- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04025294
The Evaluation of a School Climate Videogame Intervention
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale Center for Health & Learning Games
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Students playing videogame
The experimental group will consist of our videogame intervention including the five mini-games.
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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.
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Active Comparator: Students receiving school climate assessment
The control group differs from the experimental group as it includes the school climate assessment tool but excludes the mini-games
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring self-efficacy at baseline
Time Frame: baseline
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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.
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baseline
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Change in self-efficacy from baseline
Time Frame: immediately after playing the videogame
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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
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Measuring emotional self-efficacy at baseline
Time Frame: 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.
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baseline
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Change in emotional self-efficacy from baseline
Time Frame: immediately after playing the videogame
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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.
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immediately after playing the videogame
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Cognitive reappraisal scores at baseline
Time Frame: at baseline
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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
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Cognitive reappraisal scores at baseline
Time Frame: immediately after playing the videogame
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gameplay post-assessment
Time Frame: immediately after playing the game
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Participants will complete a post-survey through a secured, data collection website (Qualtrics), immediately after playing the game.
Twelve items will assess intervention experience and satisfaction from items designed by members of the study team (e.g., How likely do you think completing any of the activities will help you improve how you feel about yourself, others, or social situations?
Response options include very likely, likely, might or might not, unlikely, very unlikely.)
These questions are not part of a larger scale.
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immediately after playing the game
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School Climate
Time Frame: Baseline
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Participants will complete a pre-survey through a secured, data collection website (Qualtrics), immediately before playing the videogame.
Items from the National School Climate Center will be adapted and used to assess dimensions of participants' school climate, including safety, support for learning, environment, social media, and relationships.
Response options include yes, no, not applicable.
These questions are not part of a larger scale.
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Baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2000026033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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