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

• ClinicalTrials.gov Identifier: NCT02825771
• Recruitment Status: Active, not recruiting
• First Posted: July 7, 2016
• Last Update Posted: April 26, 2023
• Sponsor: Washington State University
• Collaborators: University of Washington; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Lonnie Nelson, Washington State University

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
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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 711 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 2024
• Estimated Study Completion Date: March 2025

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) [ 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older 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 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

United States, Washington

Washington State University

Spokane, Washington, United States, 99202

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Lonnie Nelson, Associate Professor, Washington State University
• ClinicalTrials.gov Identifier: NCT02825771
• Other Study ID Numbers: UWashington; 1R01MH106419-01A1 ( U.S. NIH Grant/Contract )
• First Posted: July 7, 2016
• Last Update Posted: April 26, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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 Prevention; Suicide, Attempted; Self-Injurious Behavior; Behavioral Symptoms