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

Suicidal Ideation Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02825771
• Other study ID #: UWashington
• Secondary ID: 1R01MH106419-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 711
• Est. completion date: March 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

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)
• Usual Care
Usual care consists of services available to the participant in their community to reduce their suicide risk and improve their behavioral health

Locations

Country	Name	City	State
United States	Washington State University	Spokane	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Washington State University	National Institute of Mental Health (NIMH), University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicidal Ideation Questionnaire (SIQ)	The SIQ comprises 15 items assessing frequency of suicidal thoughts in the past month	12 and 18 months
Primary	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
Primary	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	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