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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02825771
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : April 6, 2021
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 years and older. This study will evaluate Caring Contacts, a low-cost, sustainable intervention for suicide prevention that sends caring 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 Messages 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, email, and postal mail. This study uses a randomized, controlled trial (RCT) to evaluate this approach to suicide prevention in 1,200 high-risk AI/ANs aged 18 and older 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.

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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 Contacts: A Strength-based, Suicide Prevention Trial in 4 Native Communities
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Usual Care + Caring Contacts messages
Usual care services plus caring contacts messages
Behavioral: Caring Contacts Messages
Text messages expressing care and support are sent following initial meeting on the following schedule: next day, 6 weekly, 9 bi-weekly, 7 monthly; one each on birthday, holiday, and seasonal (total of 25)

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 and 18 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 and 18 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 and 18 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 and 18 months ]
    Thwarted belongingness is one of two subscales on the INQ that measures the lack of perceived social connectedness

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 years or older
  3. self-identify as American Indian or Alaska Native
  4. are willing to be contacted periodically via text, email, or postal mail
  5. able to participate voluntarily
  6. speak and read English

Exclusion Criteria:

1) Cognitively unable and willing to independently provide written informed consent

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 identifier (NCT number): NCT02825771

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Contact: Lonnie A Nelson, PhD (206) 708-8623
Contact: Katherine Anne Comtois, PhD, MPH 206-897-4225

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United States, Montana
Fort Peck Tribes - Health Promotion / Disease Prevention Wellness Program Recruiting
Poplar, Montana, United States, 59255
Contact: Kenney Smoker, MBA         
Contact    406-768-3085      
United States, Oklahoma
Cherokee Nation Behavioral Health Recruiting
Tahlequah, Oklahoma, United States, 74464
Contact: Sam Bradshaw         
Contact    918-207-5538      
Sponsors and Collaborators
Washington State University
University of Washington
National Institute of Mental Health (NIMH)
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Principal Investigator: Lonnie A Nelson, PhD Washington State University
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Responsible Party: Lonnie Nelson, Assistant Professor, Washington State University Identifier: NCT02825771    
Other Study ID Numbers: UWashington
1R01MH106419-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Collaborative decision with four tribal partners.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms