NCT02825771

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
711

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
1.9 years until next milestone

Study Start

First participant enrolled

May 30, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

5.4 years

First QC Date

July 3, 2016

Last Update Submit

July 26, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Interpersonal Needs Questionnaire (INQ) Thwarted Belongingness subscale

    12 and 18 months

Study Arms (2)

Usual Care + Caring Contacts messages

EXPERIMENTAL

Usual care services plus caring contacts messages

Behavioral: Caring Contacts MessagesBehavioral: Usual Care

Usual Care

ACTIVE COMPARATOR

Usual care services provided in that community following identification of suicidal ideation or behavior.

Behavioral: Usual Care

Interventions

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 + Caring Contacts messages
Usual CareBEHAVIORAL

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

Usual CareUsual Care + Caring Contacts messages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \) Cognitively unable and willing to independently provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Suicidal IdeationSuicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Lonnie A Nelson, PhD

    Washington State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 3, 2016

First Posted

July 7, 2016

Study Start

May 30, 2018

Primary Completion

October 31, 2023

Study Completion

October 31, 2025

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Collaborative decision with four tribal partners.

Locations