Alaska Native Collaborative Hub for Resilience Research (ANCHRR)

April 24, 2017 updated by: Stacy Rasmus, University of Alaska Fairbanks

Alaska Native Resilience Research Study

The goal of the Alaska Native Resilience Research Study (ANRRS) is to identify community-level protective factors that can most effectively reduce co-occurring youth suicide and alcohol risk. The following specific aims will help us achieve this overarching goal. The research team will: (1): Assess the association of a set of modifiable cultural, community and institutional factors (protective community factors) with suicide, suicidal behaviors (ideation, attempt), and associated adverse outcomes (accidental death, alcohol-misuse requiring healthcare) in 64 rural and remote Alaska Native villages to identify community-level factors that are most predictive of youth health outcomes; (2): In a stratified random sample of six communities, use quantitative methods to test a multi-level model of individual-level youth protective factors as predictors of individual-level youth resilience from suicide risk outcomes; and (3): Develop and disseminate a method-Alaska Community Resilience Mapping (AK-CRM)-for communities to measure and strategically strengthen their protective capabilities to increase youth health and reduce the risk for suicide.

Methodology:

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The ANCHRR builds on our established tribal partnerships in the three regions of Alaska with the highest need for effective, culturally congruent and community-based suicide prevention. Drs. Rasmus and Allen have been working collaboratively with Yup'ik communities in the Yukon Kuskokwim region and Dr. Wexler has been doing community-based participatory research in Northwest Alaska (NWA) for 20 years. Both research teams have spent this time partnering with tribal communities and developing evidence-based and self-determined suicide prevention initiatives that reflect local, AN understandings and values, strengthen community systems of support, and build local capacity for strategic prevention practice. The collaborative hub will extend this successful partnership model to include all of the tribal health regions across the state. With relevance for all of rural Alaska, the Alaska Native Resilience Study will provide important insights into the community level factors-institutions, traditions, resources and leaders-and mechanisms-the community perceptions, practices and norms-that increase resilience from suicide and reduce risk. The resulting Alaska Community Resilience Mapping (AK-CRM) Tool will provide a user-friendly, visual representation of the community-level protective factors and processes, and will engage Alaska community members in identifying the community-level protective factors in their community and will offer scientifically-based recommendations for action. In this way, ANCHRR's proposed activities translate results from the research study into practical suggestions for tribal leaders, local practitioners and policy makers, to maximize its public health impact.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
585

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sixty-five Alaska Native communities (villages) will be drawn from a regional sample and individual study participants will be drawn from a community sample consisting of six Alaska Native villages across three regions.

Description

Inclusion Criteria:

  • To identify persons able to assess diverse community protective factors, we will identify at least 5 village members from each community who are: (a) local school board members or school workers, (b) community health aids, (c) village-based counselors, (d) tribal council members or tribal administrators, (e) city managers, (f) village public safety officers or village public officers, (g) postmasters, (h) Elder council members, and/or (i) religious leaders. This initial village list will also include other people who are informal leaders in the village.

Exclusion: From this list, participants will be screened to ensure: (1) village residence or service provision in the community for at least 5 years cumulatively and (2) endorsements from members of the Research Steering Committee, who are knowledgeable about specific community dynamics.

  • The sample of 64 communities will be stratified into higher, medium and lower protection community groups using their protective community factor score from Aim 1, then 6 communities will be randomly selected, 2 from each stratification group.
  • Children in each of 6 selected communities
  • All adults 18-29 in 6 selected communities.
  • Approximately 15 individual adults will be recruited in each of the six villages (n=60) through sampling the following sectors of community: government, church, social service, store/business, school, health care, parent, elder. We will contact individuals nominated in each sector by the local tribal council or their designate.

Exclusion Criteria:

  • Communities with fewer than 150 people will be excluded since the protective community dynamics and adverse outcomes are more stable in larger villages. This reduces the number of participating communities from 71 total number of villages to 65.
  • We will exclude children under the age of 15, because we seek information regarding late adolescence and beginning adulthood. We will exclude children who do not have the capacity to assent or to participate in the computerized survey.
  • We will exclude adults who do not have the capacity to consent or to participate in the computerized survey.
  • We will exclude adults who have lived in their respective village for less than 5 years, because we will be asking for information about community factors that require perspectives over time. We will exclude adults who do not have the capacity to consent or to participate in the computerized survey.

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

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Community Level Assessment
65 communities will undergo assessment of community / structural variables through review of public records and 3-5 key community interviewees per community.
Individual Level Assessment
A subset of 6 communities will be elected through a stratification process. Youth will complete a set of protective factors measures and outcomes. Adults will complete a section of the Neighborhood Matters survey.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Community Level Assessment: suicide and accidental deaths
Time Frame: Year 2
The Trauma Registry and the Alaska Violent Death Reporting System (AKVDRS) will be used to document suicide and accidental deaths
Year 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Individual Level Assessment: Youth: Individual: Communal Mastery Scale
Time Frame: Year 4
Collective efficacy: solving life challenges through joining with others
Year 4
Individual Level Assessment: Youth: Family: Family Relationship Scale
Time Frame: Year 4
Quality of family relationships
Year 4
Individual Level Assessment: Suicide Risk Resilience: Reasons for Life
Time Frame: Year 4
Alaska Native cultural beliefs and experiences that make life enjoyable, worthwhile, and provide meaning
Year 4
Community Level Assessment: Community Protective Factors
Time Frame: Year 2
A structured interview guide will ask community experts in each village about the extent to which protective factors related to effective services, community development, self-determination/local control, cultural continuity are present
Year 2
Individual Level Assessment: Alcohol Risk: Reflective Processes Resilience: Reflective Processes
Time Frame: Year 4
9-item measure of awareness of the reciprocal consequences of one's behavior across people and time, and focuses on reasons for sobriety through a culturally patterned type of awareness used in thinking over potential negative consequences of alcohol
Year 4
Individual Level Assessment: Youth: Community: Community Protective Factors
Time Frame: Year 4
Perceived support and opportunities in community
Year 4
Individual Level Assessment: Youth: Social Connection: Awareness of Connectedness
Time Frame: Year 4
Awareness of the interrelated welfare of the individual with family, community, and the natural environment
Year 4
Individual Level Assessment: Adult: Protective Community Factors: Protective Community Factors
Time Frame: Year 4
Community level organizational features of local control and cultural continuity
Year 4
Individual Level Assessment: Adult: Community Social Processes: Informal Social Control
Time Frame: Year 4
Question stem for generally held beliefs was, "People in this village believe that…" 6-items related to child welfare ("adults should know where their children are.", 10 items for child management ("adults should do something if a child is doing something dangerous"), 4-items related to adolescent behavior ("It is wrong for teenagers to fist fight."), 6-items related to crime ("People should do something if a neighbor's house is being vandalized.") and 5 items related to community member responsibility ("People should take action to make the village better.")
Year 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alaska Fairbanks

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Minnesota
University of Massachusetts, Amherst

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U19MH113138-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The Tribal Health Organizations and the research team jointly own all data, consistent with the principles of community-based participatory research (CBPR). De-identified data and results will be shared at every meeting of the AN External Advisory Council, Collaborative Hub and Research Steering Committee. Datasets are shared by request and approval by the Tribal Health Organizations and Project PIs as they become available. The research team propose to development Tribal Data Sharing and Ownership Agreements (DSOA) with the three participating Tribal Health Organizations in Year 1 of the ANCHRR project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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