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

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ClinicalTrials.gov Identifier: NCT03626103
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Violence Behavioral: + Brief ED Intervention (BI) Behavioral: + Text Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Technology-Augmented Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Emergency Department Adolescents
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: + Brief ED Intervention (BI), + 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).
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

Behavioral: + 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.

Experimental: + Brief ED Intervention (BI), no Text
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)
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

Experimental: No Brief ED Intervention (BI), + 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.
Behavioral: + 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.

No Intervention: No Brief ED Intervention (BI), no Text
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.



Primary Outcome Measures :
  1. Conflict Tactics Scale-2, physical subset (CTS-2) [ Time Frame: 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)

  2. Center for Epidemiologic Studies Depression Scale Revised (CESD-R) [ Time Frame: 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)


Secondary Outcome Measures :
  1. Change in ED Visits for Assault-Related Injury [ Time Frame: 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

  2. Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI) [ Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment ]
    Change from enrollment other forms of peer violence (dating relationships)

  3. Illinois Bully Scale (IBS) [ Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment ]
    Change from enrollment other forms of peer violence (bullying)

  4. Student School Survey [ Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment ]
    Change from enrollment other forms of peer violence (bullying)


Other Outcome Measures:
  1. Self-Efficacy Questionnaire for Children (SEQ-C) [ Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment ]
    Measures emotional self-efficacy (mean score)

  2. Emotional Regulation Questionnaire for Children and Adolescents (ERQ-CA) [ Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment ]
    Measures cognitive reappraisal (score is summed, range 6 - 30)

  3. Bosworth Violence Self-Efficacy Scale [ Time Frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment ]
    Measures self-rated ability to stay out of violence (mean score)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626103


Contacts
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Contact: Megan L Ranney, MD MPH 401-444-2557 mranney@lifespan.org
Contact: John V Patena, MPH, MA 401-444-8873 jpatena2@lifespan.org

Locations
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United States, Rhode Island
Rhode Island Hospital/Hasbro Children's Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: John V Patena, MPH, MA    401-444-8873    jpatena2@lifespan.org   
Principal Investigator: Megan L Ranney, MD, MPH         
Sponsors and Collaborators
Rhode Island Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Megan L Ranney, MD MPH Rhode Island Hospital

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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03626103     History of Changes
Other Study ID Numbers: R01HD093655 ( U.S. NIH Grant/Contract )
R01HD093655 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rhode Island Hospital:
depression
violence
emergency department
mhealth
text message

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms