Clinical trial NCT02825771: Caring Contacts: A Strength-based, Suicide Prevention Trial in 4 Native Communities
Official title: Caring Contacts: A Strength-based, Suicide Prevention Trial in 4 Native Communities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicide, Attempted
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: National Institute of Mental Health (NIMH)
First posted: 2016-07-07
Enrollment: 711
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Suicidal Ideation Questionnaire (SIQ)
timeFrame: 12 and 18 months
measure: Suicide Attempt and Self-Injury Count (SASI-Count)
timeFrame: 12 and 18 months
measure: Suicide-related hospitalizations
timeFrame: 12 and 18 months
Secondary outcomes:
measure: Interpersonal Needs Questionnaire (INQ) Thwarted Belongingness subscale
timeFrame: 12 and 18 months
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: Washington State University
name: Lonnie A Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.