Suicide in Urban Natives: Detection and Networks to Combat Events (SUNDANCE)
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|ClinicalTrials.gov Identifier: NCT03136094|
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : April 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Suicide Prevention||Behavioral: SBIRT+12 Behavioral: SBIRT+Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||698 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Outcomes 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.|
|Official Title:||Collaborative Hub to Reduce the Burden of Suicide Among Urban American Indian and Alaska Native Young Adults|
|Actual Study Start Date :||March 15, 2020|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||May 31, 2024|
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.
Behavioral: SBIRT+Usual Care
Patients receive usual SBIRT care
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.
- 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.
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136094
|Contact: Erin Poole, MS||(303) 724-0177||erin.poole@CUAnschutz.edu|
|Principal Investigator:||Spero Manson, PhD||University of Colorado - Anschutz Medical Campus|
|Principal Investigator:||Dedra Buchwald, MD||University of Washington|