Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2024-08-30
2026-10-01
Brief Summary
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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
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Detailed Description
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1. Recruitment The investigators will use a multipronged recruitment strategy. Recruitment will be carried out by the study team's Community Research Coordinator.
Because the QI App was designed with members of the Southwestern Tribal community as consultants, the investigators already have individual contact information for people who have stated they would like to be reached out to when the investigators are ready to recruit for the pilot. The investigators will use a direct email approach with these individuals.
Through the QI App design process, the study team encountered a number of individuals and organizations who indicated that they would like to share the recruitment posts on their social media when the time came for the pilot. The investigators will prepare a social media post that potential participants can share on their networks.
The investigators will work with their community research coordinator and their Senior Personnel and project consultants to help them post flyers strategically in the community.
When working with Indigenous communities, developing trust is paramount. One of the best ways for the investigators to successfully recruit is for individuals who have come to know and trust the study team reach out to others in their community to share information about the study and have them reach out to contact the study team to be formally recruited. Individuals who reach out to the study team via word-of-mouth will be followed up with using the Email Recruitment message.
2. Consent Process
Once individuals have made contact with the study team via recruitment effort, the investigators will plan to have a Zoom meeting with potential participants or in a reserved community meeting room to review the study details, answer questions, and obtain informed consent. This meeting will also require the participant to download and install the QI App to demonstrate that they can use it on their personal iPhone or Android device.
* If meeting over Zoom: The investigators will obtain consent through a Zoom oral consent statement. The investigators will email the consent form to participants or send to them via postal mail if they prefer.
* If meeting in-person: The investigators will reserve a community room where potential participants can meet with the study team's community researcher at a scheduled time to review the research process in a space that allows for confidentiality to be maintained. Participants will physically sign the consent form and be provided with a copy.
3. Research Activities
* QI App Users. The participants will be asked to complete a short demographic questionnaire and baseline survey. The participants will be asked to use the QI App for a total for 6 weeks. After the participants have completed the 6-week cohort, they will again complete the QI App user questionnaire (which combines all questionnaire measures for Secondary Study Objectives 1-6 in "Project Purpose" Section). They will also be asked to participate in a focus group with semi-structured interview questions where they will explain what they liked and did not like about the QI App and what they would change about the app and user experience. 12 weeks after the completion of the program (12 weeks from when they started using the app), participants will complete the QI App user questionnaire for the third time. Surveys can be distributed either as electronic surveys sent via email OR via physical delivery and pickup by the community research coordinator, whichever the subject prefers. Focus groups will be conducted either as Zoom sessions or in-person in a reserved community room, depending on the collective preference of participants.
* Parents of QI App Users. The participants will be asked to complete a short demographic questionnaire and baseline survey.. After the participant's child has completed the 6-week cohort, they will again complete the Parents of QI App user survey (which combines all questionnaire measures for Secondary Study Objectives 7-8 in "Project Purpose" Section). They will also be asked to participate in a focus group with semi-structured interview questions where they will explain what they liked and did not like about the QI App and what they would change about the app and user experience.12 weeks after the completion of the program (12 weeks from when they started using the app), participants will complete the QI App user questionnaire for the third time. Surveys can be distributed either as electronic surveys sent via email OR via physical delivery and pickup by the community research coordinator, whichever the subject prefers. Focus groups will be conducted either as Zoom sessions or in-person in a reserved community room, depending on the collective preference of participants.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QI App Users
Participants will be asked to use the QI App once per day for 5-10 minutes per day for 6 weeks.
QI App Users
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.
Parents/Guardians of QI App Users
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.
Parents/Guardians of QI App Users
Parents/Guardians of QI App users will be informed that their child is using the QI App for a 6-week period.
Interventions
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QI App Users
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.
Parents/Guardians of QI App Users
Parents/Guardians of QI App users will be informed that their child is using the QI App for a 6-week period.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
14 Years
25 Years
ALL
Yes
Sponsors
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Northern Arizona University
OTHER
Responsible Party
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Principal Investigators
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Morgan Vigil-Hayes, PhD
Role: PRINCIPAL_INVESTIGATOR
Northern Arizona University
Locations
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Northern Arizona University
Flagstaff, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2125143
Identifier Type: -
Identifier Source: org_study_id
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