Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Youth in Canada are in need of novel, innovative approaches to support their mental health and wellbeing. Within this age group, research suggests rates of several mental health difficulties and related hospitalizations have increased over recent decades. These challenges are exacerbated in rural communities, such as in Northwestern Ontario, where youth access mental health services less frequently and face longer wait times than those in more urban areas. Such limited access and extended waits can exacerbate symptoms, prolong distress, and increase the risk for adverse outcomes. In partnership with St. Joseph Care Group and Thunder Bay Counselling Centre, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for youth waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a fundamental difficulty for youth presenting with mental health challenges and an ability still undergoing maturation during this developmental period. A two-arm randomized controlled trial (RCT) will be used to evaluate the effectiveness of the app compared to usual practice while youth aged 12-17 are waiting for mental health services.
Mental health services are less available and accessible in rural and northern communities than in urban areas. These issues are concerning as extended time on wait lists can exacerbate symptoms, prolong symptoms, prolong distress, and increase the risk for suicide, self-harm, and the need for hospitalization. Moreover, delayed access to mental health services negatively impacts treatment engagement, with non-attendance, decreased motivation, and reduced satisfaction with services frequently reported following prolonged wait times. A particularly vulnerable group in this context is adolescent youth, for whom research suggests mental health symptoms such as anxiety and depression and related hospital visits have increased in recent decades. Given the imminent need for and reduced access to accessible mental health services for youth in Northwestern Ontario, innovative solutions are needed. In partnership with St. Joseph Care Group and Thunder Bay Counselling Centre, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for youth who are waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - an ability still undergoing development during adolescence and which can present as a key difficulty for youth with mental health challenges. Mobile mental health applications have the potential to increase accessible mental health support for youth in Northwestern Ontario. Despite this promise of mobile mental health apps, significant gaps exist between the growing number of apps available in the public domain and empirical evidence of the beneficial impacts of apps for users. In particular, most apps that focus on emotion regulation have not been evaluated, are narrow in scope, or have only been evaluated among 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 youth aged 12-17 in Northwestern Ontario, a population that has previously expressed interest in using the JoyPop in a pilot study.
Using a randomized controlled trial (RCT) design, the primary objective is to determine the effectiveness of the JoyPop app in improving emotion regulation among 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 perspectives on the quality of the JoyPop app.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Practice + JoyPop | Experimental | Participants will be monitored through the existing wait-list practices, and will receive access to the JoyPop app for 4 weeks. |
|
| Usual Practice | No Intervention | Participants will be monitored through existing wait-list practices. After 4 weeks in the Usual Practice condition, participants will be offered access to the JoyPop app. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Practice + JoyPop | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 (non-acceptance) 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. | 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 (impulse) 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. | 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 (goals) 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post) |
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aislin R Mushquash, Ph.D. | Contact | 807-343-8010 | 8771 | aislin.mushquash@lakeheadu.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakehead University | Recruiting | Thunder Bay | Ontario | P7B5E1 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000080103 | Emotional Regulation |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
A pragmatic, parallel arm randomized controlled superiority trial will be used. Participants will be randomly allocated in a 1:1 ratio to the control (usual practice; UP) or intervention (UP + JoyPop) condition. Stratified block randomization (block size of 10) will be used to randomly assign participants to each condition.
Not provided
Not provided
Given the nature of this trial, it will not be possible to blind participants to their allocation. As measures are self report, blinding of outcome measures is also not possible. Protect against bias will occur by blinding investigators to condition (i.e., only staff directly managing participants will be unblinded).
| 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 (awareness) 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. | 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 (clarity) 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. | Difficulties in Emotion Regulation Scale - Short Form 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. | 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. | 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 symptoms. | Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post) |
| Change in 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. | Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post) |
| Change in 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. | Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post) |
| Change in 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. | Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post) |
| Change in 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. | Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post) |
| Change in 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. | Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post) |
| Change in 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 lower scores indicating worse prosocial behaviour. | 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. | 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 (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). |
| 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). | 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). | 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). | 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 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). | 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. Total scores range from 1 to 5 with higher scores indicating greater quality (perceived impact). | 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. | 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. | GRC will be administered to the intervention group after 2 weeks (mid) and 4 weeks (post) |
| D001523 |
| Mental Disorders |