- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03136094
Suicide in Urban Natives: Detection and Networks to Combat Events (SUNDANCE)
June 26, 2024 updated by: University of Colorado, Denver
Collaborative Hub to Reduce the Burden of Suicide Among Urban American Indian and Alaska Native Young Adults
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
698
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Erin Poole, MS
- Phone Number: (303) 724-0177
- Email: erin.poole@CUAnschutz.edu
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87108
- Recruiting
- First Nations Community HealthSource
-
Contact:
- Nichole Tsosie, MPH
- Phone Number: 505-262-2481
- Email: nichole.tsosie@fnch.org
-
Contact:
- Linda Son Stone, PhD
- Phone Number: 505-262-2481
- Email: linda.son-stone@fnch.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 34 years (Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Patients receive usual SBIRT care
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Suicidal Ideation
Time Frame: Baseline, 6 months, 12 months
|
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
Time Frame: Baseline, 6 months, 12 months
|
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
Time Frame: Baseline, 6 months, 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Social Connectedness
Time Frame: Baseline, 6 months, 12 months
|
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
|
|
SBIRT Retention and Uptake of Referral to Therapy
Time Frame: 6 months, 12 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Spero Manson, PhD, University of Colorado - Anschutz Medical Campus
- Principal Investigator: Dedra Buchwald, MD, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2020
Primary Completion (Estimated)
May 31, 2025
Study Completion (Estimated)
May 31, 2025
Study Registration Dates
First Submitted
April 27, 2017
First Submitted That Met QC Criteria
April 27, 2017
First Posted (Actual)
May 2, 2017
Study Record Updates
Last Update Posted (Actual)
June 27, 2024
Last Update Submitted That Met QC Criteria
June 26, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0186
- U19MH113135 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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