search
Back to results

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

Primary Purpose

Depressive Disorder, Violence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
+ Brief ED Intervention (BI)
+ Text
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depressive Disorder focused on measuring depression, violence, emergency department, mhealth, text message

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Rhode Island Hospital/Hasbro Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

+ Brief ED Intervention (BI), + Text

+ Brief ED Intervention (BI), no Text

No Brief ED Intervention (BI), + Text

No Brief ED Intervention (BI), no Text

Arm 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).

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).

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.

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.

Outcomes

Primary Outcome Measures

Conflict Tactics Scale-2, physical subset (CTS-2)
Change from enrollment physical peer violence (score is summed, range 0 - 56)
Center for Epidemiologic Studies Depression Scale Revised (CESD-R)
Change from enrollment depressive symptoms (score is summed based on symptom group, range 0 - 80)

Secondary Outcome Measures

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
Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)
Change from enrollment other forms of peer violence (dating relationships)
Illinois Bully Scale (IBS)
Change from enrollment other forms of peer violence (bullying)
Student School Survey
Change from enrollment other forms of peer violence (bullying)

Full Information

First Posted
July 23, 2018
Last Updated
December 21, 2020
Sponsor
Rhode Island Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT03626103
Brief Title
Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents
Acronym
iDOVE2
Official Title
A Technology-Augmented Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Emergency Department Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Violence
Keywords
depression, violence, emergency department, mhealth, text message

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
+ Brief ED Intervention (BI), + Text
Arm Type
Experimental
Arm 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).
Arm Title
+ Brief ED Intervention (BI), no Text
Arm Type
Experimental
Arm 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).
Arm Title
No Brief ED Intervention (BI), + Text
Arm Type
Experimental
Arm 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.
Arm Title
No Brief ED Intervention (BI), no Text
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
+ Brief ED Intervention (BI)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
+ Text
Intervention Description
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.
Primary Outcome Measure Information:
Title
Conflict Tactics Scale-2, physical subset (CTS-2)
Description
Change from enrollment physical peer violence (score is summed, range 0 - 56)
Time Frame
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Title
Center for Epidemiologic Studies Depression Scale Revised (CESD-R)
Description
Change from enrollment depressive symptoms (score is summed based on symptom group, range 0 - 80)
Time Frame
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Secondary Outcome Measure Information:
Title
Change in ED Visits for Assault-Related Injury
Description
Review of hospital system-wide Electronic Medical Record and state-wide Health Information Exchange to identify ED visits for peer assault
Time Frame
12 months before enrollment and 12 months after enrollment
Title
Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)
Description
Change from enrollment other forms of peer violence (dating relationships)
Time Frame
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Title
Illinois Bully Scale (IBS)
Description
Change from enrollment other forms of peer violence (bullying)
Time Frame
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Title
Student School Survey
Description
Change from enrollment other forms of peer violence (bullying)
Time Frame
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Other Pre-specified Outcome Measures:
Title
Self-Efficacy Questionnaire for Children (SEQ-C)
Description
Measures emotional self-efficacy (mean score)
Time Frame
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Title
Emotional Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Description
Measures cognitive reappraisal (score is summed, range 6 - 30)
Time Frame
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Title
Bosworth Violence Self-Efficacy Scale
Description
Measures self-rated ability to stay out of violence (mean score)
Time Frame
Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan L Ranney, MD MPH
Phone
401-444-2557
Email
mranney@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
John V Patena, MPH, MA
Phone
401-444-8873
Email
jpatena2@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan L Ranney, MD MPH
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital/Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John V Patena, MPH, MA
Phone
401-444-8873
Email
jpatena2@lifespan.org
First Name & Middle Initial & Last Name & Degree
Megan L Ranney, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs