- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02710019
Good Shepherd: Back to Reality Series
Back to Reality Series - Harry's Journey: A Video Game About Under Age
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project pilots the use of educational video games designed to help youth gain awareness of the risk of mental health issues associated with regular marijuana use. By playing the Back to Reality video games, youths may absorb knowledge about where and how to access community care for symptoms associated with psychosis and problematic cannabis use. The purpose of this study is to pilot test the use of the Back to Reality series at increasing awareness of the social and emotional implications of underage substance use.
This study explores the effects of the Back to Reality video games compared to control video games (no content about mental health and addiction). Street involved and homeless youth registered with Good Shepherd services between the ages of 16 and 19 years of age will be recruited. The results will be assessed using quantitative questionnaires and qualitative interviews. The data will be statistically analyzed for significant differences in knowledge about the risk of psychosis linked to marijuana use among vulnerable youth. The qualitative interview assesses the participants understanding and views of potential emotional, social, and psychiatric sequelae associated with excessive marijuana use during.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8R 2B3
- Good Shepherd
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Homeless or street involved youth
- Registered at any of the Good Shepherd Hamilton Youth programs
- Male, female, or transgender youth from 16-19 years of age as of visit 1.
- Outpatient status
- Each youth must understand the nature this study and sign informed consent
Exclusion Criteria:
- Youth judged by Good Shepherd staff to be at serious suicidal risk.
- Youth who are being discharged from Good Shepherd programming.
- Youth who are currently admitted in an in-patient unit at a hospital.
- Youth who scores 5 or more on the Video Game Playing Problems questionnaire (Teijeiro Salguero & Bersabé-Morán, 2002).
- Youth who do not have the capacity to provide informed consent.
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 |
|---|---|
|
Experimental: Psychoeducational video games
Participants in this group will play the Back to Reality Series video games: (1) Harry's Journey which delivers experiential knowledge about psychosis and marijuana use; (2) Harry's Journal which challenges their understanding of 12 psychiatric symptoms associated with psychosis and (3) the PathwaysToCare Map which uses colourful 3D images and voice-overs to depict actual mental health and addictions services for youth available in Hamilton.
These in
|
Back to Reality Series are a psycho-educational video games that provide information about psychosis and marijuana use from the perspective of 'Harry': a character who experiences problems with both issues.
The aim is for players to learn how to detect some signs of psychosis and where to seek help for mental health and addictions problems.
Other Names:
|
|
Other: Control video game
The control video game is a spelling/memory quiz involving with themes from pop culture.
The control game will not provide any education about mental health and addictions issues It should be noted that all participants will play both sets of games during their initial and only visit.
Participants are randomized to determine which game they will play first during this visit.
This is not an RCT or a crossover design.
There is no follow up or clinical assessments.
|
The control video game consists of digital puzzles and spelling game about pop culture.
The control games does not have any content related to mental health and addictions problems
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychosis and Cannabis Quiz
Time Frame: 1.5 hour -Post video game playing
|
Assess for significant differences in the responses between randomized intervention (Back to Reality series) group versus a control game group with respect to Psychosis and Cannabis Quiz measure.
Effect will be tested at a 2-sided α level of 0.05.
|
1.5 hour -Post video game playing
|
|
Early Psychosis Literacy
Time Frame: 1.5 hour -Post video game playing
|
Assess for significant differences in the responses between randomized intervention (Back to Reality series) group versus a control game group with respect to Early Psychosis Literacy measure.
Effect will be tested at a 2-sided α level of 0.05.
|
1.5 hour -Post video game playing
|
|
Video Game Frequency
Time Frame: 1.5 hour -Post video game playing
|
Assess for significant differences in the responses between randomized intervention (Back to Reality series) group versus a control game group with respect to Video Game Frequency measure.
Effect will be tested at a 2-sided α level of 0.05.
|
1.5 hour -Post video game playing
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Suzanne Archie, MD, McMaster University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- McMaster_University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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