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

NCT ID: NCT02332239

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-05-31

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.

Conditions

Depressive Disorder; Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

iDOVE 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 CBT-based text-message program

Group Type: EXPERIMENTAL

iDOVE Intervention (ED+text)

Intervention Type: BEHAVIORAL

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

Control (EUC)

1. In-ED brief session, discussing home safety & nutrition

2. Eight-week longitudinal home safety & nutrition text-message program

Group Type: PLACEBO_COMPARATOR

Control (EUC)

Intervention Type: BEHAVIORAL

1. In-ED brief session, discussing home safety & nutrition

2. Eight-week longitudinal home safety & nutrition text-message program

Interventions

iDOVE 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

Intervention Type: BEHAVIORAL

Control (EUC)

1. In-ED brief session, discussing home safety & nutrition

2. Eight-week longitudinal home safety & nutrition text-message program

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Megan Ranney, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Rhode Island Hospital Emergency Department

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23MH095866

Identifier Type: NIH

Identifier Source: secondary_id

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K23MH095866

Identifier Type: NIH

Identifier Source: org_study_id

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