Clinical Trials Directory

Trials / Completed

CompletedNCT02332239

Text-Message-Based Depression Prevention for High-Risk Youth in the ED

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
116 (actual)
Sponsor
Rhode Island Hospital · Academic / Other
Sex
All
Age
13 Years – 17 Years
Healthy volunteers
Not accepted

Summary

The purpose of this randomized controlled study is to evaluate acceptability and feasibility, and to gather preliminary data about efficacy, of "iDOVE," a brief emergency department introductory session + longitudinal automated text-message depression prevention program for high-risk teens.

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 test the feasibility and acceptability of a novel text-message augmented depression prevention intervention, "iDOVE." Drawing on effective cognitive behavioral therapy (CBT) and motivational interviewing (MI) depression and violence prevention interventions, a brief in-ED session will introduce basic cognitive and behavioral strategies. Following ED discharge, eight weeks of tailored CBT-informed daily text messages will be sent, to enhance skills and remind participants of self-determined goals. Participants will be identified in the course of usual ED care. If eligible, parents will be consented and participants assented. Participants will complete a baseline assessment and will be randomized to experimental (ED+text, n=50) or enhanced usual care (EUC, n=50) care, using stratified block randomization. ED+text group participants will participate in a brief, structured in-ED introduction on CBT and the iDOVE program, followed by 8 weeks of tailored, two-way, CBT-and MI-informed automated text messages (short message service, SMS). EUC group participants will participate in a brief, structured, in-ED introduction to home safety \& nutrition, followed by 8 weeks of automated SMS regarding home safety \& nutrition. The current standard of care for these patients is no care: no depression or violence screening assessment protocols are currently used in our ED. Both ED+text and EUC conditions therefore exceed current levels of care. At baseline, 8 week follow-up, and 16 week follow-up, participants will complete assessments on depressive symptoms, violence, cognitive/behavioral skill-sets, and resource utilization. At the 8-week follow-up, standardized qualitative and quantitative process measures will be administered to assess efficacy, acceptability, usability, and feasibility.

Conditions

Interventions

TypeNameDescription
BEHAVIORALiDOVE Intervention (ED+text)1. In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2. Eight-week longitudinal tailored text-message program
BEHAVIORALControl (EUC)1. In-ED brief session, discussing home safety \& nutrition 2. Eight-week longitudinal home safety \& nutrition text-message program

Timeline

Start date
2015-02-01
Primary completion
2017-02-01
Completion
2017-05-01
First posted
2015-01-06
Last updated
2020-02-05
Results posted
2017-12-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02332239. Inclusion in this directory is not an endorsement.