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OpenTrials
Completed

NCT Number: NCT06184529

Virtual Reality (VR) Regulators

The purpose of this study is to test how well a virtual reality simulation helps adults learn new skills for managing children's emotions.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Satisfaction as measured by the Virtual Reality Satisfaction Survey

    Time frame: up to 10 minutes post-intervention

    Score ranges from 5-25 with higher scores representing higher satisfaction with the virtual reality simulation

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • The Children's Trust, Miami FL

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 28, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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