Qoyangnuptu: Qoyangnuptu Intervention (QI) App

NCT06254924 | Recruiting

• 1 other identifier: 2125143
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the impacts of using a mobile health app, the Qoyangnuptu Intervention App (QI App) a Southwestern Tribal Community. The main questions it aims to answer are: In American Indian/Alaska Native communities with unique cultural characteristics, how should a youth-focused sociotechnical behavioral health intervention be designed to encourage sustained engagement and positively impact indicators of behavioral health?; How can interactive technical interventions be designed to best support sustained community engagement in a challenged network environment? Participants will:

• Receive daily guidance and encouragement to use the app from an anonymous, trained peer mentor
• Be able to ask their peer mentors questions in a monitored one-on-one chat in the QI app or in a monitored group chat in the QI app
• Log their mood and stress level on the app once per day
• Practice mindfulness skills as directed in the QI app, including guided breathing, meditation, drawing, coloring, and walking
• Practice Hopi cultural activities like running using the QI app to help track progress towards team mileage goals

Conditions

Mental Health Wellness 1

Keywords

American Indian / Alaska Native; mHealth

Outcome Measures

Primary Outcomes (1)

• To measure the acceptability of the QI App.

  Through qualitative interviews, the investigators will determine the acceptability of the QI App. 12 participants will be interviewed after they have used the app for 6 weeks.

  Baseline, 6 weeks after starting the app, 12 weeks after starting the app

Secondary Outcomes (8)

• Impact of app usage on attitudes towards seeking professional mental health assistance.

  Baseline, 6 weeks after starting the app, 12 weeks after starting the app

• Impact of app usage on measures of depression.

  Baseline, 6 weeks after starting the app, 12 weeks after starting the app

• Impact of app usage on measures of stress.

  Baseline, 6 weeks after starting the app, 12 weeks after starting the app

• Impact of app usage on measures of mindfulness.

  Baseline, 6 weeks after starting the app, 12 weeks after starting the app

• Impact of app usage on measures of quiet ego.

  Baseline, 6 weeks after starting the app, 12 weeks after starting the app

Study Arms (2)

QI App Users

EXPERIMENTAL

Participants will be asked to use the QI App once per day for 5-10 minutes per day for 6 weeks.

Behavioral: QI App Users

Parents/Guardians of QI App Users

EXPERIMENTAL

Parents/guardians of QI App users will be aware that their child is using the QI App once per day for 5-10 minutes per day for 6 weeks.

Behavioral: Parents/Guardians of QI App Users

Interventions

QI App Users BEHAVIORAL

QI App users will be asked to complete a daily, 2-question mood and stress survey. They will be encouraged to use the QI App to practice mindfulness skills including meditation, drawing, coloring, breathing, and walking. They will be encouraged to use the QI App to help them participate in asynchronous group running activities.

QI App Users

Parents/Guardians of QI App Users BEHAVIORAL

Parents/Guardians of QI App users will be informed that their child is using the QI App for a 6-week period.

Parents/Guardians of QI App Users

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Belongs to Southwestern Tribal community
• Has a smartphone capable of running the QI App
• Is able to access the Internet with smartphone at least once per day

You may not qualify if:

• Younger than 14 or older than 25
• Does not belong to Southwestern Tribal Community
• Does not have a smartphone capable of running the QI App
• Is not able to access the Internet with smartphone at least once per day

Sponsors & Collaborators

• Northern Arizona University: lead

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

RECRUITING

Related Publications (8)

• Vigil-Hayes M, Collier AF, Hagemann S, Castillo G, Mikkelson K, Dingman J, Munoz A, Luther J, McLaughlin A. Integrating Cultural Relevance into a Behavioral mHealth Intervention for Native American Youth. Proc ACM Hum Comput Interact. 2021 Apr;5(CSCW1):165. doi: 10.1145/3449239.

  PMID: 34676359 BACKGROUND

• Vigil-Hayes M, Futterman Collier A, Castillo G, Blackhorse D, Awbery N, Abrahim JP. Designing a Mobile Game That Develops Emotional Resiliency in Indian Country. Ext Abstr Hum Factors Computing Syst. 2019 May;2019:LBW2122. doi: 10.1145/3290607.3312790.

  PMID: 32455346 BACKGROUND

• Picco L, Abdin E, Chong SA, Pang S, Shafie S, Chua BY, Vaingankar JA, Ong LP, Tay J, Subramaniam M. Attitudes Toward Seeking Professional Psychological Help: Factor Structure and Socio-Demographic Predictors. Front Psychol. 2016 Apr 25;7:547. doi: 10.3389/fpsyg.2016.00547. eCollection 2016.

  PMID: 27199794 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.

  PMID: 18504506 BACKGROUND

• Cox AE, Ullrich-French S, Howe HS, Cole AN. A pilot yoga physical education curriculum to promote positive body image. Body Image. 2017 Dec;23:1-8. doi: 10.1016/j.bodyim.2017.07.007. Epub 2017 Aug 14.

  PMID: 28818786 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Achenbach TM, Ruffle TM. The Child Behavior Checklist and related forms for assessing behavioral/emotional problems and competencies. Pediatr Rev. 2000 Aug;21(8):265-71. doi: 10.1542/pir.21-8-265. No abstract available.

  PMID: 10922023 BACKGROUND

Study Officials

• Morgan Vigil-Hayes, PhD

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan Vigil-Hayes, PhD

CONTACT

9285234863; morgan.vigil-hayes@nau.edu

Marissa Adams, MPH

CONTACT

marissa.adams@nau.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 12, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 23, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)