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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03136094
Other study ID # 18-0186
Secondary ID U19MH113135
Status Recruiting
Phase N/A
First received
Last updated
Start date March 15, 2020
Est. completion date May 31, 2024

Study information

Verified date April 2023
Source University of Colorado, Denver
Contact Erin Poole, MS
Phone (303) 724-0177
Email erin.poole@CUAnschutz.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The study, "Suicide in Urban Natives: Detection and Networks to Combat Events," builds on Screening, Brief Intervention and Referral to treatment (SBIRT), carried out through the primary care setting, to detect and manage suicide risk. This approach is multilevel, targeting both the healthcare system and the individual, and links screening to existing mobile phone technologies shown to promote resilience and to tap the protective benefits of social connectedness. This Collaborative Hub will conduct a randomized control trial that compares the effectiveness of enhancing these SBIRT programs by sending caring text messages to reduce suicidal ideation, attempts, and hospitalizations, and to increase engagement, social connectedness, and resilience. The Investigators' long-term goal is to disseminate and translate the lessons learned into practical policy, organizational changes, and preventive innovations that optimize patient-centered health outcomes and ultimately reduce or eliminate the dramatic and tragic suicide-related health disparities among urban AI/AN youth and young adults.


Recruitment information / eligibility

Status Recruiting
Enrollment 698
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 34 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
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

Locations

Country Name City State
United States First Nations Community HealthSource Albuquerque New Mexico

Sponsors (4)

Lead Sponsor Collaborator
University of Colorado, Denver National Institute of Mental Health (NIMH), University of New Mexico, Washington State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Change in Social Connectedness The investigators will assess social connectedness with the Interpersonal Needs Questionnaire, a validated measure of feelings of connectedness to others and of being a burden on others. Baseline, 6 months, 12 months
Secondary SBIRT Retention and Uptake of Referral to Therapy Retention will be measured as binary indicators of complete participation in the appropriate level of intervention determined during the initial in-person session with the behavioral therapist before enrollment in the study, and as uptake of therapy services for people who are referred to this level of care. For each participant, we will create a 3-category indicator of retention (full, partial, none). 6 months, 12 months
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