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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04561544
Other study ID # 1210302
Secondary ID U54GM115371
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2020
Est. completion date May 31, 2022

Study information

Verified date December 2023
Source University of Alaska Anchorage
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project aims to enhance AN university students' behavioral health by supporting their cultural identity development. While the connection between cultural identity and behavioral health is becoming clearer, comparably less research has explored methods of enhancing identity development. Consequently, the investigators will pilot a cultural identity development program for AN students at the University of Alaska Anchorage (UAA). This intervention is based on extant scientific literature, local findings from focus group with AN students, and traditional wisdom from AN Elders. The eight-week Elder-facilitated program incorporates storytelling, experiential learning, connection, exploration, and sharing of identity, cultural strengths, life paths, and rootedness in who they are in order to remain grounded when they face changes and challenges. Approximately 40 to 50 AN university students will be recruited for the intervention. Participants will be randomized, with half the participants receiving the intervention in the Fall 2020 semester and half the students receiving the intervention in the Spring 2021 semester. We hypothesize that engaging in this intervention will strengthen AN students' cultural identities, strengths, and sense of community; improve their behavioral health, as evidenced in higher self-reported wellbeing, and lower substance use, depression, anxiety, and suicidal ideation symptoms; and support their academic persistence and achievement. Outcomes will be tested via mixed design analyses of covariance. Moreover, program feasibility will be examined through a process evaluation, which will entail thematic analyses of six focus groups with program participants (n=40-50) and with the Elders who facilitated the program (n=5).


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date May 31, 2022
Est. primary completion date May 5, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - self-identify as Alaska Native, - are registered as an undergraduate student at UAA, - are at least 18 years old, - speak English Exclusion Criteria: -

Study Design


Intervention

Behavioral:
Knowing Who You Are (Becoming): Cultural Identity Intervention
8-week cultural identity development program led by Alaska Native Elders

Locations

Country Name City State
United States University of Alaska Anchorage Anchorage Alaska

Sponsors (2)

