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Clinical Trials/NCT05360888
NCT05360888RecruitingNot Applicable

Comparative Effectiveness of Two Culturally-Centered Suicide Interventions for Alaska Native Youth

RAND4 sites in 1 country300 target enrollmentStarted: December 22, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
RAND
Enrollment
300
Locations
4
Primary Endpoint
Anxiety

Study Overview

Brief Summary

Two interventions will be delivered virtually to American Indian/Alaska Native youth who have been hospitalized with suicidal attempt, suicidal ideation, or associated risk behaviors, including alcohol-related injury.

Detailed Description

The investigators will conduct a randomized controlled trial whereby Alaska Native (AN) youth who are hospitalized for suicide risk will be randomly assigned to either Qungasvik/Tools for Life or Tools for Life + Motivational Interviewing Social Network (MISN) intervention after their baseline survey, and followed up at 3-, 6-, and 12 months. All youth will receive Tools for Life and two 30-minute virtual follow-up visits (at 2- and 6-weeks post intervention) focused on connectivity to culture and obtaining support from intergenerational social networks in their home communities. Half of the youth will also receive MISN in addition to Tools for Life. Both interventions will be delivered virtually by a wellness team comprised of Alaska Native community behavioral health aides, prevention specialists and/or Elders who function in their communities as natural healers.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
14 Years to 24 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Self-identify as Alaska Native youth
  • Between the ages of 14 and 24
  • Admitted to the hospital for suicide attempt, ideation, or associated risk behaviors including alcohol-related injury or acute intoxication

Exclusion Criteria

  • Not provided

Arms & Interventions

Tools for Life

Active Comparator

All youth will receive the Tools for Life (Qungasvik) intervention. Tools for Life is an evidence-based, community-developed intervention focused on providing protective cultural experiences for Alaska Native youth to address suicide risk and alcohol use.

Intervention: Tools for Life (Behavioral)

Tools for Life + Motivational Interviewing Social Network intervention (MISN)

Active Comparator

Half of the youth will will also receive MISN in addition to the Tools for Life intervention. MISN is an evidence-based treatment that augments motivational interviewing with personal social network composition and structure visualization as a means to cultivating healthy social networks and cultural worlds.

Intervention: Tools for Life + MISN (Behavioral)

Outcomes

Primary Outcomes

Anxiety

Time Frame: Change from baseline to 12 months

Generalized Anxiety Disorder scale (GAD-7) \[0 -not at all to 3-nearly every day\]

Alcohol use consequences

Time Frame: Change from baseline to 12 months

Number of times in the past 3 months youth experience 4 different alcohol consequences \[0 = Never to 6 = 20 or more times\]

Frequency of alcohol use

Time Frame: Change from baseline to 12 months

Number of days used in the past 30 days \[ 0 to 30\]

Suicide intent/risk

Time Frame: Change from baseline to 12 months

We will use the Suicidal Ideation Attributes Scale (SIDAS) \[0 = Never, 10 = Always\]

Depression

Time Frame: Change from baseline to 12 months

Patient Health Questionnaire (PHQ-9) \[0 -not at all to 3-nearly every day\]

Secondary Outcomes

  • Intentions to be sober from alcohol(Change from baseline to 12 months)
  • Awareness of connectedness(Change from baseline to 12 months)
  • Individual protective factors(Change from baseline to 12 months)
  • Reasons for life(Change from baseline to 12 months)
  • Reflective processes(Change from baseline to 12 months)
  • Sobriety self-efficacy(Change from baseline to 12 months)
  • Time spent around peers who use alcohol(Change from baseline to 12 months)
  • Social network composition(Change from baseline to 12 months)
  • Social network structure(Change from baseline to 12 months)
  • Community protective factors(Change from baseline to 12 months)

Investigators

Sponsor
RAND
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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