NCT06128239

Brief Summary

Pragmatic randomized controlled trial to compare the effectiveness of two-way Caring Contacts text messages vs. one-way Caring Contacts text messages vs. enhanced usual care for suicide prevention in adults and adolescents.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
854

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 29, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

November 7, 2023

Last Update Submit

July 7, 2025

Conditions

Keywords

Caring Contactsbrief contact interventionadultadolescentprimary carebehavioral healthfollow-up care

Outcome Measures

Primary Outcomes (1)

  • Suicidal behavior

    Measured using the Harkavy-Asnis Suicide Scale (HASS) Active Suicidal Behavior Sub-Scale. The HASS has been validated for self-report, with strong psychometric properties in adolescents and adults. This measure asks about the frequency of suicide attempt planning, and actual and aborted/interrupted suicide attempts. Participants respond using the Likert scale response options used by Asarnow et al.'s validation study, modified to fit the survey time period (past six months at baseline/12-month outcome surveys, and past 3 months for 3- and 6-month outcome surveys). Each HASS sub-scale is scored separately by summing the response values. Scores on the Active Suicidal Behavior Sub-Scale range from 0 - 20, with higher scores corresponding to higher suicide risk. The primary outcome will be the cumulative risk of suicidal behavior assessed using area under the curve of the HASS scores over the 12-month study period.

    Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (4)

  • Suicide attempts

    Baseline, 3 months, 6 months, 12 months

  • Suicide ideation

    Baseline, 3 months, 6 months, 12 months

  • Suicide-related Emergency Department (ED) utilization and hospitalization

    Baseline, 3 months, 6 months, 12 months

  • Outpatient mental health treatment

    Baseline, 3 months, 6 months, 12 months

Other Outcomes (10)

  • Thwarted belongingness

    Baseline, 3 months, 6 months, 12 months

  • Perceived burdensomeness

    Baseline, 3 months, 6 months, 12 months

  • Suicidal ideation & behavior

    Baseline, 3 months, 6 months, 12 months

  • +7 more other outcomes

Study Arms (3)

Two-Way Caring Contacts Texts (CC2)

EXPERIMENTAL

In addition to receiving enhanced usual care as described below, a series of 25 standardized outgoing Caring Contacts text messages will be sent to participants randomized to the CC2 intervention arm through our online texting platform. To remind participants that they can respond, the outgoing texts will periodically invite replies in a non-demanding way, e.g., "Hope you're doing well this week, Anna. Feel free to text me back if you feel like it, I'm here for you." Responses to CC2 participant replies will be unscripted and individually tailored.

Behavioral: Caring Contacts

One-Way Caring Contacts Texts (CC1)

EXPERIMENTAL

In addition to receiving enhanced usual care as described below, CC1 participants will be sent 25 caring texts, such as "Even though know we do not personally know each other, we truly value your wellbeing and are thinking of you. If you'd like to connect with someone, feel free to call or text 988 anytime - their team would be happy to hear from you." CC1 participants will not be able to reply to the texts and the online texting platform will block incoming messages. This will be clearly communicated to CC1 participants during the informed consent process and they will be asked to sign off on understanding this and other key points before enrolling in the study.

Behavioral: Caring Contacts

Enhanced Usual Care (UC)

NO INTERVENTION

Participants randomized to the UC arm will receive best available usual care from the health system, such as standardized clinical assessments, the safety planning intervention or other intervention(s), appropriate referrals and/or medication management through a system wide electronic health record system-assisted suicide care clinical workflow. Usual care will vary based on patient clinical needs, availability of providers/staff, and provider clinical judgment. Following study enrollment, all participants will be given a list of resources, offered a warm hand-off to 988, and encouragement to call or text 988 as needed. During the baseline survey, participants will have the opportunity to opt into a call from the follow-up team to develop or revise a safety plan.

Interventions

Caring ContactsBEHAVIORAL

Text message version of Motto's Caring Contacts intervention. The study will compare two versions of text-based Caring Contacts: two-way messages, to which participants can respond to receive text-based support from follow-up specialists, and one-way text messages, to which participants cannot respond.

Also known as: Caring Texts, Caring Letters
One-Way Caring Contacts Texts (CC1)Two-Way Caring Contacts Texts (CC2)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adolescents (12-17 years old) and adults (18+)
  • Response of "yes" to at least one item on the Columbia Suicide Severity Rating Scale (C-SSRS) six-item screener at a St. Luke's Health System (SLHS) primary care or behavioral health clinic, or electronic health record or provider note from an eligible encounter indicates suicide risk
  • Ability to send and receive text messages
  • Ability to receive phone calls
  • Ability to receive emails
  • Participant and legal guardian (if applicable) speak, read, and understand English
  • Accommodations may be made for individuals with impaired hearing

You may not qualify if:

  • Individuals who participated in a previous randomized controlled trial in the same health system related to Caring Contacts (SPARC Trial or MHAPPS Trial)
  • Patients who are unable or unwilling to provide informed consent\*, for example, due to acute or chronic cognitive impairment (i.e.: acute psychosis, intoxication, or intellectual disability).
  • Primary Care Provider, Behavioral Health Provider, or Principal Investigator determines that participation in the research is not in the best interest of the patient or the study team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's Health System

Boise, Idaho, 83712, United States

Location

Related Publications (1)

  • Radin AK, Brown SP, Shaw J, Fouts T, McCue E, Skeie A, Pierce H, Flint H, Biss M, Sandoval D, Chase K, Davis J, Austin G, Chan KCG, Fruhbauerova M, Ratzliff A, Walton M, Bronner J, McCutchan PK, Comtois KA. Comparative effectiveness of two-way caring contacts texts vs one-way caring contacts texts vs enhanced usual care to reduce suicidal behavior in adolescents and adults: Protocol for the SPRING pragmatic randomized controlled trial. Contemp Clin Trials. 2025 Apr;151:107839. doi: 10.1016/j.cct.2025.107839. Epub 2025 Feb 10.

MeSH Terms

Conditions

SuicideSuicide PreventionSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Anna K Radin, DrPH, MPH

    St. Luke's Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants are aware of their own treatment condition but masked to the other two treatment conditions. Most investigators, including the senior statistician, are masked to treatment conditions.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants randomized 1:1:1 to three treatment conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Applied Research Scientist

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 13, 2023

Study Start

December 29, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

All data will be uploaded to the National Institutes for Mental Health Data Archive (NDA).

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be uploaded to NDA every 6 months during data collection, with complete data available \~7 months following the end of enrollment. Data will remain on NDA for as long as National Institute for Mental Health (NIMH) maintains the database.
Access Criteria
Publicly available
More information

Locations