NCT05360888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

December 22, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

3.1 years

First QC Date

April 29, 2022

Last Update Submit

May 8, 2026

Conditions

Keywords

Alaska Native youth, suicide, prevention, culture

Outcome Measures

Primary Outcomes (15)

  • Suicide intent/risk

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

    Change from baseline to 3 months

  • Suicide intent/risk

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

    Change from baseline to 6 months

  • Suicide intent/risk

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

    Change from baseline to 12 months

  • Depression

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

    Change from baseline to 3 months

  • Depression

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

    Change from baseline to 6 months

  • Depression

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

    Change from baseline to 12 months

  • Anxiety

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

    Change from baseline to 3 months

  • Anxiety

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

    Change from baseline to 6 months

  • Anxiety

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

    Change from baseline to 12 months

  • Frequency of alcohol use

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

    Change from baseline to 3 months

  • Frequency of alcohol use

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

    Change from baseline to 6 months

  • Frequency of alcohol use

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

    Change from baseline to 12 months

  • Alcohol use consequences

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

    Change from baseline to 3 months

  • Alcohol use consequences

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

    Change from baseline to 6 months

  • Alcohol use consequences

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

    Change from baseline to 12 months

Secondary Outcomes (30)

  • Sobriety self-efficacy

    Change from baseline to 3 months

  • Sobriety self-efficacy

    Change from baseline to 6 months

  • Sobriety self-efficacy

    Change from baseline to 12 months

  • Intentions to be sober from alcohol

    Change from baseline to 3 months

  • Intentions to be sober from alcohol

    Change from baseline to 6 months

  • +25 more secondary outcomes

Study Arms (2)

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.

Behavioral: Tools for Life

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.

Behavioral: Tools for Life + MISN

Interventions

Tools for LifeBEHAVIORAL

Tools for Life focuses on empowering youth to learn more about their culture and their identity.

Tools for Life

Tools for Life focuses on empowering youth to learn more about their culture and their identity. MISN focuses on helping youth get support from their community and social networks.

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

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yukon-Kuskokwim Health Corporation

Bethel, Alaska, 99559, United States

Location

Tanana Chiefs Conference

Fairbanks, Alaska, 99559, United States

Location

Related Publications (2)

  • Rasmus S, D'Amico EJ, Allen J, Nation C, John S, Joseph V, Rodriguez A, Alvarado G, Gittens AD, Palimaru AI, Brown RA, Kennedy DP, Woodward MJ, Parker J, McDonald K. A protocol for a randomized controlled comparative effectiveness trial of two brief interventions focused on social and cultural connectedness to reduce risk for suicide and substance misuse in young Alaska Native people. BMC Public Health. 2025 Oct 15;25(1):3503. doi: 10.1186/s12889-025-24710-z.

  • Rasmus S, D'Amico EJ, Allen J, Nation C, John S, Joseph V, Rodriguez A, Alvarado G, Gittens AD, Palimaru AI, Brown RA, Kennedy DP, Woodward MJ, Parker J, McDonald K. Because We Love You (BeWeL): A protocol for a randomized controlled trial of two brief interventions focused on social and cultural connectedness to reduce risk for suicide and substance misuse in young Alaska Native people. Res Sq [Preprint]. 2024 Jan 22:rs.3.rs-3874293. doi: 10.21203/rs.3.rs-3874293/v1.

MeSH Terms

Conditions

Suicide, AttemptedSuicidal IdeationAlcoholic IntoxicationSuicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Half of the participants will be randomly assigned to Tools for Life, and the other half will receive Tools for Life plus a Motivational Interviewing Social Network intervention (MISN) and two booster sessions approximately 2 and 6 weeks post-intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 4, 2022

Study Start

December 22, 2022

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

The investigators will share only deidentified, aggregate data.

Locations