Clinical trial NCT05898516: JoyPop Mobile Mental Health App With Indigenous Youth
Official title: Increasing Access to Mental Health Support for 12-17 Year Old Indigenous 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
Keywords: eHealth
mobile health
smartphone
emotion regulation
Indigenous
First Nations
mental health
youth
adolescents
waitlist
Lead sponsor: Lakehead University
Sponsor class: OTHER
Collaborators: name: Dilico Anishinabek Family Care
First posted: 2023-06-12
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: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Indigenous youth must be on the wait-list for mental health services at Dilico Anishinabek Family Care 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: 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 is overall difficulties
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change is emotional problems
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change is conduct problems
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change is hyperactivity
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change is peer problems
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change is 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:
affiliation: Lakehead University
name: Aislin R Mushquash, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: