NCT02710019

Brief 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. Additional objectives were to explore whether the video games promote awareness of the risk of psychosis associated with regular marijuana use among vulnerable youth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 5, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2017

Completed
Last Updated

November 9, 2020

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

February 26, 2016

Last Update Submit

November 5, 2020

Conditions

Keywords

marijuana usepsychosisyouthvideo game

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    1.5 hour -Post video game playing

Study Arms (2)

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

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.

Other: Control Video Game

Interventions

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.

Also known as: Harry's Journal, Harry's Journey, Harry's PathwaysToCare map
Psychoeducational video games

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

Also known as: Morpheus' Spell
Control video game

Eligibility Criteria

Age16 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Shepherd

Hamilton, Ontario, L8R 2B3, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Marijuana UsePsychotic Disorders

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Suzanne Archie, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 16, 2016

Study Start

May 5, 2016

Primary Completion

April 18, 2017

Study Completion

April 18, 2017

Last Updated

November 9, 2020

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations