- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06727786
Serious Game to Teach Opioid Overdose Response
Using a Serious Game to Teach People How to Recognize and Respond to Opioid Overdose
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study uses an interactive realistic film depicting an opioid overdose to teach high school/middle school students how to recognize and respond to opioid overdose. The film features a person who finds their friend unresponsive, with evidence of opioid use. The unresponsive friend demonstrates signs of opioid overdose. The hero must recognize opioid overdose, administer naloxone (opioid antedote) and perform CPR. The film is made interactive by the narrator pausing the action of the film, and asking learners to answer questions/make choices.
Efficacy is tested on the day of training, and 2-4 months later. Efficacy is measured by student ability to correctly administer naloxone to a manikin, perform CPR, and answer knowledge questions about opioid overdose. Other studied metrics include student engagement/enjoyment, attitudes/biases, and emotions created by the training. These will be tested through validated questionnaires.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Associate Professor, MD
- Phone Number: 7756828239
- Email: ltoft@unr.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Student at participating school, enrolled in Health or Science Class
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No intervention/training
|
|
|
Experimental: Serious Game
Serious Game training to respond to opioid overdose
|
A serious game featuring a dramatic/realistic film, pauses with questions for active learning, and practice administration of naloxone and performing CPR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Naloxone administration Skill
Time Frame: Day of training, and 2-3 months
|
Properly administer naloxone to a victim of opioid overdose Study personnel will ask students to administer naloxone to a CPR manikin.
Personnel will use a checklist from the Center for Addiction and Mental Health to score student responses.
|
Day of training, and 2-3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CPR Skill
Time Frame: Day of training, and 2-3 months
|
Ability to perform high-quality CPR Students will be asked to perform CPR on a CPR manikin for 2 minutes.
CPR skill will be measured with the CPR Meter 2 from Laerdal, which reports compression rate, depth, and percent recoil.
We will consider "high quality CPR" students who perform 70% or more of compressions at appropriate rate (100-120/min), depth (2-2.5inches), and full recoil.
|
Day of training, and 2-3 months
|
|
Attitudes towards opioid overdose
Time Frame: Day of training, and 2-3 months
|
Attitudes, enjoyment, and emotions towards opioid overdose Emotions will be measured using the PANAS scale (Positive And Negative Affect Scale) which consists of 10 positive and 10 negative emotion words. The total score is calculated by finding the sum of the 10 positive items, and then the 10 negative items. Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect. Engagement and enjoyment will be measured using Likert-style questions asking for agreement with statements such as "I enjoyed CPR training," "CPR training was fun," "I will use CPR training in the future," "It is important to learn CPR" Attitudes will be measured with a custom questionnaire asking Likert-style responses to statements regarding opioid overdose. |
Day of training, and 2-3 months
|
|
Knowledge of opioid overdose response
Time Frame: Day of training, and 2-3 months
|
Knowledge of how to recognize and respond to opioid overdose A questionnaire of custom-created multiple choice questions will assess student knowledge of how to recognize and respond to opioid overdose.
|
Day of training, and 2-3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2159620
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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