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Good Shepherd: Back to Reality Series

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02710019
Recruitment Status : Unknown
Verified March 2016 by McMaster University.
Recruitment status was:  Not yet recruiting
First Posted : March 16, 2016
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
Good Shepherd Health Centre
Information provided by (Responsible Party):
McMaster University

Brief Summary:
The purpose of this study is to determine whether the Back to Reality series video games - Harry's Journey, Harry's Journal, and Pathways to care map - are effective at educating homeless and street involved youth, registered at the Youth Services Good Shepherd Hamilton, about the emotional, social, and psychiatric sequel of problematic underage substance use. The objectives of the video games are to promote early detection and awareness of mental health and substance use problems among youth.

Condition or disease Intervention/treatment Phase
Psychosis Other: Back to Reality Series video games Other: Control video games Not Applicable

Detailed Description:

This project examines the use of video game technology to help youth gain awareness of symptoms and problems associated with hazardous substance 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 effectiveness of the Back to Reality series at improving awareness of the social and emotional implications of underage substance use. Recognizing and overcoming hazardous substance use is essential for youth to develop positive self-identities and to flourish socially and academically. Improving mental health literacy may help youth to become better-informed consumers.

This study involves a randomized single blind controlled trial of video games along with a post-intervention mixed method design. The results will be assessed using quantitative questionnaires and qualitative interviews. The qualitative interview assesses the participants understanding of potential emotional, social, and psychiatric manifestations of excessive marijuana use during youth.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Back to Reality Series - Harry's Journey: A Video Game About Under Age
Study Start Date : April 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psychoeducational video games
Group 1 will play the Back to Reality video games series: (1) Harry's Journey which delivers experiential knowledge about psychiatric symptoms and substance use; (2) Harry's Journal which catalogs 12 symptoms associated with psychosis and (3) the PathwaysToCare Map which displays the mental health and addictions services located in Hamilton.
Other: Back to Reality Series video games
Back to Reality Series are a psycho-educational video games that address the emotional harms associated with underage substance use. They also help youth learn how and where to seek help for mental health and addictions problems.
Other Name: Computer video game intervention

Control video games (Group 2)
The control video games are a mix of mini-games, such as word search, quiz, and memory video games. The control games will not provide any education about mental health and addictions issues
Other: Control video games
The control video game will consist of digital puzzles and memory mini-games. The control games will not have any content related to mental health and addictions problems
Other Name: Computer video game control




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   16 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710019


Contacts
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Contact: Suzanne Archie, MD 905-522-1155 archies@mcmaster.ca

Locations
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Canada, Ontario
Cleghorn Program-Early Intervention in Psychosis.St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 1Y2
Sponsors and Collaborators
McMaster University
Good Shepherd Health Centre
Investigators
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Principal Investigator: Suzanne Archie, MD McMaster University

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02710019     History of Changes
Other Study ID Numbers: McMaster_University
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by McMaster University:
substance use
psychosis
youth
video game

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders