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Mental Health Wellness 1NCT06254872

Qoyangnuptu: Peer Mentor

A study testing Peer Mentors in people with Mental Health Wellness 1, run by Northern Arizona University at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Mental Health Wellness 1
What is being tested?
Peer Mentors
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
2 sitesUnited States
Study dates
31 Jul 2024to 1 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Member of Southwestern Tribal Community
  • Has a smartphone
  • Has access to the Internet with the smartphone at least once per day

Who cannot join

  • Has not completed GED/High School Diploma

Trial locations and contacts

2 sites in 1 country.

Morgan Vigil-Hayes, PhD contact

9285234863

morgan.vigil-hayes@nau.edu

Marissa Adams, MPH contact

marissa.adams@nau.edu

United States2 sites, 1 recruiting

  • Northern Arizona University

    Flagstaff, Arizona, 86011

    Active, not recruiting

  • Northern Arizona University

    Flagstaff, Arizona, 86011

    Morgan Vigil-Hayes, PhD, 9285234863, morgan.vigil-hayes@nau.edu

    Marissa Adams, MPH, marisa.adams@nau.edu

    Recruiting

Other trials in United States

About this study

Official title: 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?
Read more

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
Being tested
Peer Mentors
Keywords
American Indian / Alaska Native, peer mentor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer MentorsBehavioural

    Also called Sunrise Peer Mentors

    Peer mentors provide daily guidance and encouragement to mentees via smartphone app based on training.

Study groups in NCT06254872
Study groupRoleWhat they receive
Peer MentorsExperimentalParticipants 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.
Receives: Behavioral: Peer Mentors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To measure the acceptability of the Peer Mentorship Program

    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.

    Measured: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor

Secondary outcomes (6)

  1. Impact of participation in Peer Mentorship Program as Peer Mentor on attitudes towards seeking professional mental health assistance.

    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.

    Measured: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor

  2. Impact of participation in Peer Mentorship Program as Peer Mentor on measures of depression.

    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.

    Measured: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor

  3. Impact of participation in Peer Mentorship Program as Peer Mentor on measures of stress.

    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.

    Measured: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor

  4. Impact of participation in Peer Mentorship Program as Peer Mentor on measures of mindfulness.

    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.

    Measured: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor

  5. Impact of participation in Peer Mentorship Program as Peer Mentor on measures of quiet ego.

    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.

    Measured: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor

  6. Impact of participation in Peer Mentorship Program as Peer Mentor on measures of social connectedness.

    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.

    Measured: Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start31 Jul 2024
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06254872
Sponsor's protocol ID
2125144
Status last verified
Aug 2024
First submitted
29 Jan 2024
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participants will be from a small, rural community and confidentiality can be easily breached if individual participant data is revealed.

Publications

  • 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.

    PubMed 34676359

  • 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.

    PubMed 32455346

  • 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.

    PubMed 27199794

  • 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.

    PubMed 6668417

  • 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.

    PubMed 28818786

  • 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.

    PubMed 18504506

  • 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.

    PubMed 11556941

Questions about this trial

What is this clinical trial studying?

A study testing Peer Mentors in people with Mental Health Wellness 1, run by Northern Arizona University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Morgan Vigil-Hayes, PhD (9285234863, morgan.vigil-hayes@nau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06254872, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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