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Active, Not Recruiting

NCT Number: NCT02825771

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington State University

Spokane, Washington, 99202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Cognitively unable and willing to independently provide written informed consent

Treatment and study plan

Caring Contacts Messages

Behavioral

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

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Washington

Registry information

Acronym: CARE

Important dates

Study start
2018
Primary completion
2023
Study completion
2025
First posted
Jul 7, 2016
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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