- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03131739
Alaska Native Collaborative Hub for Resilience Research (ANCHRR)
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
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Community Level Assessment: suicide and accidental deaths
Time Frame: Year 2
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The Trauma Registry and the Alaska Violent Death Reporting System (AKVDRS) will be used to document suicide and accidental deaths
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Year 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Individual Level Assessment: Youth: Individual: Communal Mastery Scale
Time Frame: Year 4
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Collective efficacy: solving life challenges through joining with others
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Year 4
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Individual Level Assessment: Youth: Family: Family Relationship Scale
Time Frame: Year 4
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Quality of family relationships
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Year 4
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Individual Level Assessment: Suicide Risk Resilience: Reasons for Life
Time Frame: Year 4
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Alaska Native cultural beliefs and experiences that make life enjoyable, worthwhile, and provide meaning
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Year 4
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Community Level Assessment: Community Protective Factors
Time Frame: Year 2
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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
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Year 2
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Individual Level Assessment: Alcohol Risk: Reflective Processes Resilience: Reflective Processes
Time Frame: Year 4
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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
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Year 4
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Individual Level Assessment: Youth: Community: Community Protective Factors
Time Frame: Year 4
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Perceived support and opportunities in community
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Year 4
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Individual Level Assessment: Youth: Social Connection: Awareness of Connectedness
Time Frame: Year 4
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Awareness of the interrelated welfare of the individual with family, community, and the natural environment
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Year 4
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Individual Level Assessment: Adult: Protective Community Factors: Protective Community Factors
Time Frame: Year 4
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Community level organizational features of local control and cultural continuity
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Year 4
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Individual Level Assessment: Adult: Community Social Processes: Informal Social Control
Time Frame: Year 4
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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.")
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Year 4
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U19MH113138-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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