NCT03136094

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
698

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
2.9 years until next milestone

Study Start

First participant enrolled

March 15, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

5.2 years

First QC Date

April 27, 2017

Last Update Submit

June 26, 2024

Conditions

Keywords

American IndianAlaska NativeYouth and Young AdultSBIRT

Outcome Measures

Primary Outcomes (3)

  • Change in Suicidal Ideation

    The 15-item Suicidal Ideation Questionnaire Jr. assesses frequency of suicidal thoughts in the past month. Item content ranges from general thoughts of death and wishes that one were dead to specific thoughts of self-injurious behavior. Responses are on a 7-point scale ranging from never to almost daily. Items are summed for a total score (range 0-90).

    Baseline, 6 months, 12 months

  • Change in Self-Reported Suicide Attempts

    The investigators will use the interviewer-administered Suicide Attempt and Self-Injury Count to assess the method, intent, treatment received, and lethality for all suicide attempts over the respondent's lifetime.

    Baseline, 6 months, 12 months

  • Change in Hospitalizations and Behavioral Health Treatment

    The investigators will assess self-reported hospitalizations over the previous 12 months with a measure of health service use previously applied to AI/ANs. It captures information on inpatient and outpatient medical care, emergency room visits, and use of traditional practices.

    Baseline, 6 months, 12 months

Secondary Outcomes (2)

  • Change in Social Connectedness

    Baseline, 6 months, 12 months

  • SBIRT Retention and Uptake of Referral to Therapy

    6 months, 12 months

Study Arms (2)

SBIRT+Usual Care

PLACEBO COMPARATOR

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

Behavioral: SBIRT+Usual Care

SBIRT+12

EXPERIMENTAL

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.

Behavioral: SBIRT+12

Interventions

SBIRT+12BEHAVIORAL

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+12

Patients receive usual SBIRT care

SBIRT+Usual Care

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Nations Community HealthSource

Albuquerque, New Mexico, 87108, United States

RECRUITING

Related Publications (5)

  • Herne MA, Bartholomew ML, Weahkee RL. Suicide mortality among American Indians and Alaska Natives, 1999-2009. Am J Public Health. 2014 Jun;104 Suppl 3(Suppl 3):S336-42. doi: 10.2105/AJPH.2014.301929. Epub 2014 Apr 22.

    PMID: 24754665BACKGROUND
  • Mann JJ, Apter A, Bertolote J, Beautrais A, Currier D, Haas A, Hegerl U, Lonnqvist J, Malone K, Marusic A, Mehlum L, Patton G, Phillips M, Rutz W, Rihmer Z, Schmidtke A, Shaffer D, Silverman M, Takahashi Y, Varnik A, Wasserman D, Yip P, Hendin H. Suicide prevention strategies: a systematic review. JAMA. 2005 Oct 26;294(16):2064-74. doi: 10.1001/jama.294.16.2064.

    PMID: 16249421BACKGROUND
  • Luoma JB, Martin CE, Pearson JL. Contact with mental health and primary care providers before suicide: a review of the evidence. Am J Psychiatry. 2002 Jun;159(6):909-16. doi: 10.1176/appi.ajp.159.6.909.

    PMID: 12042175BACKGROUND
  • Beals J, Novins DK, Whitesell NR, Spicer P, Mitchell CM, Manson SM. Prevalence of mental disorders and utilization of mental health services in two American Indian reservation populations: mental health disparities in a national context. Am J Psychiatry. 2005 Sep;162(9):1723-32. doi: 10.1176/appi.ajp.162.9.1723.

    PMID: 16135633BACKGROUND
  • Morgan ER, Bogic M, Hebert L, Poole E, Tsosie N, Tsosie N, Garcia K, O'Leary M, Mettler R, Johnson G, Son-Stone L, Parker T, Buchwald D, Manson S. Caring Text Messages for Suicide Prevention in Urban American Indian Youth: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 26;14:e71344. doi: 10.2196/71344.

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Spero Manson, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
  • Dedra Buchwald, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patients will not be given details about how text messaging differs for the 2 study groups. Instead, patients will be told that the clinic is testing a program to support people who are having hard times, and that they will receive periodic text messages from the Site Coordinator for the next 12 months.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The Investigators will conduct a randomized controlled trial to test the effectiveness of an augmented Screening, Brief Intervention, and Referral to Treatment (SBIRT) model that includes sending caring text messages for 12 months after an at-risk patient is identified.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 2, 2017

Study Start

March 15, 2020

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations