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JoyPop Mobile Mental Health App With Indigenous Transitional-Aged Youth

Primary Purpose

Emotion Regulation, Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Usual Practice + JoyPop
Sponsored by
Lakehead University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotion Regulation focused on measuring eHealth, mobile health, smartphone, emotion regulation, Indigenous, First Nations, mental health, youth, transitional-aged youth, waitlist

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lakehead UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Usual Practice + JoyPop

Usual Practice

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Change in emotion regulation (non-acceptance)
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)
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)
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)
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)
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 Outcome Measures

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.
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.
Change in anxious symptoms
Depressive 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 depressive symptoms.
Change in stress
Depressive symptoms 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 depressive symptoms.
Change is 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.
Change is 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.
Change is conduct problems
Emotional 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.
Change is hyperactivity
Emotional problems 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.
Change is peer problems
Emotional 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.
Change is prosocial behaviour
Emotional problems will be assessed with the Prosocial subscale from the Strengths and Difficulties Questionnaire. Total scores range from 0 to 10 with higher scores indicating worse prosocial behaviour.
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.

Full Information

First Posted
August 3, 2023
Last Updated
August 15, 2023
Sponsor
Lakehead University
Collaborators
Dilico Anishinabek Family Care
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1. Study Identification

Unique Protocol Identification Number
NCT05991154
Brief Title
JoyPop Mobile Mental Health App With Indigenous Transitional-Aged Youth
Official Title
Increasing Access to Mental Health Support for 18-25 Year Old Indigenous Youth With the JoyPop Mobile Mental Health App: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lakehead University
Collaborators
Dilico Anishinabek Family Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotion Regulation, Depression, Anxiety, Stress
Keywords
eHealth, mobile health, smartphone, emotion regulation, Indigenous, First Nations, mental health, youth, transitional-aged youth, waitlist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Masking Description
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).
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Practice + JoyPop
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Practice
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Practice + JoyPop
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in emotion regulation (overall)
Description
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)
Title
Change in emotion regulation (strategies)
Description
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.
Time Frame
Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change in emotion regulation (non-acceptance)
Description
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.
Time Frame
Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change in emotion regulation (impulse)
Description
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.
Time Frame
Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change in emotion regulation (goals)
Description
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.
Time Frame
Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change in emotion regulation (awareness)
Description
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.
Time Frame
Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change in emotion regulation (clarity)
Description
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.
Time Frame
Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Secondary Outcome Measure Information:
Title
Change in psychological distress
Description
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.
Time Frame
Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change in depressive symptoms
Description
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.
Time Frame
Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change in anxious symptoms
Description
Depressive 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 depressive symptoms.
Time Frame
Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change in stress
Description
Depressive symptoms 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 depressive symptoms.
Time Frame
Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change is overall difficulties
Description
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.
Time Frame
Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change is emotional problems
Description
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.
Time Frame
Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change is conduct problems
Description
Emotional 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.
Time Frame
Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change is hyperactivity
Description
Emotional problems 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.
Time Frame
Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change is peer problems
Description
Emotional 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.
Time Frame
Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change is prosocial behaviour
Description
Emotional problems will be assessed with the Prosocial subscale from the Strengths and Difficulties Questionnaire. Total scores range from 0 to 10 with higher scores indicating worse prosocial behaviour.
Time Frame
Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Change in treatment readiness
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
App quality (overall)
Description
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.
Time Frame
User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
Title
App quality (engagement)
Description
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).
Time Frame
User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
Title
App quality (functionality)
Description
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).
Time Frame
User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
Title
App quality (aesthetics)
Description
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).
Time Frame
User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
Title
App quality (information)
Description
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).
Time Frame
User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
Title
App quality (subjective)
Description
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).
Time Frame
User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
Title
App quality (perceived impact)
Description
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).
Time Frame
User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
Title
Service utilization
Description
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.
Time Frame
Service utilization measure will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Title
Minimal Clinically Important Difference (MCID)
Description
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.
Time Frame
GRC will be administered to the intervention group after 2 weeks (mid) and 4 weeks (post)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aislin R Mushquash, Ph.D.
Phone
807-343-8010
Ext
8771
Email
aislin.mushquash@lakeheadu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aislin R Mushquash, Ph.D.
Organizational Affiliation
Lakehead University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lakehead University
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B5E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aislin R Mushquash, Ph.D.
First Name & Middle Initial & Last Name & Degree
Elaine Toombs, PhD
First Name & Middle Initial & Last Name & Degree
Fred Schmidt, PhD
First Name & Middle Initial & Last Name & Degree
Janine Olthuis, PhD
First Name & Middle Initial & Last Name & Degree
Sherry Stewart, PhD
First Name & Middle Initial & Last Name & Degree
Amanda Newton, PhD
First Name & Middle Initial & Last Name & Degree
Arto Ohinmaa, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
In accordance with the Ownership, Control, Access, and Possession (OCAPTM) standards set by the First Nations Information Governance Centre, data obtained from Indigenous youth will be owned, controlled, and managed through the partner organization Dilico Anishinabek Family Care.

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JoyPop Mobile Mental Health App With Indigenous Transitional-Aged Youth

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