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Suicide Prevention for Urban Native Kids and Youth (SPUNKY)

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ClinicalTrials.gov Identifier: NCT03136094
Recruitment Status : Not yet recruiting
First Posted : May 2, 2017
Last Update Posted : June 9, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Suicide Prevention Behavioral: SBIRT Usual Care Behavioral: SBIRT+6 Behavioral: SBIRT+12

Detailed Description:
The study, "Suicide Prevention for Urban Native Kids and Youth (SPUNKY)," builds on Screening, Brief Intervention and Referral toTreatment (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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The Investigators will conduct a randomized-control trial to test the effectiveness of an augmented Screening, Brief Intervention, and Referral to Treatment (SBIRT) model that includes sending caring text messages for 6 or 12 months after an at-risk patient is identified.
Masking: Single (Participant)
Masking Description: Patients will not be given details about how text messaging differs for the 3 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.
Primary Purpose: Prevention
Official Title: Collaborative Hub to Reduce the Burden of Suicide Among Urban American Indian and Alaska Native Youth
Anticipated Study Start Date : January 30, 2018
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
U.S. FDA Resources

Arms and Interventions

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
Behavioral: SBIRT Usual Care
Participants in this arm will receive the usual standard of care: Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Experimental: SBIRT+6
The standard SBIRT model is augmented by a 6 month period during which participants received caring text messages
Behavioral: SBIRT Usual Care
Participants in this arm will receive the usual standard of care: Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Behavioral: SBIRT+6
In addition to SBIRT, participants in this experimental arm will receive text messages adapted from empirically-based, effective interventions for suicide prevention among American Indian and Alaska Native youth and young adults for 6-months following identification of suicide risk.
Experimental: SBIRT+12
The standard SBIRT model is augmented by a 12 month period during which participants received caring text messages
Behavioral: SBIRT Usual Care
Participants in this arm will receive the usual standard of care: Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Behavioral: SBIRT+12
In addition to SBIRT, participants in this experimental arm will receive text messages adapted from empirically-based, effective interventions for suicide prevention among American Indian and Alaska Native youth and young adults for 12-months following identification of suicide risk.


Outcome Measures

Primary Outcome Measures :
  1. 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).

  2. Change in Self-Reported Suicide Attempts [ Time Frame: Baseline, 6 months, 12 months ]
    We 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.

  3. Change in Hospitalizations and Behavioral Health Treatment [ Time Frame: Baseline, 6 months, 12 months ]
    We 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 :
  1. Change in Social Connectedness [ Time Frame: Baseline, 6 months, 12 months ]
    We 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.

  2. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 34 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Self-identified as American Indian or Alaska Native; screen positive for mild, moderate, or severe risk of suicidality; successfully complete the brief intervention component of SBIRT; 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 or assent or if age 12-17 have a parent or guardian present who is willing to participate in the informed consent process.

Exclusion Criteria: In danger of imminent self-harm; hospitalized

Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Tassy Parker, PhD, RN (505) 925-7471 TaParker@salud.unm.edu
Contact: Annette Squetimkin Anquoe, PhD (206) 324-9360 ext 2111 annettes@sihb.org

Sponsors and Collaborators
University of Colorado, Denver
Washington State University
University of New Mexico
Investigators
Principal Investigator: Spero Manson, PhD University of Colorado - Anschutz Medical Campus
Principal Investigator: Dedra Buchwald, MD University of Washington
More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03136094     History of Changes
Other Study ID Numbers: 17-0839
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
American Indian
Alaska Native
Youth and Young Adult
SBIRT

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms