NCT Number: NCT05991154
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. Transitional aged youth (i.e., those in their mid-late teens to early twenties) are a particularly vulnerable group. 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 transitional-aged 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 transitional-aged youth are waiting for mental health services.
Interested in participating?
Request Info18 year–25 year
All sexes
Interventional
Not applicable
Thunder Bay, Ontario, P7B5E1, Canada
Location status: Recruiting
Aislin R Mushquash, Ph.D.
CONTACT
Amanda Newton, PhD
SUB_INVESTIGATOR
Arto Ohinmaa, PhD
SUB_INVESTIGATOR
Elaine Toombs, PhD
SUB_INVESTIGATOR
Fred Schmidt, PhD
SUB_INVESTIGATOR
Janine Olthuis, PhD
SUB_INVESTIGATOR
Sherry Stewart, PhD
SUB_INVESTIGATOR
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. Transitional aged youth (i.e., those in their mid-late teens to early twenties) are a particularly vulnerable group as they are navigating many developmental challenges (e.g., identity, relationships, schooling, housing) with the loss of supports and structures that may have been in place during childhood and adolescence. Transitional aged youth in underserviced areas such as Northwestern Ontario have increased need for and decreased access to mental health treatment, especially those in rural and remote areas. 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 transitional-aged 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 transitional-aged 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 transitional-aged youth (18-25) 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Time frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
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)
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)
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)
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)
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)
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)
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: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
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)
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)
Depressive 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 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)
Depressive symptoms 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 depressive symptoms.
Time frame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
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)
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)
Emotional 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)
Emotional problems 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)
Emotional 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)
Emotional problems 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 behaviour.
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)
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: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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) 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) 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) 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) 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) will be assessed with the Subjective subscale of the User Version of the Mobile Application Rating Scale. Total scores 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) will be assessed with the Perceived Impact subscale of the User Version of the Mobile Application Rating Scale. Total scores range from 1 to 5 with higher scores indicating greater quality (perceived impact).
Time frame: Service utilization measure will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
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: GRC will be administered to the intervention group after 2 weeks (mid) and 4 weeks (post)
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.
Contact information is provided by the study sponsor or research team.
Lakehead University
Other
Increasing Access to Mental Health Support for 18-25 Year Old Indigenous Youth With the JoyPop Mobile Mental Health App: Randomized Controlled Trial
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