- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06254872
Qoyangnuptu: Peer Mentor
Qoyangnuptu: Peer Mentor Pilot 1
The goal of this clinical trial is to learn about the impacts of participating in a peer mentor program in 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:
- Be trained as peer mentors
- Be trained in how to use the QI App to communicate with mentees
- Guide daily conversation prompts with a group of 3 mentees via the QI App
- Provide daily encouragement to mentees to engage with mindfulness activities on the QI App
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Morgan Vigil-Hayes, PhD
- Phone Number: 9285234863
- Email: morgan.vigil-hayes@nau.edu
Study Contact Backup
- Name: Marissa Adams, MPH
- Email: marissa.adams@nau.edu
Study Locations
-
-
Arizona
-
Flagstaff, Arizona, United States, 86011
- Recruiting
- Northern Arizona University
-
Contact:
- Morgan Vigil-Hayes, PhD
- Phone Number: 9285234863
- Email: morgan.vigil-hayes@nau.edu
-
Contact:
- Morgan Vigil-Hayes, PhD
-
Contact:
- Marissa Adams, MPH
- Email: marisa.adams@nau.edu
-
Flagstaff, Arizona, United States, 86011
- Active, not recruiting
- Northern Arizona University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Member of Southwestern Tribal Community
- Has a smartphone
- Has access to the Internet with the smartphone at least once per day
Exclusion Criteria:
- Has not completed GED/High School Diploma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer Mentors
Participants will be trained in how to be peer mentors to anonymous participants through a smartphone app.
Participants will provide daily prompts to their mentees to encourage anonymous discussion in the group chat feature of the smartphone app.
Participants will provide daily encouragement to their mentees to use features of the smartphone app to practice mindfulness skills.
|
Peer mentors provide daily guidance and encouragement to mentees via smartphone app based on training.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To measure the acceptability of the Peer Mentorship Program
Time Frame: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
Through qualitative interviews, the investigators will determine the acceptability of the Peer Mentorship Program. 4 participants will be interviewed after they have participated in the Peer Mentorship Program as Peer Mentors for 6 weeks.
|
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of participation in Peer Mentorship Program as Peer Mentor on attitudes towards seeking professional mental health assistance.
Time Frame: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
Measured by the Attitudes Towards Seeking Professional Psychological Help - Short Form Scale before participating as a Peer Mentor, 6 weeks into participating as a Peer Mentor, and 12 weeks after starting as a peer mentor. The Attitudes Towards Seeking Professional Psychological Help is a 10-item measure used to assess attitudes towards seeking professional psychological help on a 4-point Likert scale, ranging from 0 to 3. Higher total score indicates more positive attitudes towards seeking seeking professional psychological help and is associated with lower levels of stigma against mental illness. |
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
|
Impact of participation in Peer Mentorship Program as Peer Mentor on measures of depression.
Time Frame: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
Patient Health Questionnaire-9 before participating as a Peer Mentor, 6 weeks into participation as a Peer Mentor, and 12 weeks after starting as a peer mentor. The Patient Health Questionnaire-9 is a 9-item measure used to assess frequency that a participant experiences depressive symptoms. Each item is score on a 4-point scale from 0 ("not at all") to 3 ("every day"). Higher total scores indicate more frequent experience of depressive symptoms. |
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
|
Impact of participation in Peer Mentorship Program as Peer Mentor on measures of stress.
Time Frame: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
Perceived Stress Scale 4 before participating as a Peer Mentor, 6 weeks into participation as a Peer Mentor, and 12 weeks after starting as a peer mentor. The Perceived Stress Scale 4 measures participant perceptions of their thoughts and feelings over the past month on 4 items. Each item is scored on a 5-point scale from from 0 ("Never") to 4 ("Very Often"). Higher scores indicate higher levels of stress. |
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
|
Impact of participation in Peer Mentorship Program as Peer Mentor on measures of mindfulness.
Time Frame: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
State Mindfulness Scale Physical Activity before participating as a Peer Mentor, 6 weeks into participation as a Peer Mentor, and 12 weeks after starting as a peer mentor. The State Mindfulness Physical Activity scale is a 12 item measure with six items assessing state mindfulness of the mind (i.e., thoughts and emotions) and six items assessing state mindfulness of the body (i.e., movement, body sensations, muscle engagement). The response scale is 0 - 4, with anchors of Not at all (0) and Very much (4). Initial evidence supports a bi-factor structure of the measure in which both a general state mindfulness factor and two specific factors (mind and body) are supported. The bi-factor structure supports the use of using a single score to capture overall state mindfulness, but also the use of two scores capture mindfulness of the mind and mindfulness of the body. |
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
|
Impact of participation in Peer Mentorship Program as Peer Mentor on measures of quiet ego.
Time Frame: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
Quiet Ego Scale before participating as a Peer Mentor, 6 weeks into participation as a Peer Mentor, and 12 weeks after starting as a peer mentor. The Quiet Ego Scale is a 14 item measure that assesses detached awareness, inclusive identity, perspective taking, and growth. Each item is assessed on a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). A higher score indicates a stronger quiet ego. |
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
|
Impact of participation in Peer Mentorship Program as Peer Mentor on measures of social connectedness.
Time Frame: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
University of California Los Angeles Loneliness Scale 3 before participating as a Peer Mentor, 6 weeks into participation as a Peer Mentor, and 12 weeks after starting as a peer mentor. The Loneliness Scale 3 comprises 3 questions that measure 3 dimensions of loneliness: relational connectedness, social connectedness, and self-perceived isolation. Each item is measured on a 3-point scale from 1 ("Hardly Ever") to 3 ("Often"). Higher scores indicate greater perceptions of loneliness. |
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Morgan Vigil-Hayes, PhD, Northern Arizona University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2125144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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