- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04561544
Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health
December 5, 2023 updated by: Sara Buckingham, University of Alaska Anchorage
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alaska
-
Anchorage, Alaska, United States, 99508
- University of Alaska Anchorage
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention in Fall 2020
Participants will receive the intervention in Fall 2020
|
8-week cultural identity development program led by Alaska Native Elders
|
|
Other: Intervention in Spring 2021
Control in Fall 2020
|
8-week cultural identity development program led by Alaska Native Elders
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of Identification with Cultural Identity at Baseline
Time Frame: Baseline, Pre-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
|
Baseline, Pre-Intervention
|
|
Change in Baseline Degree of Identification with Cultural Identity Immediately Following Intervention
Time Frame: Immediately After 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
|
|
Change in Post-Intervention Degree of Identification with Cultural Identity at 6-Month Follow-Up
Time Frame: Follow-Up, Approximately 6 Months After 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
|
Follow-Up, Approximately 6 Months After Intervention
|
|
Degree of Identification with Cultural Strengths at Baseline
Time Frame: Baseline, Pre-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.
|
Baseline, Pre-Intervention
|
|
Change in Baseline Degree of Identification with Cultural Strengths Immediately Following Intervention
Time Frame: Immediately After 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
|
|
Change in Post-Intervention Degree of Identification with Cultural Strengths at 6-Month Follow-Up
Time Frame: Follow-Up, Approximately 6 Months After 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.
|
Follow-Up, Approximately 6 Months After Intervention
|
|
Strength of Sense of Community with Alaska Native People at University at Baseline
Time Frame: Baseline, Pre-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.
|
Baseline, Pre-Intervention
|
|
Change in Baseline Strength of Sense of Community with Alaska Native People at University Immediately Following Intervention
Time Frame: Immediately After 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
|
|
Change in Post-Intervention Strength of Sense of Community with Alaska Native People at University at 6-Month Follow-Up
Time Frame: Follow-Up, Approximately 6 Months After 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.
|
Follow-Up, Approximately 6 Months After Intervention
|
|
Degree of Wellbeing at Baseline
Time Frame: Baseline, Pre-Intervention
|
Wellbeing scale of the Mental Health Inventory (Veit & Ware, 1983).
Converted scores range from 0-100, higher scores indicate greater wellbeing.
|
Baseline, Pre-Intervention
|
|
Change in Baseline Degree of Wellbeing Immediately Following Intervention
Time Frame: Immediately After 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
|
|
Change in Post-Intervention Degree of Wellbeing at 6-Month Follow-Up
Time Frame: Follow-Up, Approximately 6 Months After Intervention
|
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
|
|
Degree of Anxiety Symptoms at Baseline
Time Frame: Baseline, Pre-Intervention
|
Anxiety scale of the Mental Health Inventory (Veit & Ware, 1983).
Converted scores range from 0-100, higher scores indicate more anxiety.
|
Baseline, Pre-Intervention
|
|
Change in Baseline Degree of Anxiety Symptoms Immediately Following Intervention
Time Frame: Immediately After 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
|
|
Change in Post-Intervention Degree of Anxiety Symptoms at 6-Month Follow-Up
Time Frame: Follow-Up, Approximately 6 Months After Intervention
|
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
|
|
Degree of Depression Symptoms at Baseline
Time Frame: Baseline, Pre-Intervention
|
Depression scale of the Mental Health Inventory (Veit & Ware, 1983).
Converted scores range from 0-100, higher scores indicate more depression.
|
Baseline, Pre-Intervention
|
|
Change in Baseline Degree of Depression Symptoms Immediately Following Intervention
Time Frame: Immediately After 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
|
|
Change in Post-Intervention Degree of Depression Symptoms at 6-Month Follow-Up
Time Frame: Follow-Up, Approximately 6 Months After Intervention
|
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
|
|
Degree of Suicidality Symptoms at Baseline
Time Frame: Baseline, Pre-Intervention
|
Suicidality scale of the Mental Health Inventory (Veit & Ware, 1983).
Converted scores range from 0-100, higher scores indicate more suicidality.
|
Baseline, Pre-Intervention
|
|
Change in Baseline Degree of Suicidality Symptoms Immediately Following Intervention
Time Frame: Immediately After 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
|
|
Change in Post-Intervention Degree of Suicidality Symptoms at 6-Month Follow-Up
Time Frame: Follow-Up, Approximately 6 Months After Intervention
|
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
|
|
Degree of Substance Use at Baseline
Time Frame: Baseline, Pre-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.
|
Baseline, Pre-Intervention
|
|
Change in Baseline Degree of Substance Use Immediately Following Intervention
Time Frame: Immediately After 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
|
|
Change in Post-Intervention Degree of Substance Use at 6-Month Follow-Up
Time Frame: Follow-Up, Approximately 6 Months After 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.
|
Follow-Up, Approximately 6 Months After Intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Academic Achievement at Baseline
Time Frame: Baseline, Pre-Intervention
|
Grade point average (GPA) for a given semester.
|
Baseline, Pre-Intervention
|
|
Change in Baseline Academic Achievement Immediately Following Intervention
Time Frame: Immediately After Intervention
|
Grade point average (GPA) for a given semester.
|
Immediately After Intervention
|
|
Change in Post-Intervention Academic Achievement at 1-Year Follow-Up
Time Frame: Follow-Up, Approximately 12 Months After Intervention
|
Grade point average (GPA) for a given semester.
|
Follow-Up, Approximately 12 Months After Intervention
|
|
Rate of Students Maintaining University Enrollment Semester of Intervention
Time Frame: Immediately After Intervention
|
Enrollment for a given semester.
|
Immediately After Intervention
|
|
Rate of Students Maintaining University Enrollment Semester after Intervention
Time Frame: Follow-Up, Approximately 6 Months After Intervention
|
Enrollment for a given semester.
|
Follow-Up, Approximately 6 Months After Intervention
|
|
Rate of Students Maintaining University Enrollment One Year Post-Intervention
Time Frame: Follow-Up, Approximately 12 Months After Intervention
|
Enrollment for a given semester.
|
Follow-Up, Approximately 12 Months After Intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2020
Primary Completion (Actual)
May 5, 2021
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
August 30, 2020
First Submitted That Met QC Criteria
September 18, 2020
First Posted (Actual)
September 23, 2020
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1210302
- U54GM115371 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States