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Caring Texts: A Strength-based, Suicide Prevention Trial in 4 Native Communities (CARE)

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ClinicalTrials.gov Identifier: NCT02825771
Recruitment Status : Not yet recruiting
First Posted : July 7, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
University of Washington
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Lonnie Nelson, Washington State University

Brief Summary:
Suicide is the second leading cause of death for American Indians and Alaska Natives aged 18-34 years. This study will evaluate Caring Contacts, a low-cost, sustainable intervention for suicide prevention that sends caring text messages to people at risk. The investigators will implement the intervention at four tribal sites, leveraging community strengths and values to address this tragic health disparity in an underserved minority population.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Suicide, Attempted Behavioral: Caring Contacts via Text Message Behavioral: Usual Care Not Applicable

Detailed Description:
High rates of suicide are endemic in American Indian and Alaska Native (AI/AN) young adults. A recent study found that rates for young AI/AN adults in the Northern Plains and in Alaska are more than 4 times higher than for Whites of the same age in the same regions. Building social connections is a key goal of suicide prevention. One validated theoretical model asserts that belonging to a group is a fundamental human need. When this need is thwarted by social isolation or inadequate social support, a desire for death emerges. Studies of suicide prevention in AI/ANs underscore the cultural importance of connection to friends, family, caring neighbors, and community leaders. These traditions of community cohesion can be leveraged to protect young AI/AN adults against suicidal ideation and behavior. Caring Contacts is a suicide prevention program that supplements standard care by promoting human connectedness. People at risk for suicide often lose contact with the healthcare system and receive no follow-up care. For one year after initial contact, Caring Contacts seeks out such individuals to send messages expressing care, concern, and interest. It is the only intervention shown to prevent suicide in any population in a randomized, controlled trial. Based on a two year collaborative process with four tribal partners as part of a pilot grant, this study will evaluate a locally feasible, culturally appropriate Caring Contacts intervention that will use text messaging, the dominant communication method for young AI/AN adults. This study uses a randomized, controlled trial (RCT) to evaluate this approach to suicide prevention in 1,200 high-risk AI/ANs aged 18-34 from our four partner communities. Specific Aims are to: 1) Compare the effectiveness of usual care (control) to the control condition plus caring text messages (intervention) for reducing suicidal ideation, suicide attempts, and suicide related hospitalizations. 2) Evaluate social connectedness as a mediating factor for the effect of Caring Contacts via text message on suicidality. The US Surgeon General's National Strategy for Suicide Prevention identifies connectedness to others as a primary protective factor against suicidality. By adapting and disseminating the Caring Contacts approach, which has demonstrated effectiveness in non-Native populations, this study will evaluate a low-cost, sustainable intervention for addressing the profound disparity of suicide risk experienced by young adult AI/ANs.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Caring Texts: A Strength-based, Suicide Prevention Trial in 4 Native Communities
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Usual Care + Caring Contacts via Text
Usual care services plus caring contacts via text message
Behavioral: Caring Contacts via Text Message
Text messages expressing care and support are sent following initial meeting on the following schedule: one day, one week, months 1, 2, 3, 4, 6, 8, 10, 12 plus the participants' birthday. (This schedule may change as a result of cultural adaptation in Year 1)

Behavioral: Usual Care
Usual care consists of services available to the participant in their community to reduce their suicide risk and improve their behavioral health

Active Comparator: Usual Care
Usual care services provided in that community following identification of suicidal ideation or behavior.
Behavioral: Usual Care
Usual care consists of services available to the participant in their community to reduce their suicide risk and improve their behavioral health




Primary Outcome Measures :
  1. Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 12 months ]
    The SIQ comprises 15 items assessing frequency of suicidal thoughts in the past month

  2. Suicide Attempt and Self-Injury Count (SASI-Count) [ Time Frame: 12 months ]
    The SASI-Count interview assesses the method, intent, treatment received, and lethality for all suicide attempts in the follow-up time frame

  3. Suicide-related hospitalizations [ Time Frame: 12 months ]
    Hospitalizations will be assessed using the American Indian Services Utilization and Psychiatric Epidemiology Risk and Protective Factors Project (AI-SUPERPFP) measure of service utilization which captures all admissions to inpatient medical and psychiatric care as well as emergency room visits


Secondary Outcome Measures :
  1. Interpersonal Needs Questionnaire (INQ) Thwarted Belongingness subscale [ Time Frame: 12 months ]
    Thwarted belongingness is one of two subscales on the INQ that measures the lack of perceived social connectedness



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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. be suicidal (Suicidal Ideation Questionnaire clinical cut-off score ≥ 32) or have a documented or self-reported suicide attempt within the past year
  2. be 18-34 years old
  3. self-identify as American Indian or Alaska Native
  4. have a text-enabled cell phone
  5. be willing to be contacted by text
  6. able to participate voluntarily
  7. speak and read English
  8. be cognitively able and willing to independently provide written informed consent

Exclusion Criteria:

  1. Clinical contraindication to participation (e.g., paranoia about being contacted by clinicians

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): NCT02825771


Contacts
Contact: Lonnie A Nelson, PhD (206) 708-8623 lonnie.nelson@wsu.edu
Contact: Katherine Anne Comtois, PhD, MPH 206-897-4225 katespnc@uw.edu

Sponsors and Collaborators
Washington State University
University of Washington
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Lonnie A Nelson, PhD Washington State University

Responsible Party: Lonnie Nelson, Assistant Professor, Washington State University
ClinicalTrials.gov Identifier: NCT02825771     History of Changes
Other Study ID Numbers: UWashington
1R01MH106419-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Collaborative decision with four tribal partners.

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

Additional relevant MeSH terms:
Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms