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DepressionNCT04561544

Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health

A study testing Knowing Who You Are (Becoming): Cultural Identity Intervention in people with Depression and Anxiety, run by University of Alaska Anchorage at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Depression, Anxiety, Suicidal Ideation
What is being tested?
Knowing Who You Are (Becoming): Cultural Identity Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
30 Aug 2020to 31 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • self-identify as Alaska Native,
  • are registered as an undergraduate student at UAA,
  • are at least 18 years old,
  • speak English

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alaska Anchorage

    Anchorage, Alaska, 99508

Other trials in United States

About this study

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).

Being tested
Knowing Who You Are (Becoming): Cultural Identity Intervention
Keywords
Cultural Identity, Sense of Community, Wellbeing, Alaska Native
Medical subject headings
Depression, Anxiety Disorders, Suicidal Ideation, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Knowing Who You Are (Becoming): Cultural Identity InterventionBehavioural

    8-week cultural identity development program led by Alaska Native Elders

Study groups in NCT04561544
Study groupRoleWhat they receive
Intervention in Fall 2020ExperimentalParticipants will receive the intervention in Fall 2020
Receives: Behavioral: Knowing Who You Are (Becoming): Cultural Identity Intervention
Intervention in Spring 2021OtherControl in Fall 2020
Receives: Behavioral: Knowing Who You Are (Becoming): Cultural Identity Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, Pre-Intervention

  2. 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

    Measured: Immediately After Intervention

  3. 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

    Measured: Follow-Up, Approximately 6 Months After Intervention

  4. 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.

    Measured: Baseline, Pre-Intervention

  5. 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.

    Measured: Immediately After Intervention

  6. 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.

    Measured: Follow-Up, Approximately 6 Months After Intervention

  7. 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.

    Measured: Baseline, Pre-Intervention

  8. 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.

    Measured: Immediately After Intervention

  9. 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.

    Measured: Follow-Up, Approximately 6 Months After Intervention

  10. 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.

    Measured: Baseline, Pre-Intervention

  11. 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.

    Measured: Immediately After Intervention

  12. 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.

    Measured: Follow-Up, Approximately 6 Months After Intervention

  13. 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.

    Measured: Baseline, Pre-Intervention

  14. 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.

    Measured: Immediately After Intervention

  15. 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.

    Measured: Follow-Up, Approximately 6 Months After Intervention

  16. 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.

    Measured: Baseline, Pre-Intervention

  17. 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.

    Measured: Immediately After Intervention

  18. 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.

    Measured: Follow-Up, Approximately 6 Months After Intervention

  19. 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.

    Measured: Baseline, Pre-Intervention

  20. 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.

    Measured: Immediately After Intervention

  21. 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.

    Measured: Follow-Up, Approximately 6 Months After Intervention

  22. 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.

    Measured: Baseline, Pre-Intervention

  23. 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.

    Measured: Immediately After Intervention

  24. 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.

    Measured: Follow-Up, Approximately 6 Months After Intervention

Secondary outcomes (6)
  1. Academic Achievement at Baseline

    Grade point average (GPA) for a given semester.

    Measured: Baseline, Pre-Intervention

  2. Change in Baseline Academic Achievement Immediately Following Intervention

    Grade point average (GPA) for a given semester.

    Measured: Immediately After Intervention

  3. Change in Post-Intervention Academic Achievement at 1-Year Follow-Up

    Grade point average (GPA) for a given semester.

    Measured: Follow-Up, Approximately 12 Months After Intervention

  4. Rate of Students Maintaining University Enrollment Semester of Intervention

    Enrollment for a given semester.

    Measured: Immediately After Intervention

  5. Rate of Students Maintaining University Enrollment Semester after Intervention

    Enrollment for a given semester.

    Measured: Follow-Up, Approximately 6 Months After Intervention

  6. Rate of Students Maintaining University Enrollment One Year Post-Intervention

    Enrollment for a given semester.

    Measured: Follow-Up, Approximately 12 Months After Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2020
  2. Study start30 Aug 2020
  3. Primary completion5 May 2021
  4. Study completion31 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04561544
Sponsor's protocol ID
1210302
Other IDs
U54GM115371
Status last verified
Dec 2023
First submitted
30 Aug 2020
Last updated
11 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Knowing Who You Are (Becoming): Cultural Identity Intervention in people with Depression and Anxiety, run by University of Alaska Anchorage at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of Identification with Cultural Identity at Baseline (time frame: Baseline, Pre-Intervention). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.

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