JoyPop Mobile Mental Health App With Youth

Not Applicable

Recruiting

• Conditions: Emotion Regulation; Anxiety; Depression; Stress
• Interventions: Behavioral: Usual Practice + JoyPop

• Registration Number: NCT06239519
• Lead Sponsor: Lakehead University

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-01-25
• Study Start: 2024-02-01
• Study First Posted: 2024-02-02
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Practice + JoyPop	Usual Practice + JoyPop	Participants will be monitored through the existing wait-list practices, and will receive access to the JoyPop app for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in emotion regulation (impulse)	Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	Emotion regulation (impulse) 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)	Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	Emotion regulation (goals) 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 (strategies)	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 (awareness)	Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	Emotion regulation (awareness) 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 (non-acceptance)	Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	Emotion regulation (non-acceptance) 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 (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 (clarity)	Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	Emotion regulation (clarity) 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

Name	Time	Method
Change in emotional problems	Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	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 in anxious symptoms	Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	Anxious 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 anxious symptoms.
Change in conduct problems	Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	Conduct 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 in hyperactivity	Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	Hyperactivity 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 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)	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.
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)	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	Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	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 stress	Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	Stress 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 stress symptoms.
Change in overall difficulties	Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	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 in peer problems	Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	Peer 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 in prosocial behaviour	Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)	Prosocial behaviour will be assessed with the Prosocial subscale from the Strengths and Difficulties Questionnaire. Total scores range from 0 to 10 with lower scores indicating worse prosocial behaviour.

Trial Locations

Locations (1)

Lakehead University; 🇨🇦 Thunder Bay, Ontario, Canada