Clinical trial NCT04351958: An Augmented Reality Videogame for Alcohol Use Prevention and Harm Reduction in Teens
Official title: An Augmented Reality Videogame for Alcohol Use Prevention and Harm
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Prevention
Harm Reduction
Keywords: videogame
augmented reality
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-Post Pilot Study
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

-

Primary outcomes:
measure: To determine participants' satisfaction and gameplay experience
timeFrame: End of gameplay - 2 hours
Secondary outcomes:
measure: Behaviors with alcohol pretest
timeFrame: Baseline
measure: Knowledge of alcohol pre-test
timeFrame: Baseline
measure: Knowledge of alcohol post-test
timeFrame: End of gameplay - 2 hours
measure: Intentions, attitudes, and social norms pre-test
timeFrame: Baseline
measure: Intentions, attitudes, and social norms post-test
timeFrame: End of gameplay - 2 hours
measure: Self-efficacy to refuse pre-test
timeFrame: Baseline
measure: Self-efficacy to refuse post-test
timeFrame: End of gameplay - 2 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Kimberly Hieftje, PhD
role: PRINCIPAL_INVESTIGATOR
References: