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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05702086
Other study ID # 02 004 15N-M
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 8, 2014
Est. completion date April 22, 2015

Study information

Verified date January 2023
Source York University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date April 22, 2015
Est. primary completion date April 22, 2015
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts)
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 Maori rangatahi, the Indigenous young people of Aotearoa, New Zealand.

Locations

Country Name City State
Canada York University Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
York University Government of Nunavut, Qaujigiartiit Health Research Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary "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)
Primary "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)
Primary "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)
Primary "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)
Primary "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)
Primary "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)
Primary "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)
Primary "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)
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