Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT03136094

Conditions

Suicide Prevention

Eligibility Criteria

Sex: All

Age: 18 - 34

Healthy Volunteers: Not accepted

Interventions

SBIRT+12

SBIRT+Usual Care

Study Details

Brief summary:

This study compares the effectiveness of a program to detect and manage suicide risk among American-Indian and Alaska Native (AI/AN) youth. Half of the participants will receive caring text messages to reduce suicidal thoughts, attempts, and hospitalizations and to increase engagement, social connectedness, and resilience in at-risk youth. The other half will receive usual care that does not include the caring text messages.

Conditions

Suicide Prevention

Study ID

NCT03136094

Start date

Mar 15, 2020

Status verified date

Jun, 2024

Completion date

May 31, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 34

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Self-identify as American Indian or Alaska Native;
  • Screen positive for mild, moderate, or severe risk of suicidality (referred by a clinical provider);
  • Have a text-enabled mobile phone;
  • Willing to be contacted by text;
  • Able to participate voluntarily;
  • Speak and read English;
  • Cognitively able to independently provide written informed consent

Exclusion Criteria:

  • Under age 18
  • In danger of imminent self-harm;
  • Hospitalized

Study Design

Enrollment

698 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: SBIRT+Usual Care

The control arm of the trial will receive the usual care prescribed in the Screening, Brief Intervention and Referral to Treatment (SBIRT) model.

experimental: SBIRT+12

The standard SBIRT model is augmented by a 12 month period following identification of suicide risk during which participants will receive caring text messages adapted from empirically-based, effective interventions for suicide prevention among American Indian and Alaska Native young adults.

Interventions

SBIRT+12

The standard SBIRT model is augmented by a 12 month period following identification of suicide risk during which participants received caring text messages adapted from empirically-based, effective interventions for suicide prevention among American Indian and Alaska Native young adults.

SBIRT+Usual Care

Patients receive usual SBIRT care

Primary outcome measure

  • Change in Suicidal Ideation [ Time Frame: Baseline, 6 months, 12 months ]
  • Change in Self-Reported Suicide Attempts [ Time Frame: Baseline, 6 months, 12 months ]
  • Change in Hospitalizations and Behavioral Health Treatment [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts and Locations

Central contacts

Erin Poole, MS

(303) 724-0177erin.poole@CUAnschutz.edu

Locations

First Nations Community HealthSource

Recruiting

Albuquerque, New Mexico, United States, 87108

Contacts

Nichole Tsosie, MPH

505-262-2481nichole.tsosie@fnch.org

Linda Son Stone, PhD

505-262-2481linda.son-stone@fnch.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 27, 2024

Last verified

Jun, 2024

Keywords

  • American Indian
  • Alaska Native
  • Youth and Young Adult
  • SBIRT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-06-27.