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

NCT02332239 | Completed Results DMC

• 1 other identifier: K23MH095866
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Violence

Keywords

depression; violence; emergency department; mhealth; text message

Outcome Measures

Primary Outcomes (2)

• Change in Depressive Symptoms

  Becks Depression Inventory (BDI-2): To analyze changes in past-two-week depressive symptoms in iDOVE participants, relative to an automated health-and-safety brief intervention and text message program. The Beck Depression Inventory (BDI-2) is a 1996 revision of the BDI, developed in response to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV, which changed many of the diagnostic criteria for Major Depressive Disorder. Participants were asked to rate how they have been feeling for the past two weeks. It contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.

  Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)

• Change in Peer Violence Involvement

  The Physical Assault subscale of the Conflict Tactics Scale (CTS-2), developed by Straus et al. (1996), was used to analyze changes in past-two-month peer violence in iDOVE participants, relative to an automated health-and-safety brief intervention and text message program. There are 14 items that measure violent behavior, each scored based on how frequently the participant has experienced the behavior (0=never to 6=20+ times). Score is summed, so the minimum score possible is 14\*0=0 (lowest level of violence) and the maximum score possible is 14\*6=84 (highest level of violence).

  Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)

Secondary Outcomes (3)

• Acceptability/Feasibility: Follow Up Rate

  8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)

• Acceptability/Feasibility: Engagement of Intervention Group

  Enrollment to 16 weeks post-enrollment

• Acceptability/Feasibility: Participant Satisfaction

  8 weeks post-enrollment (close of intervention)

Study Arms (2)

iDOVE Intervention (ED+text)

EXPERIMENTAL

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

Behavioral: iDOVE Intervention (ED+text)

Control (EUC)

PLACEBO COMPARATOR

1. In-ED brief session, discussing home safety \& nutrition 2. Eight-week longitudinal home safety \& nutrition text-message program

Behavioral: Control (EUC)

Interventions

iDOVE Intervention (ED+text) 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

iDOVE Intervention (ED+text)

Control (EUC) BEHAVIORAL

1. In-ED brief session, discussing home safety \& nutrition 2. Eight-week longitudinal home safety \& nutrition text-message program

Control (EUC)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Rhode Island Hospital Emergency Department

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression; Emergencies

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1. This study was not adequately powered to show efficacy. 2. This study enrolled during a convenience sample of shifts, at a single ED, excluding non-English-speaking adolescents; these limitations may introduce bias or reduce generalizability.

Results Point of Contact

• Title: Megan L. Ranney, MD, MPH, FACEP
• Organization: Department of Emergency Medicine, Alpert Medical School, Brown University

megan_ranney@brown.edu

401-444-2557

Study Officials

• Megan Ranney, MD MPH

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: January 6, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: May 1, 2017
• Last Updated: February 5, 2020
• Results First Posted: December 7, 2017

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)