NCT05702086

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

September 8, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2015

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 10, 2023

Last Update Submit

January 27, 2023

Conditions

Keywords

hopelessnesscatastrophizingruminationresilience

Outcome Measures

Primary Outcomes (8)

  • "Centre for Epidemiologic Depression Scale - Revised"

    20-item, self-report scale that aims to measure current depressive symptomatology; total scores range 0-60 with higher score representing worse depression

    Pre-gameplay (T=0)

  • "Centre for Epidemiologic Depression Scale - Revised"

    20-item, self-report scale that aims to measure current depressive symptomatology; total scores range 0-60 with higher score representing worse depression

    Post-gameplay (T=7 weeks)

  • "Hopelessness Scale for Children"

    17 true-false items, which describe negative future expectations and negative present attitudes; scores range from 0-17 with higher score representing greater hopelessness for the future

    Pre-gameplay (T=0)

  • "Hopelessness Scale for Children"

    17 true-false items, which describe negative future expectations and negative present attitudes; scores range from 0-17 with higher score representing greater hopelessness for the future

    Post-gameplay (T=7 weeks)

  • "Cognitive Emotion Regulation Questionnaire - Short"

    18-item measure used with adolescents composed of nine coping styles, which are each coded as separate subscales of emotion regulation; items are scored on a Likert scale (1-5) with higher values corresponding to greater use of that cognitive strategy. Some strategies are positive, others negative

    Pre-gameplay (T=0)

  • "Cognitive Emotion Regulation Questionnaire - Short"

    18-item measure used with adolescents composed of nine coping styles, which are each coded as separate subscales of emotion regulation; items are scored on a Likert scale (1-5) with higher values corresponding to greater use of that cognitive strategy. Some strategies are positive, others negative

    Post-gameplay (T=7 weeks)

  • "Child and Youth Resilience Measure - Short"

    12-item self-report measure that includes three dimensions (Individual, Relational, and Contextual) that reflect the major categories of resilience; total scores range from 12-36 (no; sometimes; yes for 12 items at 1, 2, 3, points respectively); higher scores indicate higher resilience

    Pre-gameplay (T=0)

  • "Child and Youth Resilience Measure - Short"

    12-item self-report measure that includes three dimensions (Individual, Relational, and Contextual) that reflect the major categories of resilience; total scores range from 12-36 (no; sometimes; yes for 12 items at 1, 2, 3, points respectively); higher scores indicate higher resilience

    Post-gameplay (T=7 weeks)

Study Arms (2)

"Play now" intervention group

EXPERIMENTAL

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.

Other: SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts)

"Play later" waitlist group

ACTIVE COMPARATOR

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.

Other: SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts)

Interventions

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.

"Play later" waitlist group"Play now" intervention group

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • one or more of the following:
  • low mood
  • negative affect
  • depressive presentations
  • significant levels of stress and:
  • sufficient English language comprehension to use and understand SPARX

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

Related Publications (1)

  • Bohr Y, Litwin L, Hankey JR, McCague H, Singoorie C, Lucassen MFG, Shepherd M, Barnhardt J. Evaluating the Utility of a Psychoeducational Serious Game (SPARX) in Protecting Inuit Youth From Depression: Pilot Randomized Controlled Trial. JMIR Serious Games. 2023 Mar 9;11:e38493. doi: 10.2196/38493.

MeSH Terms

Conditions

DepressionEmotional RegulationRumination Syndrome

Interventions

Gene ExpressionExercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-ControlSocial BehaviorGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Genetic PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yvonne Bohr, PhD

    York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 27, 2023

Study Start

September 8, 2014

Primary Completion

April 22, 2015

Study Completion

April 22, 2015

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations