- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05702086
Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression
Evaluating the Utility of a Psychoeducational Serious Game (SPARX) in Protecting Inuit Youth From Depression: A Pilot Study
The goal of this pilot trial was to test SPARX with Inuit youth in Northern Canada. SPARX is an educational video game designed to teach cognitive behavioural therapy strategies and techniques. This "serious game" has previously shown promise in addressing symptoms of depression with Māori youth in New Zealand. Researchers in this study tested SPARX's suitability with Inuit youth in the territory of Nunavut using surveys that youth completed before and after gameplay.
Hypothesis 1: Youth who completed SPARX were expected to experience a decrease in depressive symptoms and risk factors related to depression. Hypothesis 2: Youth who completed the SPARX program were expected to experience an increase in factors related to resilience.
A team of Nunavut-based community mental health staff facilitated youth's participation in this remote pilot trial with 24 youth aged 13-18 across 11 communities in Nunavut. These youth had been identified by community facilitators as showing low mood, depression, and/or significant levels of stress.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M3J 1P3
- York University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants had been identified by the community facilitators as exhibiting low mood, negative affect, depressive presentations, and/or significant levels of stress. Youth had to demonstrate sufficient English language comprehension to use and understand SPARX
Exclusion Criteria:
- Initially, youth were excluded if they showed limited cognitive abilities, psychotic presentation, severe depression, or elevated suicide risk, or if they were currently receiving or had previously received CBT, Interpersonal Therapy (IPT), or antidepressant medication within the past three months. However, due to safety and ethics concerns about vulnerable youth feeling left out, at the discretion of local mental health experts on the team, these exclusion criteria were relaxed.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: "Play now" intervention group
The sequence of SPARX play differed for the youth depending on whether they were in Group A ("play now" intervention group) or Group B ("play later" waitlist group).
Both groups completed the pre-intervention surveys at Time 1, the beginning of the study.
Group A youth then began to play SPARX for seven weeks while Group B waited.
During their wait time of seven weeks, Group B youth were not required to participate in any SPARX activities or meet with the community facilitator during their wait period, and they were provided with no additional SPARX-related information.
After seven weeks (Time 2), Group A youth completed post-intervention surveys, while Group B youth began their engagement with SPARX by first completing an additional set of pre-intervention surveys, immediately followed by seven weeks of SPARX play.
Once Group B youth completed their SPARX gameplay (Time 3), they completed post-intervention surveys.
|
SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts) is a psychoeducational serious game (an e-intervention that utilizes gaming for serious purposes) that teaches established cognitive behavioural therapy strategies and techniques across seven levels or modules.
The game is designed to address depressive symptoms in youth by helping them cope with negative thoughts and feelings, represented in the game as GNATs-Gloomy Negative Automatic Thoughts.
SPARX was originally designed and developed at the University of Auckland with the specific needs of certain underserved groups of youth in mind, including Māori rangatahi, the Indigenous young people of Aotearoa, New Zealand.
|
|
Active Comparator: "Play later" waitlist group
The sequence of SPARX play differed for the youth depending on whether they were in Group A ("play now" intervention group) or Group B ("play later" waitlist group).
Both groups completed the pre-intervention surveys at Time 1, the beginning of the study.
Group A youth then began to play SPARX for seven weeks while Group B waited.
During their wait time of seven weeks, Group B youth were not required to participate in any SPARX activities or meet with the community facilitator during their wait period, and they were provided with no additional SPARX-related information.
After seven weeks (Time 2), Group A youth completed post-intervention surveys, while Group B youth began their engagement with SPARX by first completing an additional set of pre-intervention surveys, immediately followed by seven weeks of SPARX play.
Once Group B youth completed their SPARX gameplay (Time 3), they completed post-intervention surveys.
|
SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts) is a psychoeducational serious game (an e-intervention that utilizes gaming for serious purposes) that teaches established cognitive behavioural therapy strategies and techniques across seven levels or modules.
The game is designed to address depressive symptoms in youth by helping them cope with negative thoughts and feelings, represented in the game as GNATs-Gloomy Negative Automatic Thoughts.
SPARX was originally designed and developed at the University of Auckland with the specific needs of certain underserved groups of youth in mind, including Māori rangatahi, the Indigenous young people of Aotearoa, New Zealand.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
"Centre for Epidemiologic Depression Scale - Revised"
Time Frame: Pre-gameplay (T=0)
|
20-item, self-report scale that aims to measure current depressive symptomatology
|
Pre-gameplay (T=0)
|
|
"Centre for Epidemiologic Depression Scale - Revised"
Time Frame: Post-gameplay (T=7 weeks)
|
20-item, self-report scale that aims to measure current depressive symptomatology
|
Post-gameplay (T=7 weeks)
|
|
"Hopelessness Scale for Children"
Time Frame: Pre-gameplay (T=0)
|
17 true-false items, which describe negative future expectations and negative present attitudes
|
Pre-gameplay (T=0)
|
|
"Hopelessness Scale for Children"
Time Frame: Post-gameplay (T=7 weeks)
|
17 true-false items, which describe negative future expectations and negative present attitudes
|
Post-gameplay (T=7 weeks)
|
|
"Cognitive Emotion Regulation Questionnaire - Short"
Time Frame: Pre-gameplay (T=0)
|
18-item measure used with adolescents composed of nine coping styles, which are each coded as separate subscales of emotion regulation
|
Pre-gameplay (T=0)
|
|
"Cognitive Emotion Regulation Questionnaire - Short"
Time Frame: Post-gameplay (T=7 weeks)
|
18-item measure used with adolescents composed of nine coping styles, which are each coded as separate subscales of emotion regulation
|
Post-gameplay (T=7 weeks)
|
|
"Child and Youth Resilience Measure - Short"
Time Frame: Pre-gameplay (T=0)
|
12-item self-report measure that includes three dimensions (Individual, Relational, and Contextual) that reflect the major categories of resilience
|
Pre-gameplay (T=0)
|
|
"Child and Youth Resilience Measure - Short"
Time Frame: Post-gameplay (T=7 weeks)
|
12-item self-report measure that includes three dimensions (Individual, Relational, and Contextual) that reflect the major categories of resilience
|
Post-gameplay (T=7 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yvonne Bohr, PhD, York University
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02 004 15N-M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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