Virtual Reality (VR) Regulators

Emotion Regulation Clinical Trial

Official title:

VR Regulators: Teaching Adults to Manage Children's Big Emotions Through a Brief Virtual Reality Simulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184529
• Other study ID #: 20231355
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Jason Jent, PhD
• Phone: 3052436857
• Email: jjent[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• adults who do not speak English or Spanish

• adults with a history of significant motion sickness, active nausea, and vomiting or epilepsy

Related Conditions & MeSH terms

• Emotion Regulation

Intervention

Behavioral:
• Virtual Reality
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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	The Children's Trust, Miami FL

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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	Baseline, up to 10 minutes post-intervention, 1 month post-intervention
Secondary	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	up to 10 minutes post-intervention