Clinical trial NCT04025294: The Evaluation of a School Climate Videogame Intervention
Official title: The Evaluation of a School Climate Videogame Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Reappraisal
Self Efficacy
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized control trial of a videogame intervention to assess and improve school climate.

Detailed description: To assess the acceptability and preliminary efficacy of a videogame intervention designed to teach teens the skills in restructuring thoughts and then empowering them to take action and improve their school climate.

For this project, the play2PREVENT Lab aims to assess the acceptability and preliminary efficacy of a videogame intervention designed to teach teens the skills in restructuring thoughts and then empowering them to take action and improve their school climate. Program and school staff will enroll participants between the ages of 14-19 years old to play our videogame during their after school programs. Before and after gameplay, participants will answer assessment questions related to self-efficacy, cognitive reappraisal, and dimensions of school climate. Questions will also assess participants' feedback on the videogame. Students not randomly assigned to the videogame intervention will only respond to assessment questions. The data will be transmitted electronically via Qualtrics data collection platform to the Lab for further analysis.

Eligibility criteria: Inclusion Criteria:

* Must be a current high school student
* English-speaking
* Willing to provide minor assent
* Willing to provide parental consent (if under 18 years old)
* Willing to play/use the game/tool for about 45 minutes to 1 hour after school
* Willing to answer questions about their experiences in playing the game, questions around school climate, and questions around self-efficacy on an iPad for about 30 minutes
* Willing to participate in an optional focus group for about 30 minutes

Exclusion Criteria:

* Those that do not meet the criteria above

Primary outcomes:
measure: Measuring self-efficacy at baseline
timeFrame: baseline
measure: Change in self-efficacy from baseline
timeFrame: immediately after playing the videogame
measure: Measuring emotional self-efficacy at baseline
timeFrame: baseline
measure: Change in emotional self-efficacy from baseline
timeFrame: immediately after playing the videogame
measure: Cognitive reappraisal scores at baseline
timeFrame: at baseline
measure: Cognitive reappraisal scores at baseline
timeFrame: immediately after playing the videogame
Secondary outcomes:
measure: Gameplay post-assessment
timeFrame: immediately after playing the game
measure: School Climate
timeFrame: Baseline
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Health & Learning Games
state: Connecticut
Study officials:
affiliation: Yale University
name: Lynn E Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandes CF, Deng Y, Tran AH, Hieftje KD, Boomer TMP, Taylor CK, Fiellin LE. A Pilot Randomized Controlled Trial to Evaluate a Cognitive Behavioral Videogame Intervention: empowerED. Games Health J. 2023 Feb;12(1):42-52. doi: 10.1089/g4h.2021.0118. Epub 2022 Nov 8.