NCT05898516

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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 6, 2025

Status Verified

October 1, 2024

Enrollment Period

2.5 years

First QC Date

June 1, 2023

Last Update Submit

March 3, 2025

Conditions

Emotion RegulationDepressionAnxietyStress

Keywords

eHealthmobile healthsmartphoneemotion regulationIndigenousFirst Nationsmental healthyouthadolescentswaitlist

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)

  • +6 more secondary outcomes

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)

  • +6 more other outcomes

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 + JoyPopBEHAVIORAL

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

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lakehead University

Thunder Bay, Ontario, P7B5E1, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38575945DERIVED

MeSH Terms

Conditions

Emotional RegulationDepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorBehavioral SymptomsMental DisordersPersonal Satisfaction

Study Officials

  • Aislin R Mushquash, Ph.D.

    Lakehead University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aislin R Mushquash, Ph.D.

CONTACT

807-343-8010aislin.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
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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 12, 2023

Study Start

May 26, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 6, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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.

Locations

CA(1)