KnowledgeNCT02710019
Good Shepherd: Back to Reality Series
A study testing Back to Reality Series Video Games in people with Knowledge, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of this pilot study is to explore whether the Back to Reality series of video games - Harry's Journey, Harry's Journal, and Pathways to care map - increase knowledge of the emotional, social, and psychiatric sequelae of problematic underage marijuana use among homeless and street involved youth. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Knowledge
- What is being tested?
- Back to Reality Series Video Games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 5 May 2016to 18 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Back to Reality Series - Harry's Journey: A Video Game About Under Age
The purpose of this pilot study is to explore whether the Back to Reality series of video games - Harry's Journey, Harry's Journal, and Pathways to care map - increase knowledge of the emotional, social, and psychiatric sequelae of problematic underage marijuana use among homeless and street involved youth. Additional objectives were to explore whether the video games promote awareness of the risk of psychosis associated with regular marijuana use among vulnerable youth.
Read the 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.
- Conditions
- Knowledge
- Being tested
- Back to Reality Series Video Games, Control Video Game
- Keywords
- marijuana use, psychosis, youth, video game
- Medical subject headings
- Marijuana Use, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back to Reality Series Video GamesOther
Also called Harry's Journal, Harry's Journey, Harry's PathwaysToCare map
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.
Control Video GameOther
Also called Morpheus' Spell
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
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational video games | Experimental | 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 Receives: Other: Back to Reality Series Video Games |
| Control video game | Other | 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. Receives: Other: Control Video Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosis and Cannabis Quiz
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.
Measured: 1.5 hour -Post video game playing
Early Psychosis Literacy
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.
Measured: 1.5 hour -Post video game playing
Video Game Frequency
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.
Measured: 1.5 hour -Post video game playing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study start5 May 2016
- Primary completion18 Apr 2017
- Study completion18 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KnowledgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Good Shepherd Health Centre
- Responsible party
- Sponsor
- Investigators
- Suzanne Archie, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710019
- Sponsor's protocol ID
- McMaster_University
- Status last verified
- Sep 2018
- First submitted
- 26 Feb 2016
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
PubMed 33539561
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back to Reality Series - Harry's Journey: A Video Game About Under Age
- ClinicalTrials.gov ID
- NCT02710019
- Acronym / sponsor ID
- McMaster_University
- Conditions
- Knowledge
- Keywords
- marijuana use, psychosis, youth, video game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Good Shepherd Health Centre
- Study start
- 5 May 2016 (actual)
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 18 Apr 2017 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to explore whether the Back to Reality series of video games - Harry's Journey, Harry's Journal, and Pathways to care map - increase knowledge of the emotional, social, and psychiatric sequelae of problematic underage marijuana use among homeless and street involved youth. Additional objectives were to explore whether the video games promote awareness of the risk of psychosis associated with regular marijuana use among vulnerable youth.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational video games | Experimental | Other: Back to Reality Series Video GamesParticipants 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 |
| Control video game | Other | Other: Control Video GameThe 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. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Back to Reality Series Video GamesAlso: Harry's Journal, Harry's Journey, Harry's PathwaysToCare mapBack 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 | Psychoeducational video games |
| Control Video GameAlso: Morpheus' SpellThe 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 | Control video game |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 33539561Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Archie, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back to Reality Series Video Games in people with Knowledge, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosis and Cannabis Quiz (time frame: 1.5 hour -Post video game playing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02710019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020; AzTrials last refreshed its copy on 29 Oct 2026.