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

Depressive Disorder Clinical Trial

— iDOVE2  

Official title:

A Technology-Augmented Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Emergency Department Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03626103
• Other study ID #: R01HD093655
• Secondary ID: R01HD093655
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Rhode Island Hospital
• Contact: Thomas Chun, MD
• Phone: (401) 444-9927
• Email: thomas_chun[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Violence

Intervention

Behavioral:
• + 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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Rhode Island Hospital/Hasbro Children's Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Efficacy Questionnaire for Children (SEQ-C)	Measures emotional self-efficacy (mean score)	Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Other	Emotional Regulation Questionnaire for Children and Adolescents (ERQ-CA)	Measures cognitive reappraisal (score is summed, range 6 - 30)	Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Other	Bosworth Violence Self-Efficacy Scale	Measures self-rated ability to stay out of violence (mean score)	Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Primary	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
Primary	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	Change in ED Visits for Assault-Related Injury	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
Secondary	Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)	Change from enrollment other forms of peer violence (dating relationships)	Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Secondary	Illinois Bully Scale (IBS)	Change from enrollment other forms of peer violence (bullying)	Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Secondary	Student School Survey	Change from enrollment other forms of peer violence (bullying)	Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment