ClinicalTrials.Veeva

Menu

Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents (iDOVE2)

Lifespan logo

Lifespan

Status

Enrolling

Conditions

Violence
Depressive Disorder

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03626103
R01HD093655 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

800 participants in 4 patient groups

+ Brief ED Intervention (BI), + Text
Experimental group
Description:
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).
Treatment:
Behavioral: + Brief ED Intervention (BI)
Behavioral: + Text
+ Brief ED Intervention (BI), no Text
Experimental group
Description:
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).
Treatment:
Behavioral: + Brief ED Intervention (BI)
No Brief ED Intervention (BI), + Text
Experimental group
Description:
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.
Treatment:
Behavioral: + Text
No Brief ED Intervention (BI), no Text
No Intervention group
Description:
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.

Trial contacts and locations

2

Loading...

Central trial contact

Thomas Chun, MD; Dimitri Luzincourt, MA

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems