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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06128239
Other study ID # 2023-0088
Secondary ID TBT-0-022-22
Status Recruiting
Phase N/A
First received
Last updated
Start date December 29, 2023
Est. completion date December 28, 2026

Study information

Verified date December 2023
Source St. Luke's Health System, Boise, Idaho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 849
Est. completion date December 28, 2026
Est. primary completion date December 28, 2026
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Intervention

Behavioral:
Caring Contacts
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.

Locations

Country Name City State
United States St. Luke's Health System Boise Idaho

Sponsors (4)

Lead Sponsor Collaborator
St. Luke's Health System, Boise, Idaho American Foundation for Suicide Prevention, Idaho Crisis & Suicide Hotline, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Thwarted belongingness Thwarted belongingness will be measured using the 15-item version of the Interpersonal Needs Questionnaire.
The 15-item version of the Interpersonal Needs Questionnaire (INQ15) is a validated tool to measure both perceived burdensomeness (PB) (6 items, scores range from 6 to 42) and thwarted belongingness (TB) (9 items; scores range from 9 to 63), which are related to desire for suicide. Individuals provide a self-report response to each of 15 items using a Likert scale ranging from 1 (Not at all true for me) to 7 (Very true for me). The appropriate items are reverse coded, and items are summed to calculate the TB and PB subscale scores with higher scores indicating greater TB and PB. Clinical Cutoff scores predicting desire for death are 35 or greater for TB and 19 or greater for PB. Clinical cutoff scores predicting desire for suicide are 50 or greater for TB and 30 or greater for PB.
Baseline, 3 months, 6 months, 12 months
Other Perceived burdensomeness Perceived burdensomeness will be measured using the 15-item version of the Interpersonal Needs Questionnaire.
The 15-item version of the Interpersonal Needs Questionnaire (INQ15) is a validated tool to measure both perceived burdensomeness (PB) (6 items, scores range from 6 to 42) and thwarted belongingness (TB) (9 items; scores range from 9 to 63), which are related to desire for suicide. Individuals provide a self-report response to each of 15 items using a Likert scale ranging from 1 (Not at all true for me) to 7 (Very true for me). The appropriate items are reverse coded, and items are summed to calculate the TB and PB subscale scores with higher scores indicating greater TB and PB. Clinical Cutoff scores predicting desire for death are 35 or greater for TB and 19 or greater for PB. Clinical cutoff scores predicting desire for suicide are 50 or greater for TB and 30 or greater for PB.
Baseline, 3 months, 6 months, 12 months
Other Suicidal ideation & behavior A combined indicator of suicidal ideation and behavior will be assessed using the Columbia Suicide Severity Rating Scale self-report 6-item screener for primary care (C-SSRS) plus several additional items from the full Columbia Suicide Severity Rating Scale (interview) (interrupted suicide attempts, self-aborted suicide attempts, actual suicide attempts, and suicide deaths). Scores range from 0 (no suicide risk indicated) to 10 (death by suicide), with higher scores indicating higher suicide risk. Baseline, 3 months, 6 months, 12 months
Other Suicide attempts (including actual, aborted, or interrupted attempts) The frequency of suicide attempts (including actual attempts, interrupted attempts, and self-aborted attempts) will be measured using the two-item Suicide Attempts Sub-Scale of the Harkavy-Asnis Suicide Scale (HASS). Scores on the Suicide Attempts Sub-Scale range from 0 - 8, with higher scores corresponding to higher suicide risk. Baseline, 3 months, 6 months, 12 months
Other Perceived mattering to others The General Mattering Scale (GMS) will be used to assess the extent to which participants believe they matter to other people. Participants use a Likert scale from 1-4 to respond to each of five items. Scoring is completed by summing the responses, with results ranging from 5 to 20 and higher scores corresponding to higher levels of perceived mattering to others (better outcomes). Baseline, 3 months, 6 months, 12 months
Other Non-suicidal self-injury Non-suicidal self-injury will be measured with select items from the Self-Injurious Thoughts and Behavior Interview - Revised (SITBI-R). Each item is assessed individually, and items are not scored together in a scale. Baseline, 3 months, 6 months, 12 months
Other All-cause ED utilization and hospitalizations The number of and reason for visit/diagnoses for ED encounters and hospitalizations will be assessed using electronic medical records. Baseline, 3 months, 6 months, 12 months
Other Completed suicide The manner and cause/lethal means of all deaths including death by suicide will be assessed based on electronic medical records and vital records Baseline, 3 months, 6 months, 12 months
Other All-cause mortality The manner and cause/lethal means of all deaths including death by suicide will be assessed based on electronic medical records and vital records Baseline, 3 months, 6 months, 12 months
Primary 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 Suicide attempts A count of suicide attempts will be measured using the Self-Injurious Thoughts and Behavior Interview - Revised (SITBI-R), which is valid for self-report in adolescents and adults. Baseline, 3 months, 6 months, 12 months
Secondary Suicide ideation Suicidal ideation will be measured using the Passive Suicidal Ideation Subscale of the Harkavy-Asnis Suicide Scale (HASS), which includes 12 items. Scores on the Passive Suicidal Ideation Sub-Scale range from 0 - 48, with higher scores corresponding to higher suicide risk. Baseline, 3 months, 6 months, 12 months
Secondary Suicide-related Emergency Department (ED) utilization and hospitalization Suicide-related ED utilization and hospitalization will be assessed by self-report and using electronic medical records. Reason for visit/diagnoses may be reviewed in electronic medical records for any inpatient or outpatient encounters that occur during the study period. Baseline, 3 months, 6 months, 12 months
Secondary Outpatient mental health treatment Outpatient mental health treatment will be self-reported and assessed using electronic medical records. Reason for visit/diagnoses may be reviewed in electronic medical records for any inpatient or outpatient encounters that occur during the study period. Baseline, 3 months, 6 months, 12 months
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