- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03626103
Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents (iDOVE2)
A Technology-Augmented Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Emergency Department Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Peer violence and depressive symptoms have mutual, reinforcing negative impacts on teens' emotional and behavioral regulation strategies.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Yale New Haven Hospital
-
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital/Hasbro Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English-speaking
- 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:
- Chief complaint of suicidality, psychosis, sexual assault, or child abuse
- In police or child protective services' custody (as per state law)
- Unable to assent
- In need of emergency psychiatric care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: + 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): A 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant
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.
|
|
Experimental: + 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): A 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant
|
|
Experimental: 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: 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 Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conflict Tactics Scale-2, physical subset (CTS-2)
Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
Change from enrollment physical peer violence (score is summed, range 0 - 56)
|
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
|
Center for Epidemiologic Studies Depression Scale Revised (CESD-R)
Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
Change from enrollment depressive symptoms (score is summed based on symptom group, range 0 - 80)
|
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in ED Visits for Assault-Related Injury
Time Frame: 12 months before enrollment and 12 months after enrollment
|
Review of hospital system-wide Electronic Medical Record and state-wide Health Information Exchange to identify ED visits for peer assault
|
12 months before enrollment and 12 months after enrollment
|
|
Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)
Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
Change from enrollment other forms of peer violence (dating relationships)
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Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
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Illinois Bully Scale (IBS)
Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
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Change from enrollment other forms of peer violence (bullying)
|
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
|
Student School Survey
Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
Change from enrollment other forms of peer violence (bullying)
|
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy Questionnaire for Children (SEQ-C)
Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
Measures emotional self-efficacy (mean score)
|
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
|
Emotional Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
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Measures cognitive reappraisal (score is summed, range 6 - 30)
|
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
|
|
Bosworth Violence Self-Efficacy Scale
Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
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Measures self-rated ability to stay out of violence (mean score)
|
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Megan L Ranney, MD MPH, Yale School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HD093655 (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
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