under 12 years old admitted at an inpatient psychiatric ward and characterization of those physiological measures in the prediction of aggression and violence outbursts. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with mental ilnesses hospitalized at out inpatient psychiatric ward
Key inclusion criteria (1 listed)
- the investigator will include patients under the age of 13 with various mental disorders admitted to our inpatient psychiatry ward at 'Edmond and Lily Safra' Children's Hospital, Sheba Medical Centre, Tel Hashomer, Ramat Gan, Israel during 2024.
Key exclusion criteria (1 listed)
- the investigator will exclude patients that were hospitalized but did not want to participate, or couldn't participate due to increased sensorial sensitive to the device. the investigator will exclude patients with no violence outburst or aggressive attitude that were hospitalized at our inpatient psychiatric ward during 2024. additional, patients who suffers dermatological illnesses and might show allergic reactions to the device material on their wrist will be excluded.
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 |
|---|---|---|
| 'Fitbit charge 4' 'smart-watch'-smartwatch device that collects physiological measures | Device | study arm |
Primary outcome
physiological parameter
Time frame: 12 months (july 2024-july 2025)
Heart rate
physiological parameter
Time frame: 12 months (july 2024-july 2025)
heart rate variability, the data of heart rate variability is based on respiratory rate (outcome 3) and heart rate (outcome 1)
physiological parameter
Time frame: 12 months (july 2024-july 2025)
respiratory rate
physiological parameter
Time frame: 12 months (july 2024-july 2025)
sleep patterns, the data of sleep pattern is based on movements (outcome 5) and heart rate (outcome 1)
movements.
Time frame: 12 months (july 2024-july 2025)
movements frequency of the patient, collected by the smart-watch using 3 axis-accelerometer that can detect movements in 3 dimensions. for example, number of steps taken.
1 secondary outcome
violence assessment with 'MOAS' score system.
Time frame: 12 months (july 2024-july 2025)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- 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.
Doron Gothelf, M.D principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Child Behavior Disorders, run by Sheba Medical Center.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doron Gothelf, M.D (+972526669360, doron.gothelf@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological parameter (time frame: 12 months (july 2024-july 2025)). The study lists 5 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 26 Jun 2024.