JoyPop Mobile Mental Health App With Indigenous Youth

NCT ID: NCT05898516

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-26

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Emotion Regulation Depression Anxiety Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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).

Study Groups

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Usual Practice + JoyPop

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.

Group Type EXPERIMENTAL

Usual Practice + JoyPop

Intervention Type 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.

Usual Practice

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Usual Practice + JoyPop

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dilico Anishinabek Family Care

UNKNOWN

Sponsor Role collaborator

Lakehead University

OTHER

Sponsor Role lead

Responsible Party

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Aislin Mushquash

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aislin R Mushquash, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Lakehead University

Locations

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Lakehead University

Thunder Bay, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Aislin R Mushquash, Ph.D.

Role: CONTACT

807-343-8010 ext. 8771

Facility Contacts

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Aislin R Mushquash, Ph.D.

Role: primary

References

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Mushquash AR, Neufeld T, Malik I, Toombs E, Olthuis JV, Schmidt F, Dunning C, Stasiuk K, Bobinski T, Ohinmaa A, Newton A, Stewart SH. Increasing access to mental health supports for 12-17-year-old Indigenous youth with the JoyPop mobile mental health app: study protocol for a randomized controlled trial. Trials. 2024 Apr 4;25(1):234. doi: 10.1186/s13063-024-08076-y.

Reference Type DERIVED
PMID: 38575945 (View on PubMed)

Other Identifiers

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100157

Identifier Type: -

Identifier Source: org_study_id

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