Alcohol PreventionNCT04351958
An Augmented Reality Videogame for Alcohol Use Prevention and Harm Reduction in Teens
A study testing Experimental: Augmented Reality ("No Time Wasted") in people with Alcohol Prevention and Harm Reduction, run by Yale University at 1 site in United States.
Trial summary
The goal of this research study is to develop the AR-based alcohol use prevention and harm reduction intervention, "No Time Wasted", with the further aim of conducting a pre-post pilot study to assess whether the game reduce risk behaviors associated with alcohol use, whilst also increasing knowledge about some of the… Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Prevention, Harm Reduction
- What is being tested?
- Experimental: Augmented Reality ("No Time Wasted")
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants must be 16-18 years of age and currently enrolled in high school
- Speak English
- Able to play an AR videogame (willing use an AR headset for 30-45 minutes/session to play the game for the pilot study).
- Eligibility will be determined by the research team.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: An Augmented Reality Videogame for Alcohol Use Prevention and Harm
The goal of this research study is to develop the AR-based alcohol use prevention and harm reduction intervention, "No Time Wasted", with the further aim of conducting a pre-post pilot study to assess whether the game reduce risk behaviors associated with alcohol use, whilst also increasing knowledge about some of the following topics: BAC, standard drink sizes, signs of alcohol poisoning. The intervention will also seek to encourage bystander intervention to assist fictional characters in need of help due to overdrinking.
Read the detailed description
Specific Aim #1: DEVELOPMENT: A prototype of an augmented reality (AR) videogame intervention for alcohol use prevention and harm reduction in adolescents aged 16-18. Input from 4 focus groups of 5 adolescents each (n = 20), and the extant literature will inform the development of the AR videogame intervention, "No Time Wasted".
Specific Aim #2: PILOT EVALUATION: Conduct a pre-post pilot study with 20 teens ages 16-18 collecting assessment data at baseline and immediately following gameplay to assess
"No Time Wasted" will be an innovative, immersive intervention using novel technology that will captivate the target audience with narrative and gaming elements to scaffold the educational message. The proposed research will be conducted in two phases. Phase I consists of: (a) the development of the prototype using input from 4 focus groups of 5 adolescents each (n = 20), aged 16-18 and the extant literature (Specific Aim #1). In Phase II will consisted of a pre-post pilot study with 20 teens ages 16-18 collecting assessment data at baseline and immediately following gameplay to assess 1) the intervention's acceptability and feasibility by collecting quantitative and qualitative data on teens' satisfaction and gameplay experience of the intervention, and 2) the preliminary impact of the intervention on knowledge, intentions, perceptions, attitudes, social norms, self-efficacy and behaviors related to alcohol use and harm reduction.
Conduct focus groups to gather data to develop the AR videogame prototype, "No Time Wasted": Four focus groups will be conducted (5 adolescents each) to collect feedback on the game content, narrative, characters, and gameplay mechanics. To facilitate the discussions, visual tools (e.g., storyboards, pictures) will be used. The focus groups will be conducted according to standard dual-facilitator procedures. The four focus groups will be adequate to achieve thematic saturation. The focus groups will be conducted such that ideas and themes from one discussion inform discussion topics and prompts used in the next focus group. Audio recordings of each session will be transcribed, reviewed, and discussed by the research team to refine the videogame intervention. As a part of the game development and with parental permission, selected students will be invited to the Yale recording studio on campus to provide voices for the videogame characters.
Conduct a pre-post pilot study: This study will enroll 20 adolescents ages 16-18 using a pre/post design to evaluate the feasibility, acceptability, and preliminary efficacy of the AR videogame prototype. Participants will accumulate between 1- 1.5 hours of game play over 2 sessions (approximately one week, meeting twice). This total duration and number of sessions is consistent with those found in effective alcohol harm reduction and prevention interventions, which range from 10 minutes to 4 hours, and with the amount of time adolescents play videogames. Participants will have a 15-10 min break in the middle of each session and will be instructed that they may take additional breaks as needed.
- Conditions
- Alcohol Prevention, Harm Reduction
- Being tested
- Experimental: Augmented Reality ("No Time Wasted")
- Keywords
- videogame, augmented reality
- Medical subject headings
- Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Augmented Reality ("No Time Wasted")Behavioural
"No Time Wasted" will be an innovative, immersive intervention using novel technology that will captivate the target audience with narrative and gaming elements to scaffold the educational message.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality ("No Time Wasted") | Experimental | Not described Receives: Behavioral: Experimental: Augmented Reality ("No Time Wasted") |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine participants' satisfaction and gameplay experience
Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software). The survey includes 5 items on game experience and satisfaction from items designed for a previous videogame study on sexual risk reduction in young adolescents (e.g., "I would tell my friends to play this game," Questions have 5-point Likert-type choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.
Measured: End of gameplay - 2 hours
Secondary outcomes (7)
Behaviors with alcohol pretest
To determine the baseline alcohol use behavior and attitudes--pretest survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The 5 questions from the 2019 Youth Risk Behavior Survey (YRBS) that pertain to alcohol consumption will be used to assess participant alcohol use behavior. These items relate to frequency of drinking in the past 30 days (0-30), frequency of binge drinking in the past 30 days (0-20), and the maximum number of drinks consumed in a row in the last 30 days (1-10).
Measured: Baseline
Knowledge of alcohol pre-test
To determine the impact of an AR harm reduction and prevention videogame prototype, FREEZE!, on participants' knowledge about alcohol - Pre-test survey.
Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software), before playing the videogame intervention. A 12-item true/false/not sure block of questions will be developed to assess knowledge about alcohol information such as symptoms of alcohol poisoning, standard drink sizes, social host laws, common alcohol and drug interactions, and myths and misconceptions about alcohol.
Measured: Baseline
Knowledge of alcohol post-test
To determine the impact of an AR harm reduction and prevention videogame prototype, FREEZE!, on participants' knowledge about alcohol - Post-test survey. Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software), after playing the videogame intervention. A 12-item true/false/not sure block of questions will be developed to assess knowledge about alcohol information such as symptoms of alcohol poisoning, standard drink sizes, social host laws, common alcohol and drug interactions, and myths and misconceptions about alcohol.
Measured: End of gameplay - 2 hours
Intentions, attitudes, and social norms pre-test
Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software), before playing the videogame intervention.The Brief Adolescent Alcohol Expectancy Questionnaire (AEQ-AB) is designed to measure the degree to which individuals expect alcohol to produce a variety of general and specific effects. Research with the AEQ indicates a consistent relationship between alcohol expediencies and alcohol consumption, alcohol abuse and behavior while drinking. This questionnaire has 7 items that address intentions about drinking, attitudes towards both positive and negative components of alcohol consumption, and questions that address peer alcohol expectations and related social norms.
Measured: Baseline
Intentions, attitudes, and social norms post-test
Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software), after playing the videogame intervention.The Brief Adolescent Alcohol Expectancy Questionnaire (AEQ-AB) is designed to measure the degree to which individuals expect alcohol to produce a variety of general and specific effects. Research with the AEQ indicates a consistent relationship between alcohol expediencies and alcohol consumption, alcohol abuse and behavior while drinking. This questionnaire has 7 items that address intentions about drinking, attitudes towards both positive and negative components of alcohol consumption, and questions that address peer alcohol expectations and related social norms.
Measured: End of gameplay - 2 hours
Self-efficacy to refuse pre-test
Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software), before playing the videogame intervention.The 9-item Drinking Refusal Self-Efficacy Question are Shortened Revised Adolescent version (DRSEQ-SRA) is a shortened version of the DRSEQ-RA. It measures levels of drinking refusal self-efficacy, or confidence in an adolescent's ability to resist alcohol in cued situations. Responses are rated on a 6-point Likert scale (1 = I am very sure I could NOT resist drinking to 6 = I am very sure I could resist drinking). It comprises three subscales: Emotional relief refusal self-efficacy (3 items, e.g., 'When I feel sad'); Opportunistic refusal self-efficacy (3 items, e.g., 'When I am listening to music or reading'); Social pressure refusal self-efficacy (3 items, e.g., 'When my friends are drinking').
Measured: Baseline
Self-efficacy to refuse post-test
Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software), after playing the videogame intervention.The 9-item Drinking Refusal Self-Efficacy Question are Shortened Revised Adolescent version (DRSEQ-SRA) is a shortened version of the DRSEQ-RA. It measures levels of drinking refusal self-efficacy, or confidence in an adolescent's ability to resist alcohol in cued situations. Responses are rated on a 6-point Likert scale (1 = I am very sure I could NOT resist drinking to 6 = I am very sure I could resist drinking). It comprises three subscales: Emotional relief refusal self-efficacy (3 items, e.g., 'When I feel sad'); Opportunistic refusal self-efficacy (3 items, e.g., 'When I am listening to music or reading'); Social pressure refusal self-efficacy (3 items, e.g., 'When my friends are drinking').
Measured: End of gameplay - 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start12 Sep 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol PreventionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-Post Pilot Study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Hieftje, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351958
- Sponsor's protocol ID
- 2000027338
- Other IDs
- No NIH funding
- Status last verified
- Nov 2025
- First submitted
- 20 Feb 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Augmented Reality Videogame for Alcohol Use Prevention and Harm
- ClinicalTrials.gov ID
- NCT04351958
- Acronym / sponsor ID
- 2000027338
- Conditions
- Alcohol Prevention, Harm Reduction
- Keywords
- videogame, augmented reality
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 17 Apr 2020 (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.
The goal of this research study is to develop the AR-based alcohol use prevention and harm reduction intervention, "No Time Wasted", with the further aim of conducting a pre-post pilot study to assess whether the game reduce risk behaviors associated with alcohol use, whilst also increasing knowledge about some of the following topics: BAC, standard drink sizes, signs of alcohol poisoning. The intervention will also seek to encourage bystander intervention to assist fictional characters in need of help due to overdrinking.
Detailed description
Specific Aim #1: DEVELOPMENT: A prototype of an augmented reality (AR) videogame intervention for alcohol use prevention and harm reduction in adolescents aged 16-18. Input from 4 focus groups of 5 adolescents each (n = 20), and the extant literature will inform the development of the AR videogame intervention, "No Time Wasted".
Specific Aim #2: PILOT EVALUATION: Conduct a pre-post pilot study with 20 teens ages 16-18 collecting assessment data at baseline and immediately following gameplay to assess
"No Time Wasted" will be an innovative, immersive intervention using novel technology that will captivate the target audience with narrative and gaming elements to scaffold the educational message. The proposed research will be conducted in two phases. Phase I consists of: (a) the development of the prototype using input from 4 focus groups of 5 adolescents each (n = 20), aged 16-18 and the extant literature (Specific Aim #1). In Phase II will consisted of a pre-post pilot study with 20 teens ages 16-18 collecting assessment data at baseline and immediately following gameplay to assess 1) the intervention's acceptability and feasibility by collecting quantitative and qualitative data on teens' satisfaction and gameplay experience of the intervention, and 2) the preliminary impact of the intervention on knowledge, intentions, perceptions, attitudes, social norms, self-efficacy and behaviors related to alcohol use and harm reduction.
Conduct focus groups to gather data to develop the AR videogame prototype, "No Time Wasted": Four focus groups will be conducted (5 adolescents each) to collect feedback on the game content, narrative, characters, and gameplay mechanics. To facilitate the discussions, visual tools (e.g., storyboards, pictures) will be used. The focus groups will be conducted according to standard dual-facilitator procedures. The four focus groups will be adequate to achieve thematic saturation. The focus groups will be conducted such that ideas and themes from one discussion inform discussion topics and prompts used in the next focus group. Audio recordings of each session will be transcribed, reviewed, and discussed by the research team to refine the videogame intervention. As a part of the game development and with parental permission, selected students will be invited to the Yale recording studio on campus to provide voices for the videogame characters.
Conduct a pre-post pilot study: This study will enroll 20 adolescents ages 16-18 using a pre/post design to evaluate the feasibility, acceptability, and preliminary efficacy of the AR videogame prototype. Participants will accumulate between 1- 1.5 hours of game play over 2 sessions (approximately one week, meeting twice). This total duration and number of sessions is consistent with those found in effective alcohol harm reduction and prevention interventions, which range from 10 minutes to 4 hours, and with the amount of time adolescents play videogames. Participants will have a 15-10 min break in the middle of each session and will be instructed that they may take additional breaks as needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-Post Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality ("No Time Wasted") | Experimental | Behavioral: Experimental: Augmented Reality ("No Time Wasted") |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Participants must be 16-18 years of age and currently enrolled in high school
- Speak English
- Able to play an AR videogame (willing use an AR headset for 30-45 minutes/session to play the game for the pilot study).
- Eligibility will be determined by the research team.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Experimental: Augmented Reality ("No Time Wasted")"No Time Wasted" will be an innovative, immersive intervention using novel technology that will captivate the target audience with narrative and gaming elements to scaffold the educational message. | Behavioural | Augmented Reality ("No Time Wasted") |
Primary outcome
To determine participants' satisfaction and gameplay experience
Time frame: End of gameplay - 2 hours
Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software). The survey includes 5 items on game experience and satisfaction from items designed for a previous videogame study on sexual risk reduction in young adolescents (e.g., "I would tell my friends to play this game," Questions have 5-point Likert-type choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.
7 secondary outcomes
Behaviors with alcohol pretest
Time frame: Baseline
Knowledge of alcohol pre-test
Time frame: Baseline
Knowledge of alcohol post-test
Time frame: End of gameplay - 2 hours
Intentions, attitudes, and social norms pre-test
Time frame: Baseline
Intentions, attitudes, and social norms post-test
Time frame: End of gameplay - 2 hours
Self-efficacy to refuse pre-test
Time frame: Baseline
Self-efficacy to refuse post-test
Time frame: End of gameplay - 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Alcohol Prevention
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Active, not recruitingPhase 2
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
HIV, Heavy Drinking
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Not yet recruiting
A Hybrid Type 1 Randomized Controlled Trial of an Online and Text-Messaging Intervention to Prevent Alcohol and Cannabis Initiation, Escalation, and Consequences Among First-Year College Students
Alcohol, Cannabis
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
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.
Kimberly Hieftje, PhD 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 Experimental: Augmented Reality ("No Time Wasted") in people with Alcohol Prevention and Harm Reduction, 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 4 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: enrolling by invitation, as of the sponsor's last update on 18 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
To determine participants' satisfaction and gameplay experience (time frame: End of gameplay - 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.