Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents
NCT ID: NCT03626103
Last Updated: 2024-10-23
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
800 participants
INTERVENTIONAL
2018-08-01
2025-02-28
Brief Summary
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Detailed Description
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The emergency department (ED) is the primary source of care for many high-risk teens. It provides an opportunity to initiate preventive interventions, to complement existing mental health treatment or to stand alone for those who may lack access to formal care. Personalized text-message interventions are accessible, feasible, and may be effective with these adolescents.
The purpose of this study is to expand on the PI's pilot randomized controlled trial (RCT) of iDOVE (K23 MH095866; PI: Ranney) by testing the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens). The investigators will use a 2x2 factorial design to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.
Participants will be identified in the course of usual clinical care in the ED. If eligible, parents will be consented and participants assented. Participants will complete a baseline assessment and will be randomized to one of four groups: Brief ED Intervention (BI) + Text; BI + No Text; No BI + Text; or No BI + No Text. Youth in the Text arm who show no signal of improvement at 7 days, per daily self-reported mood ratings, will be re-randomized to additional "LiveText" (once-weekly real-time micro-counseling via text) or to continue with standard, automated Text intervention curriculum.
At baseline and follow-ups at 2 months, 4 months, and 8 months, participants will complete assessments on depressive symptoms, violence, cognitive/behavioral skill-sets, and resource utilization.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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+ Brief ED Intervention (BI), + Text
Participants receive both the Brief ED Intervention component (a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant) and the Text Message Intervention component (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills).
+ Brief ED Intervention (BI)
Brief ED Intervention (BI): A 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant
+ Text
Text: 8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills. Those that do not show improvement in mood after 7 days will be randomized into LiveText.
+ Brief ED Intervention (BI), no Text
Participants receive the Brief ED Intervention component only (which is a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant).
+ Brief ED Intervention (BI)
Brief ED Intervention (BI): A 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant
No Brief ED Intervention (BI), + Text
Participants receive the Text Message Intervention component only (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills). Participants receive a brochure containing online and community resources for violence and depression prevention instead of the Brief ED Intervention component.
+ Text
Text: 8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills. Those that do not show improvement in mood after 7 days will be randomized into LiveText.
No Brief ED Intervention (BI), no Text
Participants receive neither the Brief ED Intervention component, nor the Text Message Intervention component. Participants receive a brochure containing online and community resources for violence and depression prevention, instead of the Brief ED Intervention component.
No interventions assigned to this group
Interventions
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+ Brief ED Intervention (BI)
Brief ED Intervention (BI): A 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant
+ Text
Text: 8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills. Those that do not show improvement in mood after 7 days will be randomized into LiveText.
Eligibility Criteria
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Inclusion Criteria
* presenting to the emergency department for routine care
* reporting past-year physical violence (using a modified version of The Revised Conflict Tactics Scales (CTS-2) score ≥1), as identified on a brief screen administered in the ED
* reporting past 2-week mild-to-moderate depressive symptoms (using Patient Health Questionnaire (PHQ-9) score 5-19), as identified on a brief screen administered in the ED
* Accompanied by a parent/guardian who is present and able to consent
* Possession of a cell phone with text-messaging capability
Exclusion Criteria
* In police or child protective services' custody (as per state law)
* Unable to assent
* In need of emergency psychiatric care
13 Years
17 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Rhode Island Hospital
OTHER
Responsible Party
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Principal Investigators
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Megan L Ranney, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Yale School of Public Health
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Rhode Island Hospital/Hasbro Children's Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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