Clinical trial NCT02332239: Text-Message-Based Depression Prevention for High-Risk Youth in the ED
Official title: Text-Message-Based Depression Prevention for High-Risk Youth in the ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Violence
Keywords: depression
violence
emergency department
mhealth
text message
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-01-06
Enrollment: 116
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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)) and current mild-to-moderate depressive symptoms (using Patient Health Questionnaire (PHQ)-9), as identified on a brief screen administered in the ED
* accompanied by a consentable parent
* own or have access to a text-message-capable mobile phone

Exclusion Criteria:

* medically/physically unable to assent
* chief complaint of suicidal ideation, psychosis, or child abuse
* in police custody
* severe depressive symptoms

Primary outcomes:
measure: Change in Depressive Symptoms
timeFrame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
measure: Change in Peer Violence Involvement
timeFrame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
Secondary outcomes:
measure: Acceptability/Feasibility: Follow Up Rate
timeFrame: 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
measure: Acceptability/Feasibility: Engagement of Intervention Group
timeFrame: Enrollment to 16 weeks post-enrollment
measure: Acceptability/Feasibility: Participant Satisfaction
timeFrame: 8 weeks post-enrollment (close of intervention)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital Emergency Department
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Megan Ranney, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: