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

Primary Purpose

Suicidal Ideation, Suicide, Attempted

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caring Contacts Messages
Usual Care
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Usual Care + Caring Contacts messages

Usual Care

Arm Description

Usual care services plus caring contacts messages

Usual care services provided in that community following identification of suicidal ideation or behavior.

Outcomes

Primary Outcome Measures

Suicidal Ideation Questionnaire (SIQ)
The SIQ comprises 15 items assessing frequency of suicidal thoughts in the past month
Suicide Attempt and Self-Injury Count (SASI-Count)
The SASI-Count interview assesses the method, intent, treatment received, and lethality for all suicide attempts in the follow-up time frame
Suicide-related hospitalizations
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

Interpersonal Needs Questionnaire (INQ) Thwarted Belongingness subscale
Thwarted belongingness is one of two subscales on the INQ that measures the lack of perceived social connectedness

Full Information

First Posted
July 3, 2016
Last Updated
April 24, 2023
Sponsor
Washington State University
Collaborators
University of Washington, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02825771
Brief Title
Caring Contacts: A Strength-based, Suicide Prevention Trial in 4 Native Communities
Acronym
CARE
Official Title
Caring Contacts: A Strength-based, Suicide Prevention Trial in 4 Native Communities
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington State University
Collaborators
University of Washington, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicide, Attempted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
711 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care + Caring Contacts messages
Arm Type
Experimental
Arm Description
Usual care services plus caring contacts messages
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care services provided in that community following identification of suicidal ideation or behavior.
Intervention Type
Behavioral
Intervention Name(s)
Caring Contacts Messages
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Usual care consists of services available to the participant in their community to reduce their suicide risk and improve their behavioral health
Primary Outcome Measure Information:
Title
Suicidal Ideation Questionnaire (SIQ)
Description
The SIQ comprises 15 items assessing frequency of suicidal thoughts in the past month
Time Frame
12 and 18 months
Title
Suicide Attempt and Self-Injury Count (SASI-Count)
Description
The SASI-Count interview assesses the method, intent, treatment received, and lethality for all suicide attempts in the follow-up time frame
Time Frame
12 and 18 months
Title
Suicide-related hospitalizations
Description
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
Time Frame
12 and 18 months
Secondary Outcome Measure Information:
Title
Interpersonal Needs Questionnaire (INQ) Thwarted Belongingness subscale
Description
Thwarted belongingness is one of two subscales on the INQ that measures the lack of perceived social connectedness
Time Frame
12 and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: be suicidal (Suicidal Ideation Questionnaire clinical cut-off score ≥ 32) or have a documented or self-reported suicide attempt within the past year be 18 years or older self-identify as American Indian or Alaska Native are willing to be contacted periodically via text, email, or postal mail able to participate voluntarily speak and read English Exclusion Criteria: 1) Cognitively unable and willing to independently provide written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lonnie A Nelson, PhD
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington State University
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Collaborative decision with four tribal partners.
Citations:
PubMed Identifier
36252937
Citation
Hebert LE, Fruhbauerova M, Evanson A, Bogic M, Petras A, Shaw J, Muller CJ, Nelson L, Comtois KA. Caring Texts, a strength-based, suicide prevention trial in 5 native communities: Research design and methods. Contemp Clin Trials. 2022 Dec;123:106966. doi: 10.1016/j.cct.2022.106966. Epub 2022 Oct 14.
Results Reference
derived

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

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