Lead Sponsor Collaborator
University of Alaska Anchorage National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of Identification with Cultural Identity at Baseline Multigroup Ethnic Identity Measure (Roberts et al., 1999), a 12-item self-report measure developed for diverse groups that has been validated with Native people (e.g., Moran et al., 1999) to measure cultural identity. Range = 6-30, higher scores indicate greater identification with cultural identity Baseline, Pre-Intervention
Primary Change in Baseline Degree of Identification with Cultural Identity Immediately Following Intervention Multigroup Ethnic Identity Measure (Roberts et al., 1999), a 12-item self-report measure developed for diverse groups that has been validated with Native people (e.g., Moran et al., 1999) to measure cultural identity. Range = 6-30, higher scores indicate greater identification with cultural identity Immediately After Intervention
Primary Change in Post-Intervention Degree of Identification with Cultural Identity at 6-Month Follow-Up Multigroup Ethnic Identity Measure (Roberts et al., 1999), a 12-item self-report measure developed for diverse groups that has been validated with Native people (e.g., Moran et al., 1999) to measure cultural identity. Range = 6-30, higher scores indicate greater identification with cultural identity Follow-Up, Approximately 6 Months After Intervention
Primary Degree of Identification with Cultural Strengths at Baseline Native Cultural Health Assessment Tool (White Shield, 2013), a 10-item self-report measure of cultural strengths in given time period (past month for project) that was developed for Native people to measure cultural strengths. Range = 10-50, higher scores indicate greater identification with cultural strengths. Baseline, Pre-Intervention
Primary Change in Baseline Degree of Identification with Cultural Strengths Immediately Following Intervention Native Cultural Health Assessment Tool (White Shield, 2013), a 10-item self-report measure of cultural strengths in given time period (past month for project) that was developed for Native people to measure cultural strengths. Range = 10-50, higher scores indicate greater identification with cultural strengths. Immediately After Intervention
Primary Change in Post-Intervention Degree of Identification with Cultural Strengths at 6-Month Follow-Up Native Cultural Health Assessment Tool (White Shield, 2013), a 10-item self-report measure of cultural strengths in given time period (past month for project) that was developed for Native people to measure cultural strengths. Range = 10-50, higher scores indicate greater identification with cultural strengths. Follow-Up, Approximately 6 Months After Intervention
Primary Strength of Sense of Community with Alaska Native People at University at Baseline Sense of Community Index, Second Edition (Chavis et al., 2008), a 24-item self-report measure of membership in, shared emotional connection with, fulfillment of needs from, and mutual influence on a given community (e.g., Alaska Native community at UAA) that has been used with diverse populations. Range = 0-72, higher scores indicate greater sense of community. Baseline, Pre-Intervention
Primary Change in Baseline Strength of Sense of Community with Alaska Native People at University Immediately Following Intervention Sense of Community Index, Second Edition (Chavis et al., 2008), a 24-item self-report measure of membership in, shared emotional connection with, fulfillment of needs from, and mutual influence on a given community (e.g., Alaska Native community at UAA) that has been used with diverse populations. Range = 0-72, higher scores indicate greater sense of community. Immediately After Intervention
Primary Change in Post-Intervention Strength of Sense of Community with Alaska Native People at University at 6-Month Follow-Up Sense of Community Index, Second Edition (Chavis et al., 2008), a 24-item self-report measure of membership in, shared emotional connection with, fulfillment of needs from, and mutual influence on a given community (e.g., Alaska Native community at UAA) that has been used with diverse populations. Range = 0-72, higher scores indicate greater sense of community. Follow-Up, Approximately 6 Months After Intervention
Primary Degree of Wellbeing at Baseline Wellbeing scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate greater wellbeing. Baseline, Pre-Intervention
Primary Change in Baseline Degree of Wellbeing Immediately Following Intervention Wellbeing scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate greater wellbeing. Immediately After Intervention
Primary Change in Post-Intervention Degree of Wellbeing at 6-Month Follow-Up Wellbeing scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate greater wellbeing. Follow-Up, Approximately 6 Months After Intervention
Primary Degree of Anxiety Symptoms at Baseline Anxiety scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more anxiety. Baseline, Pre-Intervention
Primary Change in Baseline Degree of Anxiety Symptoms Immediately Following Intervention Anxiety scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more anxiety. Immediately After Intervention
Primary Change in Post-Intervention Degree of Anxiety Symptoms at 6-Month Follow-Up Anxiety scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more anxiety. Follow-Up, Approximately 6 Months After Intervention
Primary Degree of Depression Symptoms at Baseline Depression scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more depression. Baseline, Pre-Intervention
Primary Change in Baseline Degree of Depression Symptoms Immediately Following Intervention Depression scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more depression. Immediately After Intervention
Primary Change in Post-Intervention Degree of Depression Symptoms at 6-Month Follow-Up Depression scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more depression. Follow-Up, Approximately 6 Months After Intervention
Primary Degree of Suicidality Symptoms at Baseline Suicidality scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more suicidality. Baseline, Pre-Intervention
Primary Change in Baseline Degree of Suicidality Symptoms Immediately Following Intervention Suicidality scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more suicidality. Immediately After Intervention
Primary Change in Post-Intervention Degree of Suicidality Symptoms at 6-Month Follow-Up Suicidality scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more suicidality. Follow-Up, Approximately 6 Months After Intervention
Primary Degree of Substance Use at Baseline Items from the Monitoring the Future Survey (U. Michigan), a 9-item self-report measure of tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, and opioid use in past 30 days. Higher scores indicate greater substance use. Baseline, Pre-Intervention
Primary Change in Baseline Degree of Substance Use Immediately Following Intervention Items from the Monitoring the Future Survey (U. Michigan), a 9-item self-report measure of tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, and opioid use in past 30 days. Higher scores indicate greater substance use. Immediately After Intervention
Primary Change in Post-Intervention Degree of Substance Use at 6-Month Follow-Up Items from the Monitoring the Future Survey (U. Michigan), a 9-item self-report measure of tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, and opioid use in past 30 days. Higher scores indicate greater substance use. Follow-Up, Approximately 6 Months After Intervention
Secondary Academic Achievement at Baseline Grade point average (GPA) for a given semester. Baseline, Pre-Intervention
Secondary Change in Baseline Academic Achievement Immediately Following Intervention Grade point average (GPA) for a given semester. Immediately After Intervention
Secondary Change in Post-Intervention Academic Achievement at 1-Year Follow-Up Grade point average (GPA) for a given semester. Follow-Up, Approximately 12 Months After Intervention
Secondary Rate of Students Maintaining University Enrollment Semester of Intervention Enrollment for a given semester. Immediately After Intervention
Secondary Rate of Students Maintaining University Enrollment Semester after Intervention Enrollment for a given semester. Follow-Up, Approximately 6 Months After Intervention
Secondary Rate of Students Maintaining University Enrollment One Year Post-Intervention Enrollment for a given semester. Follow-Up, Approximately 12 Months After Intervention
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