An interventional study of Usual Practice + JoyPop in Emotion Regulation, Depression and Anxiety, sponsored by Lakehead University. Recruiting at 1 site in Canada. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Lakehead University · Not applicable, Interventional, and Treatment
Indigenous youth in Northwestern Ontario who need mental health supports experience longer waits than non-Indigenous youth within the region and when compared to youth in other more urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, and increase risk for more serious outcomes. Novel, innovative approaches are urgently needed to provide support for Indigenous youth in Northwestern Ontario. In partnership with Dilico Anishinabek Family Care, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for Indigenous youth who are waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a key difficulty for youth presenting with mental health challenges. A two-arm randomized controlled trial (RCT) will be used to evaluate the effectiveness of the app compared to usual practice while Indigenous youth are waiting for mental health services.
Indigenous youth in Northwestern Ontario who need mental health supports experience longer waits than non-Indigenous youth within the region and when compared to youth in other more urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, increase risk for more serious outcomes like suicide, self-harm, and hospitalization, and negatively impact engagement in treatment once it is offered. Novel, innovative approaches are urgently needed to provide support for Indigenous youth in Northwestern Ontario.
In partnership with Dilico Anishinabek Family Care, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for Indigenous youth who are waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a key difficulty for youth presenting with mental health challenges. Despite the promise of mobile mental health apps, significant gaps exist between the growing number of apps available in the public domain and empirical demonstration of the beneficial impacts of apps for users. Of the apps that address emotion regulation, most have not been evaluated, are narrow in scope, or have only been evaluated among non-diverse adult populations. The JoyPop app includes a broader focus, and this research is unique given its focus on rigorously evaluating the JoyPop app as a tool for treatment-seeking, Indigenous youth in Northwestern Ontario.
Using a randomized controlled trial (RCT) design, the primary objective is to determine the effectiveness of the JoyPop app in improving emotion regulation among Indigenous youth (12-17) who are waiting for mental health services as compared to usual practice (UP; monitoring those on the wait-list). The secondary objectives are to: (1) Assess change in mental health difficulties and treatment readiness between youth in each condition to better understand the app's broader impact as a wait-list tool; (2) Conduct an economic analysis to determine whether receiving the app while waiting for mental health services reduces other health service use and associated costs; (3) Define the Minimal Clinically Important Difference (MCID) for the primary outcome measure; and (4) Assess youth perspective the quality of the JoyPop app.
545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.
This study's planned enrollment of 110 is above the median of 79 across 498 interventional studies indexed under Emotional Regulation.
Browse Emotional Regulation studies →Lakehead University is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Participants will be monitored through the existing wait-list practices, which involve regular phone calls to check in and assess functioning, and will receive access to the JoyPop app for 4 weeks.
Behavioral: Usual Practice + JoyPop
Participants will be monitored through existing wait-list practices which involve regular phone calls to check in and assess functioning. After 4 weeks in the Usual Practice condition, participants will be offered access to the JoyPop app.
Participants will be asked to use the app at least twice daily but will otherwise not be provided with requirements related to feature or total usage.
Change in emotion regulation (overall)
Emotion regulation will be assessed with the Difficulties in Emotion Regulation Scale - Short Form. Total scores range from 18 to 90 with higher scores indicating greater difficulties in emotion regulation.
Time frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change in emotion regulation (strategies)
Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form strategies subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.
Time frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change in emotion regulation (non-acceptance)
Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form non-acceptance subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.
Time frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change in emotion regulation (impulse)
Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form impulse subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.
Time frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change in emotion regulation (goals)
Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form goals subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.
Time frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change in emotion regulation (awareness)
Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form awareness subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.
Time frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change in emotion regulation (clarity)
Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form clarity subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.
Time frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change in psychological distress
Psychological distress will be assessed with the total score for all items on the Depression Anxiety and Stress Scale 21. Total scores range from 0 to 63 with higher scores indicating greater psychological distress.
Time frame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change in depressive symptoms
Depressive symptoms will be assessed with the Depression subscale of the Depression Anxiety and Stress Scale 21. Total scores range from 0 to 21 with higher scores indicating greater depressive symptoms.
Time frame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change in anxious symptoms
Anxious symptoms will be assessed with the Anxiety subscale of the Depression Anxiety and Stress Scale 21. Total scores range from 0 to 21 with higher scores indicating greater anxious symptoms.
