NCT04025294

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

July 16, 2019

Last Update Submit

March 1, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • Measuring self-efficacy at baseline

    Participants will complete a pre-survey through a secured, data collection website (Qualtrics), before playing the videogame. Items from the general self-efficacy questionnaire will assess participants' self-efficacy at baseline. This scale uses a 5-point Likert response scale (1=Never, 2=Almost Never, 3=Sometimes, 4=Fairly Often, 5=Very Often). Total self-efficacy score ranges from 10-50.

    baseline

  • Change in self-efficacy from baseline

    Participants will complete a post-survey through a secured, data collection website (Qualtrics), immediately after playing the videogame. Items from the general self-efficacy questionnaire will assess participants' self-efficacy at baseline. This scale uses a 5-point Likert response scale (1=Never, 2=Almost Never, 3=Sometimes, 4=Fairly Often, 5=Very Often). Total self-efficacy score ranges from 10-50.

    immediately after playing the videogame

  • Measuring emotional self-efficacy at baseline

    Participants will complete a pre-survey through a secured, data collection website (Qualtrics), at baseline. Items from the Self-Efficacy Questionnaire for Children (SEQ-C) will assess participants' emotional self-efficacy immediately before playing the game. Each of the 6 items used in the study has to be scored on a 5-point scale with 1 = not at all and 5 = very well.

    baseline

  • Change in emotional self-efficacy from baseline

    Participants will complete a post-survey through a secured, data collection website (Qualtrics), at baseline. Items from the Self-Efficacy Questionnaire for Children (SEQ-C) will assess participants' emotional self-efficacy immediately after playing the game. Each of the 6 items used in the study has to be scored on a 5-point scale with 1 = not at all and 5 = very well.

    immediately after playing the videogame

  • Cognitive reappraisal scores at baseline

    Participants will complete a pre-survey through a secured, data collection website (Qualtrics), at baseline. The ERQ-CA includes 6 items assessing participants' cognitive appraisal. The scale length ranges up to five points with the following options: 1) strongly disagree; 2) disagree, 3) half and half, 4) agree, 5) strongly agree. The range of scores for each scale was 6 to 30.

    at baseline

  • Cognitive reappraisal scores at baseline

    Participants will complete a post-survey through a secured, data collection website (Qualtrics), immediately after playing the videogame. Items from the Emotional Regulation Questionnaire for Children and Adolescents (ERQ-CA) will assess participants' cognitive reappraisal immediately after playing the tool/game. The ERQ-CA includes 6 items assessing participants' cognitive appraisal. The scale length ranges up to five points with the following options: 1) strongly disagree; 2) disagree, 3) half and half, 4) agree, 5) strongly agree. The range of scores for each scale was 6 to 30.

    immediately after playing the videogame

Secondary Outcomes (2)

  • Gameplay post-assessment

    immediately after playing the game

  • School Climate

    Baseline

Study Arms (2)

Students playing videogame

EXPERIMENTAL

The experimental group will consist of our videogame intervention including the five mini-games.

Device: videogame

Students receiving school climate assessment

ACTIVE COMPARATOR

The control group differs from the experimental group as it includes the school climate assessment tool but excludes the mini-games

Behavioral: School Climate Assessment Survey

Interventions

videogameDEVICE

A videogame intervention that is interactive and engaging that teaches adolescents how to restructure negative automatic thoughts through an adapted thought record (a technique used in cognitive behavioral therapy to improve moods) by modeling how to do so and then empower them through real-life activities to improve their school climate. The videogame intervention is comprised of five mini-games, each containing a short narrative that models how to restructure negative automatic thoughts and navigate through challenging situations that often take place in school settings. The topics of each mini-game are informed by the constructs of school climate according to the National School Climate Center. Students using the videogame intervention will be prompted to think deeply and reflect on the narratives presented in each mini-game.

Students playing videogame

A school climate assessment survey will include items adapted from questions developed by the National School Climate Center. Items will assess various dimensions of school climate including safety, social media, relationships, support for learning, and environment.

Students receiving school climate assessment

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Those that do not meet the criteria above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Health & Learning Games

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Lynn E Fiellin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 18, 2019

Study Start

October 1, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations