Virtual Reality (VR) Regulators

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.

Study Overview

• Status: Recruiting
• Conditions: Emotion Regulation
• Intervention / Treatment: Behavioral: Virtual Reality

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason Jent, PhD; Phone Number: 3052436857; Email: jjent@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Jason Jent, PhD
      • Contact: Jason Jent, PhD; Phone Number: 305-243-6857; Email: jjent@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; Participants in this group will receive the virtual reality simulation for up to 6 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: The Children's Trust, Miami FL
• Investigators: Principal Investigator: Jason Jent, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20231355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No