Suicide in Urban Natives: Detection and Networks to Combat Events (SUNDANCE)
Primary Purpose
Suicide Prevention
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SBIRT+12
SBIRT+Usual Care
Sponsored by
About this trial
This is an interventional prevention trial for Suicide Prevention focused on measuring American Indian, Alaska Native, Youth and Young Adult, SBIRT
Eligibility Criteria
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
Sites / Locations
- First Nations Community HealthSourceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
SBIRT+Usual Care
SBIRT+12
Arm Description
The control arm of the trial will receive the usual care prescribed in the Screening, Brief Intervention and Referral to Treatment (SBIRT) model.
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.
Outcomes
Primary Outcome Measures
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).
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.
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.
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT03136094
First Posted
April 27, 2017
Last Updated
April 21, 2023
Sponsor
University of Colorado, Denver
Collaborators
Washington State University, University of New Mexico, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03136094
Brief Title
Suicide in Urban Natives: Detection and Networks to Combat Events
Acronym
SUNDANCE
Official Title
Collaborative Hub to Reduce the Burden of Suicide Among Urban American Indian and Alaska Native Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Washington State University, University of New Mexico, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Prevention
Keywords
American Indian, Alaska Native, Youth and Young Adult, SBIRT
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
698 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SBIRT+Usual Care
Arm Type
Placebo Comparator
Arm Description
The control arm of the trial will receive the usual care prescribed in the Screening, Brief Intervention and Referral to Treatment (SBIRT) model.
Arm Title
SBIRT+12
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SBIRT+12
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SBIRT+Usual Care
Intervention Description
Patients receive usual SBIRT care
Primary Outcome Measure Information:
Title
Change in Suicidal Ideation
Description
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).
Time Frame
Baseline, 6 months, 12 months
Title
Change in Self-Reported Suicide Attempts
Description
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.
Time Frame
Baseline, 6 months, 12 months
Title
Change in Hospitalizations and Behavioral Health Treatment
Description
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.
Time Frame
Baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change in Social Connectedness
Description
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.
Time Frame
Baseline, 6 months, 12 months
Title
SBIRT Retention and Uptake of Referral to Therapy
Description
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).
Time Frame
6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Poole, MS
Phone
(303) 724-0177
Email
erin.poole@CUAnschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spero Manson, PhD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dedra Buchwald, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Nations Community HealthSource
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nichole Tsosie, MPH
Phone
505-262-2481
Email
nichole.tsosie@fnch.org
First Name & Middle Initial & Last Name & Degree
Linda Son Stone, PhD
Phone
505-262-2481
Email
linda.son-stone@fnch.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24754665
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.
Results Reference
background
PubMed Identifier
16249421
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.
Results Reference
background
PubMed Identifier
12042175
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.
Results Reference
background
PubMed Identifier
16135633
Citation
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.
Results Reference
background
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Suicide in Urban Natives: Detection and Networks to Combat Events
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