- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06660199
Text-based Support for Parents of Adolescents Following an Emergency Department Visits (TESP)
Effectiveness of Text-based Support for Parents of Suicidal Adolescents Following Emergency Department Visits
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ewa Czyz, Ph.D.
- Phone Number: 734-764-9466
- Email: ewac@umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Principal Investigator:
- Ewa Czyz, PhD
-
Contact:
- Ewa Czyz, PhD
- Phone Number: 734-764-9466
- Email: ewac@umich.edu
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Flint, Michigan, United States, 48503
- Recruiting
- Hurley Medical Center
-
Contact:
- Courtney Mangus, M.D.
- Phone Number: 810-262-9429
- Email: cmangus@med.umich.edu
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Principal Investigator:
- Courtney Mangus, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescent (13-17 years old) who present to Emergency Department (ED) due to (1) last-week suicidal ideation and/or (2) last-month suicide attempt, and their caregiver.
Exclusion Criteria:
Adolescents who are:
- medically unstable
- presenting with severe cognitive impairment, altered mental status, severe aggression/agitation
- presenting without a legal guardian
- whose parent does not own a cell phone
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: Standard ED care
|
|
|
Experimental: Standard ED care with a text-based intervention
This arm incorporates adolescent-centered (A-C) and parent-centered (P-C) texting components Parents in the intervention arm will receive up to 3 text messages per day over six weeks after ED discharge: daily A-C text and up to two P-C messages. The P-C component includes an embedded micro-randomized trial (MRT), and parents will be randomized twice each day over the six-week intervention to either receive or not receive a P-C message. |
Parents randomized to the texting intervention will receive up to 3 messages each day for 6 weeks: The intervention is comprised of adolescent-centered (A-C) texts focusing on parental adherence to recommended suicide prevention strategies to promote adolescents' safety and parent-centered (P-C) texts focused on improving parents' own well-being.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aim 1 (primary aim): likelihood of suicidal behavior (actual, interrupted, or aborted attempts)
Time Frame: 12-week follow-up
|
Suicidal behavior encompasses actual, interrupted, and aborted suicide attempts.
Measured with the behavioral subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS),and supplemented with available medical chart data.
|
12-week follow-up
|
|
Aim 2 (secondary aim) severity of parental stress
Time Frame: Up to 6 weeks
|
Measured with twice daily surveys over the 6-week intervention
|
Up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aim 1 (primary aim): -time- to- suicidal behavior (actual, interrupted, or aborted suicide attempts
Time Frame: 24-week follow-up
|
Measured with the behavioral subscale of C-SSRS and supplemented with available chart data.
|
24-week follow-up
|
|
Aim 1 (primary aim): time- to- return ED visit
Time Frame: 24-week follow-up.
|
24-week follow-up.
|
|
|
Aim 2 (secondary aim): parental negative affect
Time Frame: Up to 6 weeks
|
Measured with twice daily surveys over the 6-week intervention.
|
Up to 6 weeks
|
|
Aim 2 (secondary aim) parental positive affect
Time Frame: Up to 6 weeks
|
Measured with twice daily surveys over the 6-week intervention.
|
Up to 6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ewa Czyz, Ph.D., University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
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
- HUM00254540
- 1R01MH137012-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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