Suicide PreventionSUNDANCENCT03136094
Suicide in Urban Natives: Detection and Networks to Combat Events
A study testing SBIRT+12 in people with Suicide Prevention, run by University of Colorado, Denver at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- SBIRT+12
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 698 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2020to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Under age 18
- In danger of imminent self-harm;
- Hospitalized
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
First Nations Community HealthSource
Albuquerque, New Mexico, 87108
Nichole Tsosie, MPH, 505-262-2481, nichole.tsosie@fnch.org
Linda Son Stone, PhD, 505-262-2481, linda.son-stone@fnch.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide Prevention
- Being tested
- SBIRT+12, SBIRT+Usual Care
- Keywords
- American Indian, Alaska Native, Youth and Young Adult, SBIRT
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBIRT+12Behavioural
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 CareBehavioural
Patients receive usual SBIRT care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: SBIRT+12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (2)
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.
Measured: Baseline, 6 months, 12 months
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).
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start15 Mar 2020
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 698 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State University, University of New Mexico, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Spero Manson, PhD, Principal investigator, University of Colorado, DenverDedra Buchwald, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136094
- Sponsor's protocol ID
- 18-0186
- Other IDs
- U19MH113135
- Acronym
- SUNDANCE
- Status last verified
- Jun 2024
- First submitted
- 27 Apr 2017
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24754665Mann 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.
PubMed 16249421Luoma 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.
PubMed 12042175Beals 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.
PubMed 16135633Morgan 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.
PubMed 41004795
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Hub to Reduce the Burden of Suicide Among Urban American Indian and Alaska Native Young Adults
- ClinicalTrials.gov ID
- NCT03136094
- Acronym / sponsor ID
- SUNDANCE / 18-0186
- Conditions
- Suicide Prevention
- Keywords
- American Indian, Alaska Native, Youth and Young Adult, SBIRT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 698 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Washington State University, University of New Mexico, National Institute of Mental Health (NIMH)
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SBIRT+Usual Care | Placebo comparator | Behavioral: SBIRT+Usual CareThe control arm of the trial will receive the usual care prescribed in the Screening, Brief Intervention and Referral to Treatment (SBIRT) model. |
| SBIRT+12 | Experimental | Behavioral: SBIRT+12The 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. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- Under age 18
- In danger of imminent self-harm;
- Hospitalized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBIRT+12The 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. | Behavioural | SBIRT+12 |
| SBIRT+Usual CarePatients receive usual SBIRT care | Behavioural | SBIRT+Usual Care |
Primary outcome
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).
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.
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.
2 secondary outcomes
Change in Social Connectedness
Time frame: Baseline, 6 months, 12 months
SBIRT Retention and Uptake of Referral to Therapy
Time frame: 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 24754665Herne 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.
- Background: PubMed 16249421Mann 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.
- Background: PubMed 12042175Luoma 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.
- Background: PubMed 16135633Beals 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.
- Derived from this study: PubMed 41004795Morgan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spero Manson, PhD principal investigator
University of Colorado, Denver
Dedra Buchwald, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBIRT+12 in people with Suicide Prevention, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin Poole, MS ((303) 724-0177, erin.poole@CUAnschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Suicidal Ideation (time frame: Baseline, 6 months, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136094, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.