Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents

Not Applicable

Active, not recruiting

• Conditions: Depressive Disorder; Violence
• Interventions: Behavioral: + Brief ED Intervention (BI); Behavioral: + Text

• Registration Number: NCT03626103
• Lead Sponsor: Rhode Island Hospital

Brief Summary

The purpose of this investigation is to test the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens), and to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.

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 Timeline

• Study First Submitted: 2018-07-23
• Study Start: 2018-08-01
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
+ Brief ED Intervention (BI), + Text	+ Brief ED Intervention (BI)	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), + Text	+ 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), no Text	+ Brief ED Intervention (BI)	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).
No Brief ED Intervention (BI), + Text	+ 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.

Primary Outcome Measures

Name	Time	Method
Center for Epidemiologic Studies Depression Scale Revised (CESD-R)	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)
Conflict Tactics Scale-2, physical subset (CTS-2)	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)

Secondary Outcome Measures

Name	Time	Method
Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)	Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment	Change from enrollment other forms of peer violence (dating relationships)
Change in ED Visits for Assault-Related Injury	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
Illinois Bully Scale (IBS)	Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment	Change from enrollment other forms of peer violence (bullying)
Student School Survey	Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment	Change from enrollment other forms of peer violence (bullying)

Trial Locations

Locations (2)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Rhode Island Hospital/Hasbro Children's Hospital; 🇺🇸 Providence, Rhode Island, United States