Harm Reduction Clinical Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05463341 -
Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties
|
N/A | |
| Recruiting |
NCT02425657 -
Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments
|
||
| Completed |
NCT04253158 -
Implementation of a Web-based Alcohol and Other Drug Prevention Intervention for Collegiate Student-athletes
|
N/A | |
| Active, not recruiting |
NCT04700930 -
CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia
|
N/A | |
| Recruiting |
NCT05994703 -
Assisting Smokers to Switch to an e-Cigarette by Accelerating Learning of Adaptive Habits Using D-cycloserine
|
Phase 2 | |
| Completed |
NCT04210180 -
Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction
|
Phase 2/Phase 3 | |
| Recruiting |
NCT06115746 -
A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
|
N/A | |
| Recruiting |
NCT05493475 -
Evaluation of a Novel Intervention to Prevent Polysubstance Overdoses Involving Illicit Stimulants
|
N/A | |
| Terminated |
NCT03675503 -
Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids
|
N/A | |
| Completed |
NCT01249339 -
In-vivo Extraction of Pb, Cd andTSNA From Swedish Snus
|
Phase 1 | |
| Completed |
NCT01369693 -
In-vivo Extraction of Pb, Cd and TSNA From Swedish Snus
|
Phase 1 | |
| Completed |
NCT01838473 -
In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Swedish 'Snus' in Regular Snus Users
|
Phase 1 | |
| Completed |
NCT04250727 -
Switching to Potential Reduced Exposure Products in Adult Smokers
|
N/A | |
| Completed |
NCT04650269 -
Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
|
Phase 4 | |
| Completed |
NCT04268173 -
Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3
|
Phase 3 | |
| Active, not recruiting |
NCT05404815 -
Exposure to Plasticisers in the Neonatal Intensive Care Unit
|
||
| Not yet recruiting |
NCT06429436 -
Vending Machine Naloxone Distribution for Your Community (VENDY)
|
Phase 4 | |
| Not yet recruiting |
NCT06372899 -
Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers
|
N/A | |
| Recruiting |
NCT05516069 -
Our Healthbox - Evaluating Interactive Dispensing Systems for Low-Barrier Access to HIV Testing and Harm Reduction.
|
N/A | |
| Completed |
NCT01130441 -
Self-harming Behaviors Study of Adolescents in a Juvenile Detention House
|
N/A |