Trials / Active Not Recruiting
Active Not RecruitingNCT03626103
Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents
A Technology-Augmented Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Emergency Department Adolescents
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- Sponsor
- Rhode Island Hospital · Academic / Other
- Sex
- All
- Age
- 13 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2025-02-01
- Completion
- 2025-02-01
- First posted
- 2018-08-10
- Last updated
- 2024-10-23
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03626103. Inclusion in this directory is not an endorsement.