Emotion RegulationNCT06184529
Virtual Reality (VR) Regulators
A study testing Virtual Reality in people with Emotion Regulation, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to test how well a virtual reality simulation helps adults learn new skills for managing children's emotions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2024to 30 Aug 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult 18 years old or higher AND
- Caregiver of a child ages 3-6 years old OR educator or child allied health or medical professional that regularly works with children ages 3-6 years old
Who cannot join
- adults who do not speak English or Spanish
- adults with a history of significant motion sickness, active nausea, and vomiting or epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VR Regulators: Teaching Adults to Manage Children's Big Emotions Through a Brief Virtual Reality Simulation
The purpose of this study is to test how well a virtual reality simulation helps adults learn new skills for managing children's emotions.
- Conditions
- Emotion Regulation
- Being tested
- Virtual Reality
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
The virtual reality simulation includes a one time viewing of a brief video tutorial and then trying out a one time virtual reality simulation with a child avatar that takes 10-20 minutes to complete in-person.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Participants in this group will receive the virtual reality simulation for up to 6 weeks. Receives: Behavioral: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult Emotion Regulation as measured by the Difficulties in Emotion Regulation Scale
Score ranges from 18-90 with higher scores representing more problems with emotion regulation.
Measured: Baseline
Changes in adult responses to child emotions as measured by the Adult Responses to Young Children's Strong Emotions Scale
Score ranges from 7-35 with higher scores representing a higher frequency of reported or planned use of adaptive emotion regulation responses to children
Measured: Baseline, up to 10 minutes post-intervention, 1 month post-intervention
Secondary outcomes (1)
Satisfaction as measured by the Virtual Reality Satisfaction Survey
Score ranges from 5-25 with higher scores representing higher satisfaction with the virtual reality simulation
Measured: up to 10 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start21 Feb 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Trust, Miami FL
- Responsible party
- Principal investigator, Jason Jent, University of Miami
- Investigators
- Jason Jent, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184529
- Sponsor's protocol ID
- 20231355
- Status last verified
- Sep 2024
- First submitted
- 14 Dec 2023
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR Regulators: Teaching Adults to Manage Children's Big Emotions Through a Brief Virtual Reality Simulation
- ClinicalTrials.gov ID
- NCT06184529
- Acronym / sponsor ID
- 20231355
- Conditions
- Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Children's Trust, Miami FL
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 28 Dec 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 test how well a virtual reality simulation helps adults learn new skills for managing children's emotions.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Behavioral: Virtual RealityParticipants in this group will receive the virtual reality simulation for up to 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult 18 years old or higher AND
- Caregiver of a child ages 3-6 years old OR educator or child allied health or medical professional that regularly works with children ages 3-6 years old
Key exclusion criteria (2 listed)
- adults who do not speak English or Spanish
- adults with a history of significant motion sickness, active nausea, and vomiting or epilepsy
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 |
|---|---|---|
| Virtual RealityThe virtual reality simulation includes a one time viewing of a brief video tutorial and then trying out a one time virtual reality simulation with a child avatar that takes 10-20 minutes to complete in-person. | Behavioural | Virtual Reality Group |
Primary outcome
Adult Emotion Regulation as measured by the Difficulties in Emotion Regulation Scale
Time frame: Baseline
Score ranges from 18-90 with higher scores representing more problems with emotion regulation.
Changes in adult responses to child emotions as measured by the Adult Responses to Young Children's Strong Emotions Scale
Time frame: Baseline, up to 10 minutes post-intervention, 1 month post-intervention
Score ranges from 7-35 with higher scores representing a higher frequency of reported or planned use of adaptive emotion regulation responses to children
1 secondary outcome
Satisfaction as measured by the Virtual Reality Satisfaction Survey
Time frame: up to 10 minutes post-intervention
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 19 Sep 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.
Jason Jent, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Emotion Regulation, run by University of Miami 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 2 inclusion and 2 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 19 Sep 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?
Adult Emotion Regulation as measured by the Difficulties in Emotion Regulation Scale (time frame: Baseline). The study lists 2 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 19 Sep 2024.