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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06254872
Other study ID # 2125144
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date August 2024

Study information

Verified date January 2024
Source Northern Arizona University
Contact Morgan Vigil-Hayes, PhD
Phone 9285234863
Email morgan.vigil-hayes@nau.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 4
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Northern Arizona University University of Colorado, Denver

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
Secondary 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.
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
Secondary 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.
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
Secondary 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.
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
Secondary 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.
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
Secondary 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.
Baseline, 6 weeks after starting as a mentor, 12 weeks after starting as a mentor
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