Caring Connections Youth Suicide Detection and Intervention Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13+
SponsorUniversity of North Carolina, Chapel Hill
About this trial
The goal of this pilot randomized control trial (RCT) is to test the feasibility of Caring Connections, a Culturally Adapted Linking Individuals Needing Care (CA-LINC) suicide prevention care coordination intervention for high-risk suicidal youth. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement. Connections is a 90-day intervention that integrates engagement and follow-up strategies to assess/monitor suicide risk, facilitate service use referrals/linkages, develop/refine safety plans, and create villages of care. The intervention incorporates cultural promotive factors, empowerment, and motivational strategies aimed at supporting youth, enhancing strengths, promoting hope, improving family relationships, and reinforcing caring messages. Primary research questions include:
Is Caring Connections feasible to use for suicidal high-risk youth? Does Caring Connections have the potential to reduce suicide ideation and behaviors among high-risk suicidal youth?
For the pilot RCT, 80 youth participants ages 13-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: Caring Connections (n=40) or Treatment as Usual (n=40). Additionally, investigators will enroll 80 caregivers of youth meeting inclusion criteria and 20 Mental Healthcare, Healthcare Providers, Community Stakeholders, and/or Care Coordinators with experience working with suicidal youth. Researchers will compare those receiving Caring Connections with treatment as usual to see if suicidal ideation and behaviors, and engagement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
13 - 19 years old
Current or recent history (<90 days) of suicide ideation, planning, or attempts or nonsuicidal self-injurious behaviors per youth or caregiver self-report or positive screen on the Patient Health Questionnaire Adolescent (PHQ-A), C-SSRS, or Ask Suicide-Screening Questions (ASQ).
Able to fluently speak and read English
Youth with a prior history of difficulty accessing services.
Disqualifiers
Youth at imminent suicide risk (reported verbally and/or indicated on C-SSRS)
Youth who exhibit severe cognitive, language, or developmental delays
Youth not meeting inclusion criteria
Not meeting the inclusion criteria listed above.
Trial design
Design model
Parallel
Treatments tested in this trial
Caring Connections
BehavioralParticipants received the Caring Connections Intervention.
Treatment as Usual
BehavioralParticipants received Treatment as Usual
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Caring ConnectionsExperimental treatment 1 intervention
Group B: Treatment as UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in suicidal ideation
The Suicide Ideation Questionnaire (SIQ) is a reliable, valid 30-item self-report scale to screen for the frequency of suicidal thoughts and cognitions in adolescents. Scores range from 0 to 180, with higher scores indicating greater frequency and severity of suicidal ideation.
Time frame
Baseline, 30 days, 90 days, 180 days2
Change in suicidal behaviors
The Self-Harm Behavior Questionnaire (SHBQ) is a 32-item valid and reliable measure to assess suicidal behaviors among diverse youth. Scores range from 0 to 78, with higher scores indicating higher severity of suicidal behaviors.
Time frame
Baseline, 30 days, 90 days, 180 daysSecondary outcomes
1
Change in Suicide Ideation Severity
Investigators assess the suicide ideation severity using the Columbia-Suicide Severity Rating Scale (C-SSRS), a 6-item validated tool used to assess a person's risk for suicide. Assess suicidal ideation severity (5 items \[yes/no\]; scores range from 0 to 5, with higher scores indicating more severe suicidal ideation)
Time frame
Baseline, 30 days, 90 days, 180 days2
Reported Suicide Attempts
Investigators will assess the presence of suicidal behaviors (yes/no) over the past month. Question #6 from the Columbia-Suicide Severity Rating Scale (C-SSRS) will be used, which assesses a person's risk for suicide. A yes response indicates suicidal behaviors.
Time frame
Baseline, 30 days, 90 days, 180 daysOther outcomes
1
Change in Treatment Acceptability
The Treatment Evaluation Inventory Short Form (TEI-SF) is a 14-item, reliable, and valid measure that has been modified to assess the acceptability of CA-LINC. The total score ranges from 9 to 45, with higher scores indicating greater acceptability of the treatment.
Time frame
30 days, 90 days2
Changes in Barriers to Service Participation
The Barriers to Treatment Participation Scale is a reliable, valid 22-item scale that assesses perceived service barriers among caregivers. Higher scores indicate more severe barriers to service participation. Scores range from 22-110.
Time frame
Baseline, 30 days3
Change in Therapeutic Alliance
The Therapeutic Alliance Scales for Adolescents (TASA) is a reliable, valid 12-item scale slightly modified to assess the helping relationship between the youth/care coordinator. Scores range from 12 to 48, with higher scores indicating a stronger therapeutic alliance.
Time frame
30 days, 90 days4
Change in Cultural Humility
The Cultural Humility Scale (CHS) a reliable, valid 12-item scale to determine youth perceived cultural humility within the youth-care coordinator relationship. Scores range from 12 to 60, where higher scores indicate greater cultural humility.
Time frame
30 days, 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Robert Wood Johnson Foundation
Collaborator
Source ClinicalTrials.gov