Time frame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change in stress
Stress will be assessed with the Stress subscale of the Depression Anxiety and Stress Scale 21. Total scores range from 0 to 21 with higher scores indicating greater stress.
Time frame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change is overall difficulties
Overall difficulties will be assessed with the total score from the Strengths and Difficulties Questionnaire (all subscales except prosocial). Total scores range from 0 to 40 with higher scores indicating worse difficulties.
Time frame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change is emotional problems
Emotional problems will be assessed with the Emotional Problems subscale from the Strengths and Difficulties Questionnaire. Total scores range from 0 to 10 with higher scores indicating worse emotional problems.
Time frame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change is conduct problems
Conduct problems will be assessed with the Conduct Problems subscale from the Strengths and Difficulties Questionnaire. Total scores range from 0 to 10 with higher scores indicating worse conduct problems.
Time frame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change is hyperactivity
Hyperactivity will be assessed with the Hyperactivity subscale from the Strengths and Difficulties Questionnaire. Total scores range from 0 to 10 with higher scores indicating worse hyperactivity.
Time frame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change is peer problems
Peer problems will be assessed with the Peer Problems subscale from the Strengths and Difficulties Questionnaire. Total scores range from 0 to 10 with higher scores indicating worse peer problems.
Time frame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change is prosocial behaviour
Prosocial behaviour will be assessed with the Prosocial subscale from the Strengths and Difficulties Questionnaire. Total scores range from 0 to 10 with higher scores indicating worse prosocial behaviours.
Time frame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Change in treatment readiness
Treatment readiness will be assessed with the Treatment Readiness subscale of the Motivation for Youth's Treatment Scale. Total scores range from 4 to 20 with higher scores indicating greater readiness.
Time frame: Treatment Readiness subscale of the Motivation for Youth's Treatment Scale will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
App quality (overall)
App quality (overall) will be assessed with the User Version of the Mobile Application Rating Scale. Total scores range from 1 to 5 with higher scores indicating greater quality.
Time frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
App quality (engagement)
App quality (engagement) will be assessed with the Engagement subscale of the User Version of the Mobile Application Rating Scale. Total scores range from 1 to 5 with higher scores indicating greater quality (engagement).
Time frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
App quality (functionality)
App quality (functionality) will be assessed with the Functionality subscale of the User Version of the Mobile Application Rating Scale. Total scores range from 1 to 5 with higher scores indicating greater quality (functionality).
Time frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
App quality (aesthetics)
App quality (aesthetics) will be assessed with the Aesthetics subscale of the User Version of the Mobile Application Rating Scale. Total scores range from 1 to 5 with higher scores indicating greater quality (aesthetics).
Time frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
App quality (information)
App quality (information) will be assessed with the Information subscale of the User Version of the Mobile Application Rating Scale. Total scores range from 1 to 5 with higher scores indicating greater quality (information).
Time frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
App quality (subjective)
App quality (subjective) will be assessed with the App Subjective Quality items of the User Version of the Mobile Application Rating Scale. Items will be assessed individually and as a total score (range from 1 to 5) with higher scores indicating greater quality (subjective).
Time frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
App quality (perceived impact)
App quality (perceived impact) will be assessed with the Perceived Impact subscale of the User Version of the Mobile Application Rating Scale. Items will be assessed individually and as a total score (range from 1 to 5) with higher scores indicating greater quality (perceived impact).
Time frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
Service utilization
Service utilization will be assessed with 5 items asking about frequency of healthcare services accessed over the prior 2 weeks. Response options are open-ended and will be analyzed individually and as a total score across service types.
Time frame: Service utilization measure will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Minimal Clinically Important Difference (MCID)
On the Global Rating of Change (GRC), the smallest change in emotion regulation that participants identify as important after completing the trial will be used to calculate the MCID. The GRC is an 11-point Likert scale (ranging from -5 to +5; -5 very much worse, 0 unchanged, +5 very much better) used to indicate the degree to which emotion regulation changed for the better, for the worse, or no change after receiving the intervention.
Time frame: GRC will be administered to the intervention group after 2 weeks (mid) and 4 weeks (post)
Plan to share: No — In accordance with the Ownership, Control, Access, and Possession (OCAPTM) standards set by the First Nations Information Governance Centre, data obtained from Indigenous youth will be owned, controlled, and managed through the partner organization Dilico Anishinabek Family Care.
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Dec 2025, 31 months after the start.
Of 390 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 31 months is above that.
Counting every sponsor, half of 396 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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Lakehead University