- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07043764
- Original Trial
Caring Contacts Via Text Message for Suicidal Adolescents After Emergency Department Discharge
Caring Texts for Adolescents to Reduce Suicide Risk
The goal of this pilot clinical trial is to learn if Caring Contacts (brief, hopeful, supportive text messages) can be delivered to adolescents with suicidal thoughts or behaviors after discharge from the emergency department, and to understand if adolescents find it acceptable to receive Caring Contacts. Researchers will also begin to explore how suicidal thoughts and behaviors change over time among participants who receive Caring Contacts along with treatment as usual, compared to participants who only receive treatment as usual.
All participants will be invited to answer survey questions when they first enroll in the study and 1, 3, 6, and 12 months after their emergency department visit. Some participants will receive Caring Contacts (brief, hopeful, supportive text messages) after their emergency department visit. Some participants will be invited to complete an interview about their experiences receiving Caring Contacts.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer A. Hoffmann, MD, MS
- Phone Number: 312-227-4000
- Email: jhoffmann@luriechildrens.org
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
-
Contact:
- Jennifer A. Hoffmann, MD, MS
- Phone Number: 312-227-4000
- Email: jhoffmann@luriechildrens.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 12 to <18 years of age
- Present to the emergency department with suicidal thoughts or behaviors as indicated by the Ask Suicide-Screening Questions (ASQ)
- Have a cell phone that can receive text messages
- Proficient in English
- Anticipated disposition of discharge from the emergency department
Exclusion Criteria:
- In care of the Department of Children and Family Services
- Unable to participate meaningfully in assent, assessments, or the intervention, as determined by the treating clinician, including any of the following: acute or chronic cognitive impairment, acute psychosis, current severe agitation, current alcohol or drug intoxication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Treatment as Usual
Treatment as usual consists of a suicide risk assessment during the emergency department visit, determination of disposition, safety planning, provision of crisis resources, and coordination of follow-up mental health services if indicated.
|
|
|
Experimental: Caring Contacts
In addition to Treatment as Usual, participants will receive Caring Contacts, consisting of brief, hopeful, supportive text messages.
|
Caring Contacts are brief, hopeful, supportive text messages.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Columbia-Suicide Severity Rating Scale (C-SSRS) Self-Report Recent
Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
|
The Columbia-Suicide Severity Rating Scale (C-SSRS) Self-Report Recent measures recent suicidal ideation and behavior on a scale of 0-5, with higher scores indicating greater severity.
|
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jennifer A. Hoffmann, MD, MS, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-6680
- K23MH135206 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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