NCT06254872

Brief 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 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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jul 2024Oct 2026

First Submitted

Initial submission to the registry

January 29, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 23, 2025

Status Verified

August 1, 2024

Enrollment Period

2.2 years

First QC Date

January 29, 2024

Last Update Submit

January 21, 2025

Conditions

Keywords

American Indian / Alaska Nativepeer mentor

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

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

    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.

    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.

    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.

    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.

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

  • +1 more secondary outcomes

Study Arms (1)

Peer Mentors

EXPERIMENTAL

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.

Behavioral: Peer Mentors

Interventions

Peer MentorsBEHAVIORAL

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

Also known as: Sunrise Peer Mentors
Peer Mentors

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Has not completed GED/High School Diploma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

ACTIVE NOT RECRUITING

Northern Arizona University

Flagstaff, Arizona, 86011, United States

RECRUITING

Related Publications (7)

  • 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: 34676359BACKGROUND
  • 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: 32455346BACKGROUND
  • 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: 27199794BACKGROUND
  • 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: 6668417BACKGROUND
  • 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: 28818786BACKGROUND
  • 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: 18504506BACKGROUND
  • 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: 11556941BACKGROUND

Study Officials

  • Morgan Vigil-Hayes, PhD

    Northern Arizona University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan Vigil-Hayes, PhD

CONTACT

Marissa Adams, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 12, 2024

Study Start

July 31, 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

Individual participants will be from a small, rural community and confidentiality can be easily breached if individual participant data is revealed.

Locations