Clinical trial NCT03626103: Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents
Official title: A Technology-Augmented Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Emergency Department Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depressive Disorder
Violence
Keywords: depression
violence
emergency department
mhealth
text message
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-08-10
Enrollment: 800
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Conflict Tactics Scale-2, physical subset (CTS-2)
timeFrame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
measure: Center for Epidemiologic Studies Depression Scale Revised (CESD-R)
timeFrame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Secondary outcomes:
measure: Change in ED Visits for Assault-Related Injury
timeFrame: 12 months before enrollment and 12 months after enrollment
measure: Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)
timeFrame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
measure: Illinois Bully Scale (IBS)
timeFrame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
measure: Student School Survey
timeFrame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Other outcomes:
measure: Self-Efficacy Questionnaire for Children (SEQ-C)
timeFrame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
measure: Emotional Regulation Questionnaire for Children and Adolescents (ERQ-CA)
timeFrame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
measure: Bosworth Violence Self-Efficacy Scale
timeFrame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Providence
country: United States
facility: Rhode Island Hospital/Hasbro Children's Hospital
state: Rhode Island
Study officials:
affiliation: Yale School of Public Health
name: Megan L Ranney, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: