JoyPop Mobile Mental Health App With Indigenous Transitional-Aged Youth

NCT05991154 | Recruiting

• 1 other identifier: 100157(1)
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotion Regulation; Depression; Anxiety; Stress

Keywords

eHealth; mobile health; smartphone; emotion regulation; Indigenous; First Nations; mental health; youth; transitional-aged youth; waitlist

Outcome Measures

Primary Outcomes (7)

• 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.

  Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)

• 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.

  Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)

• 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.

  Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)

• 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.

  Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)

• 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.

  Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)

• 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.

  Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)

• 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.

  Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)

Secondary Outcomes (11)

• 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)

Other Outcomes (9)

• App quality (overall)

  User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)

• App quality (engagement)

  User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)

• App quality (functionality)

  User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)

Study Arms (2)

Usual Practice + JoyPop

EXPERIMENTAL

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.

Behavioral: Usual Practice + JoyPop

Usual Practice

NO INTERVENTION

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.

Interventions

Usual Practice + JoyPop 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 + JoyPop

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Lakehead University: lead
• Dilico Anishinabek Family Care: collaborator

Study Sites (1)

Lakehead University

Thunder Bay, Ontario, P7B5E1, Canada

RECRUITING

Related Publications (1)

• MacIsaac A, Neufeld T, Malik I, Toombs E, Olthuis JV, Schmidt F, Dunning C, Stasiuk K, Bobinski T, Ohinmaa A, Stewart SH, Newton AS, Mushquash AR. Increasing Access to Mental Health Supports for 18- to 25-Year-Old Indigenous Youth With the JoyPop Mobile Mental Health App: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 30;14:e64745. doi: 10.2196/64745.

  PMID: 39883939 DERIVED

MeSH Terms

Conditions

Emotional Regulation; Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Behavioral Symptoms; Mental Disorders; Personal Satisfaction

Study Officials

• Aislin R Mushquash, Ph.D.

  Lakehead University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aislin R Mushquash, Ph.D.

CONTACT

807-343-8010; aislin.mushquash@lakeheadu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 11, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)