Cognitive ReappraisalNCT04025294
The Evaluation of a School Climate Videogame Intervention
A study testing videogame and School Climate Assessment Survey in people with Cognitive Reappraisal and Self Efficacy, run by Yale University at 1 site in United States.
Trial summary
A randomized control trial of a videogame intervention to assess and improve school climate. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Reappraisal, Self Efficacy
- What is being tested?
- videogame and School Climate Assessment Survey
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Those that do not meet the criteria above
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Center for Health & Learning Games
New Haven, Connecticut, 06510
About this study
A randomized control trial of a videogame intervention to assess and improve school climate.
Read the 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.
- Conditions
- Cognitive Reappraisal, Self Efficacy
- Being tested
- videogame, School Climate Assessment Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
School Climate Assessment SurveyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Students playing videogame | Experimental | The experimental group will consist of our videogame intervention including the five mini-games. Receives: 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 Receives: Behavioral: School Climate Assessment Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately after playing the videogame
Secondary outcomes (2)
Gameplay post-assessment
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.
Measured: immediately after playing the game
School Climate
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Oct 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ReappraisalStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynn E Fiellin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025294
- Sponsor's protocol ID
- 2000026033
- Status last verified
- Mar 2021
- First submitted
- 16 Jul 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36350349
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a School Climate Videogame Intervention
- ClinicalTrials.gov ID
- NCT04025294
- Acronym / sponsor ID
- 2000026033
- Conditions
- Cognitive Reappraisal, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Students playing videogame | Experimental | Device: videogameThe experimental group will consist of our videogame intervention including the five mini-games. |
| Students receiving school climate assessment | Active comparator | Behavioral: School Climate Assessment SurveyThe control group differs from the experimental group as it includes the school climate assessment tool but excludes the mini-games |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Those that do not meet the criteria above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| videogameA 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. | Device | Students playing videogame |
| School Climate Assessment SurveyA 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. | Behavioural | Students receiving school climate assessment |
Primary outcome
Measuring self-efficacy at baseline
Time frame: 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.
Change in self-efficacy from baseline
Time frame: immediately after playing the videogame
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.
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.
Change in emotional self-efficacy from baseline
Time frame: immediately after playing the videogame
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.
Cognitive reappraisal scores at baseline
Time frame: 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.
Cognitive reappraisal scores at baseline
Time frame: immediately after playing the videogame
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.
2 secondary outcomes
Gameplay post-assessment
Time frame: immediately after playing the game
School Climate
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 36350349Fernandes 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.
- Individual participant dataSharing planned: Undecided
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Transforming Adolescent Perception and Mental Health Through Meditation and Cognitive Reappraisal A Mixed Method Study
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An Ecological Momentary Intervention for the Reduction of Impairment in Somatic Symptom Disorder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn E Fiellin, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing videogame and School Climate Assessment Survey in people with Cognitive Reappraisal and Self Efficacy, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring self-efficacy at baseline (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.