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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Suicidal Ideation; Suicide, Attempted
• Intervention / Treatment: Behavioral: Caring Contacts Messages; Behavioral: Usual Care

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 Type: Interventional
• Enrollment (Actual): 711
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99202
      • Washington State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicidal Ideation Questionnaire (SIQ)	The SIQ comprises 15 items assessing frequency of suicidal thoughts in the past month	12 and 18 months
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	12 and 18 months
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	12 and 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 and 18 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: July 3, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: UWashington; 1R01MH106419-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Collaborative decision with four tribal partners.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No