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

NCT03626103 | Completed DMC

• 1 other identifier: R01HD093655
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 2

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.

Conditions

Depressive Disorder; Violence

Keywords

depression; violence; emergency department; mhealth; text message

Outcome Measures

Primary Outcomes (2)

• Conflict Tactics Scale-2, physical subset (CTS-2)

  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)

  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 Outcomes (4)

• Change in ED Visits for Assault-Related Injury

  12 months before enrollment and 12 months after enrollment

• Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)

  Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment

• Illinois Bully Scale (IBS)

  Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment

• Student School Survey

  Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment

Other Outcomes (3)

• Self-Efficacy Questionnaire for Children (SEQ-C)

  Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment

• Emotional Regulation Questionnaire for Children and Adolescents (ERQ-CA)

  Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment

• Bosworth Violence Self-Efficacy Scale

  Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment

Study Arms (4)

+ Brief ED Intervention (BI), + Text

EXPERIMENTAL

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).

Behavioral: + Brief ED Intervention (BI); Behavioral: + Text

+ Brief ED Intervention (BI), no Text

EXPERIMENTAL

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).

Behavioral: + Brief ED Intervention (BI)

No Brief ED Intervention (BI), + Text

EXPERIMENTAL

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.

Behavioral: + Text

No Brief ED Intervention (BI), no Text

NO INTERVENTION

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.

Interventions

+ Brief ED Intervention (BI) BEHAVIORAL

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

+ Brief ED Intervention (BI), + Text; + Brief ED Intervention (BI), no Text

+ Text BEHAVIORAL

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), + Text; No Brief ED Intervention (BI), + Text

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Rhode Island Hospital/Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression; Emergencies

Interventions

Communication Devices for People with Disabilities

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Self-Help Devices; Equipment and Supplies

Study Officials

• Megan L Ranney, MD MPH

  Yale School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 10, 2018
• Study Start: August 1, 2018
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)