Depressive SymptomsNCT05702086
Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression
A study testing SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts) in people with Depressive Symptoms and Emotion Regulation, run by York University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depressive Symptoms, Emotion Regulation
- What is being tested?
- SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 8 Sep 2014to 22 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Depressive Symptoms, Emotion Regulation
- Being tested
- SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts)
- Keywords
- hopelessness, catastrophizing, rumination, resilience
- Medical subject headings
- Depression, Emotional Regulation, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: 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. Receives: Other: SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts) |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Post-gameplay (T=7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start8 Sep 2014
- Primary completion22 Apr 2015
- Study completion22 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Nunavut, Qaujigiartiit Health Research Centre
- Responsible party
- Principal investigator, Yvonne Bohr, York University
- Investigators
- Yvonne Bohr, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702086
- Sponsor's protocol ID
- 02 004 15N-M
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36892940
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Utility of a Psychoeducational Serious Game (SPARX) in Protecting Inuit Youth From Depression: A Pilot Study
- ClinicalTrials.gov ID
- NCT05702086
- Acronym / sponsor ID
- 02 004 15N-M
- Conditions
- Depressive Symptoms, Emotion Regulation
- Keywords
- hopelessness, catastrophizing, rumination, resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Government of Nunavut, Qaujigiartiit Health Research Centre
- Study start
- 8 Sep 2014 (actual)
- Primary completion
- 22 Apr 2015 (actual)
- Study completion
- 22 Apr 2015 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Play now" intervention group | Experimental | Other: SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts)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. |
| "Play later" waitlist group | Active comparator | Other: SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts)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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- one or more of the following:
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 Māori rangatahi, the Indigenous young people of Aotearoa, New Zealand. | Other | "Play later" waitlist group, "Play now" intervention group |
Primary outcome
"Centre for Epidemiologic Depression Scale - Revised"
Time frame: Pre-gameplay (T=0)
20-item, self-report scale that aims to measure current depressive symptomatology; total scores range 0-60 with higher score representing worse depression
"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; total scores range 0-60 with higher score representing worse depression
"Hopelessness Scale for Children"
Time frame: Pre-gameplay (T=0)
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
"Hopelessness Scale for Children"
Time frame: Post-gameplay (T=7 weeks)
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
"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; 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
"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; 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
"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; total scores range from 12-36 (no; sometimes; yes for 12 items at 1, 2, 3, points respectively); higher scores indicate higher resilience
"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; total scores range from 12-36 (no; sometimes; yes for 12 items at 1, 2, 3, points respectively); higher scores indicate higher resilience
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 36892940Bohr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Bohr, PhD principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARX (Smart, Positive, Active, Realistic, X-Factor thoughts) in people with Depressive Symptoms and Emotion Regulation, run by York University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Centre for Epidemiologic Depression Scale - Revised" (time frame: Pre-gameplay (T=0)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.