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Clinical Trials/NCT05991154
NCT05991154
Recruiting
N/A

Increasing Access to Mental Health Support for 18-25 Year Old Indigenous Youth With the JoyPop Mobile Mental Health App: Randomized Controlled Trial

Lakehead University1 site in 1 country110 target enrollmentAugust 11, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Emotion Regulation
Sponsor
Lakehead University
Enrollment
110
Locations
1
Primary Endpoint
Change in emotion regulation (overall)
Status
Recruiting
Last Updated
7 months ago

Overview

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. 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.

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. 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.

Registry
clinicaltrials.gov
Start Date
August 11, 2023
End Date
December 31, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Indigenous transitional-aged youth must be on the wait-list for mental health services at Dilico Anishinabek Family Care and be between 18-25 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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in emotion regulation (overall)

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.

Change in emotion regulation (strategies)

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.

Change in emotion regulation (non-acceptance)

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.

Change in emotion regulation (impulse)

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.

Change in emotion regulation (goals)

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.

Change in emotion regulation (awareness)

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.

Change in emotion regulation (clarity)

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.

Secondary Outcomes

  • Change in psychological distress(Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
  • Change in 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(Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
  • Change in stress(Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
  • Change is overall difficulties(Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
  • Change is emotional problems(Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
  • Change is conduct problems(Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
  • Change is hyperactivity(Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
  • Change is peer problems(Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
  • Change is 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 subscale of the Motivation for Youth's Treatment Scale will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))

Study Sites (1)

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