NCT04351958

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
5.4 years until next milestone

Study Start

First participant enrolled

September 12, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

February 20, 2020

Last Update Submit

November 14, 2025

Conditions

Keywords

videogameaugmented reality

Outcome Measures

Primary Outcomes (1)

  • 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.

    End of gameplay - 2 hours

Secondary Outcomes (7)

  • Behaviors with alcohol pretest

    Baseline

  • Knowledge of alcohol pre-test

    Baseline

  • Knowledge of alcohol post-test

    End of gameplay - 2 hours

  • Intentions, attitudes, and social norms pre-test

    Baseline

  • Intentions, attitudes, and social norms post-test

    End of gameplay - 2 hours

  • +2 more secondary outcomes

Study Arms (1)

Augmented Reality ("No Time Wasted")

EXPERIMENTAL
Behavioral: Experimental: Augmented Reality ("No Time Wasted")

Interventions

"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.

Augmented Reality ("No Time Wasted")

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Harm Reduction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kimberly Hieftje, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Pre-Post Pilot Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

April 17, 2020

Study Start

September 12, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations