Clinical trial NCT06239519: JoyPop Mobile Mental Health App With Youth
Official title: Increasing Access to Mental Health Support for 12-17 Year Old Youth With the JoyPop Mobile Mental Health App: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Depression
Anxiety
Stress
Lead sponsor: Lakehead University
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 110
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Youth must be on the wait-list for mental health services at St. Joseph's Care Group or Thunder Bay Counselling Centre and be between 12-17 years old.
* Eligible youth will also need to be available to attend a virtual or in-person orientation session.
* In order to download the JoyPop app, participants will need access to an iOS device (e.g., iPhone, iPad). Refurbished iPhones containing just the JoyPop app will be provided to participants to use for the duration of the trial if they do not have access to their own.

Primary outcomes:
measure: Change in emotion regulation (overall)
timeFrame: Time Frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in emotion regulation (strategies)
timeFrame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in emotion regulation (non-acceptance)
timeFrame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in emotion regulation (impulse)
timeFrame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in emotion regulation (goals)
timeFrame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in emotion regulation (awareness)
timeFrame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in emotion regulation (clarity)
timeFrame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Secondary outcomes:
measure: Change in psychological distress
timeFrame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in depressive symptoms
timeFrame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in anxious symptoms
timeFrame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in stress
timeFrame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in overall difficulties
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in emotional problems
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in conduct problems
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in hyperactivity
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in peer problems
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in prosocial behaviour
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in treatment readiness
timeFrame: 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)
Other outcomes:
measure: App quality (overall)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (engagement)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (functionality)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (aesthetics)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (information)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (subjective)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (perceived impact)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: Service utilization
timeFrame: Service utilization measure will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Minimal Clinically Important Difference (MCID)
timeFrame: GRC will be administered to the intervention group after 2 weeks (mid) and 4 weeks (post)
Locations:
city: Thunder Bay
country: Canada
facility: Lakehead University
state: Ontario
Study officials:
References: