Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health
Primary Purpose
Depression, Anxiety, Suicidal Ideation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Knowing Who You Are (Becoming): Cultural Identity Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Cultural Identity, Sense of Community, Wellbeing, Alaska Native
Eligibility Criteria
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:
-
Sites / Locations
- University of Alaska Anchorage
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention in Fall 2020
Intervention in Spring 2021
Arm Description
Participants will receive the intervention in Fall 2020
Control in Fall 2020
Outcomes
Primary Outcome Measures
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Academic Achievement at Baseline
Grade point average (GPA) for a given semester.
Change in Baseline Academic Achievement Immediately Following Intervention
Grade point average (GPA) for a given semester.
Change in Post-Intervention Academic Achievement at 1-Year Follow-Up
Grade point average (GPA) for a given semester.
Rate of Students Maintaining University Enrollment Semester of Intervention
Enrollment for a given semester.
Rate of Students Maintaining University Enrollment Semester after Intervention
Enrollment for a given semester.
Rate of Students Maintaining University Enrollment One Year Post-Intervention
Enrollment for a given semester.
Full Information
NCT ID
NCT04561544
First Posted
August 30, 2020
Last Updated
May 18, 2023
Sponsor
University of Alaska Anchorage
Collaborators
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT04561544
Brief Title
Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health
Official Title
Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2020 (Actual)
Primary Completion Date
May 5, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alaska Anchorage
Collaborators
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Suicidal Ideation, Substance Use
Keywords
Cultural Identity, Sense of Community, Wellbeing, Alaska Native
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention in Fall 2020
Arm Type
Experimental
Arm Description
Participants will receive the intervention in Fall 2020
Arm Title
Intervention in Spring 2021
Arm Type
Other
Arm Description
Control in Fall 2020
Intervention Type
Behavioral
Intervention Name(s)
Knowing Who You Are (Becoming): Cultural Identity Intervention
Intervention Description
8-week cultural identity development program led by Alaska Native Elders
Primary Outcome Measure Information:
Title
Degree of Identification with Cultural Identity at Baseline
Description
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
Time Frame
Baseline, Pre-Intervention
Title
Change in Baseline Degree of Identification with Cultural Identity Immediately Following Intervention
Description
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
Time Frame
Immediately After Intervention
Title
Change in Post-Intervention Degree of Identification with Cultural Identity at 6-Month Follow-Up
Description
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
Time Frame
Follow-Up, Approximately 6 Months After Intervention
Title
Degree of Identification with Cultural Strengths at Baseline
Description
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.
Time Frame
Baseline, Pre-Intervention
Title
Change in Baseline Degree of Identification with Cultural Strengths Immediately Following Intervention
Description
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.
Time Frame
Immediately After Intervention
Title
Change in Post-Intervention Degree of Identification with Cultural Strengths at 6-Month Follow-Up
Description
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.
Time Frame
Follow-Up, Approximately 6 Months After Intervention
Title
Strength of Sense of Community with Alaska Native People at University at Baseline
Description
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.
Time Frame
Baseline, Pre-Intervention
Title
Change in Baseline Strength of Sense of Community with Alaska Native People at University Immediately Following Intervention
Description
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.
Time Frame
Immediately After Intervention
Title
Change in Post-Intervention Strength of Sense of Community with Alaska Native People at University at 6-Month Follow-Up
Description
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.
Time Frame
Follow-Up, Approximately 6 Months After Intervention
Title
Degree of Wellbeing at Baseline
Description
Wellbeing scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate greater wellbeing.
Time Frame
Baseline, Pre-Intervention
Title
Change in Baseline Degree of Wellbeing Immediately Following Intervention
Description
Wellbeing scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate greater wellbeing.
Time Frame
Immediately After Intervention
Title
Change in Post-Intervention Degree of Wellbeing at 6-Month Follow-Up
Description
Wellbeing scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate greater wellbeing.
Time Frame
Follow-Up, Approximately 6 Months After Intervention
Title
Degree of Anxiety Symptoms at Baseline
Description
Anxiety scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more anxiety.
Time Frame
Baseline, Pre-Intervention
Title
Change in Baseline Degree of Anxiety Symptoms Immediately Following Intervention
Description
Anxiety scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more anxiety.
Time Frame
Immediately After Intervention
Title
Change in Post-Intervention Degree of Anxiety Symptoms at 6-Month Follow-Up
Description
Anxiety scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more anxiety.
Time Frame
Follow-Up, Approximately 6 Months After Intervention
Title
Degree of Depression Symptoms at Baseline
Description
Depression scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more depression.
Time Frame
Baseline, Pre-Intervention
Title
Change in Baseline Degree of Depression Symptoms Immediately Following Intervention
Description
Depression scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more depression.
Time Frame
Immediately After Intervention
Title
Change in Post-Intervention Degree of Depression Symptoms at 6-Month Follow-Up
Description
Depression scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more depression.
Time Frame
Follow-Up, Approximately 6 Months After Intervention
Title
Degree of Suicidality Symptoms at Baseline
Description
Suicidality scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more suicidality.
Time Frame
Baseline, Pre-Intervention
Title
Change in Baseline Degree of Suicidality Symptoms Immediately Following Intervention
Description
Suicidality scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more suicidality.
Time Frame
Immediately After Intervention
Title
Change in Post-Intervention Degree of Suicidality Symptoms at 6-Month Follow-Up
Description
Suicidality scale of the Mental Health Inventory (Veit & Ware, 1983). Converted scores range from 0-100, higher scores indicate more suicidality.
Time Frame
Follow-Up, Approximately 6 Months After Intervention
Title
Degree of Substance Use at Baseline
Description
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.
Time Frame
Baseline, Pre-Intervention
Title
Change in Baseline Degree of Substance Use Immediately Following Intervention
Description
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.
Time Frame
Immediately After Intervention
Title
Change in Post-Intervention Degree of Substance Use at 6-Month Follow-Up
Description
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.
Time Frame
Follow-Up, Approximately 6 Months After Intervention
Secondary Outcome Measure Information:
Title
Academic Achievement at Baseline
Description
Grade point average (GPA) for a given semester.
Time Frame
Baseline, Pre-Intervention
Title
Change in Baseline Academic Achievement Immediately Following Intervention
Description
Grade point average (GPA) for a given semester.
Time Frame
Immediately After Intervention
Title
Change in Post-Intervention Academic Achievement at 1-Year Follow-Up
Description
Grade point average (GPA) for a given semester.
Time Frame
Follow-Up, Approximately 12 Months After Intervention
Title
Rate of Students Maintaining University Enrollment Semester of Intervention
Description
Enrollment for a given semester.
Time Frame
Immediately After Intervention
Title
Rate of Students Maintaining University Enrollment Semester after Intervention
Description
Enrollment for a given semester.
Time Frame
Follow-Up, Approximately 6 Months After Intervention
Title
Rate of Students Maintaining University Enrollment One Year Post-Intervention
Description
Enrollment for a given semester.
Time Frame
Follow-Up, Approximately 12 Months After Intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Facility Information:
Facility Name
University of Alaska Anchorage
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health
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