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

Sponsor
Washington State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02825771
Collaborator
University of Washington (Other), National Institute of Mental Health (NIMH) (NIH)
1,200
2
2
69.1
600
8.7

Study Details

Study Description

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
  • Behavioral: Caring Contacts Messages
  • Behavioral: Usual Care
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Suicidal Ideation Questionnaire (SIQ) [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) [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 [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 [12 and 18 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fort Peck Tribes - Health Promotion / Disease Prevention Wellness Program Poplar Montana United States 59255
2 Cherokee Nation Behavioral Health Tahlequah Oklahoma United States 74464

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lonnie Nelson, Assistant Professor, Washington State University
ClinicalTrials.gov Identifier:
NCT02825771
Other Study ID Numbers:
  • UWashington
  • 1R01MH106419-01A1
First Posted:
Jul 7, 2016
Last Update Posted:
Apr 6, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2021