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

Primary Purpose

Depressive Disorder, Violence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iDOVE Intervention (ED+text)
Control (EUC)
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depressive Disorder focused on measuring depression, violence, emergency department, mhealth, text message

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rhode Island Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

iDOVE Intervention (ED+text)

Control (EUC)

Arm Description

In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention Eight-week longitudinal tailored CBT-based text-message program

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Acceptability/Feasibility: Follow Up Rate
Retention Rate: % of consented participants who completed follow up
Acceptability/Feasibility: Engagement of Intervention Group
Among the intervention group, how many participants responded to at least one of the daily text message queries, and how many requested on-demand support text-messages.
Acceptability/Feasibility: Participant Satisfaction
The Customer Satisfaction Questionnaire (CSQ-8) developed by Larsen et al. (1979) is an 8-item survey where each item is scored 1 (poor) to 4 (excellent). It is scored by summing the individual item scores to produce a range of 8 to 32, with high scores indicating greater satisfaction.

Full Information

First Posted
December 29, 2014
Last Updated
January 30, 2020
Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02332239
Brief Title
Text-Message-Based Depression Prevention for High-Risk Youth in the ED
Acronym
iDOVE
Official Title
Text-Message-Based Depression Prevention for High-Risk Youth in the ED
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Violence
Keywords
depression, violence, emergency department, mhealth, text message

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iDOVE Intervention (ED+text)
Arm Type
Experimental
Arm Description
In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention Eight-week longitudinal tailored CBT-based text-message program
Arm Title
Control (EUC)
Arm Type
Placebo Comparator
Arm Description
In-ED brief session, discussing home safety & nutrition Eight-week longitudinal home safety & nutrition text-message program
Intervention Type
Behavioral
Intervention Name(s)
iDOVE Intervention (ED+text)
Intervention Description
In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention Eight-week longitudinal tailored text-message program
Intervention Type
Behavioral
Intervention Name(s)
Control (EUC)
Intervention Description
In-ED brief session, discussing home safety & nutrition Eight-week longitudinal home safety & nutrition text-message program
Primary Outcome Measure Information:
Title
Change in Depressive Symptoms
Description
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.
Time Frame
Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
Title
Change in Peer Violence Involvement
Description
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).
Time Frame
Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
Secondary Outcome Measure Information:
Title
Acceptability/Feasibility: Follow Up Rate
Description
Retention Rate: % of consented participants who completed follow up
Time Frame
8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
Title
Acceptability/Feasibility: Engagement of Intervention Group
Description
Among the intervention group, how many participants responded to at least one of the daily text message queries, and how many requested on-demand support text-messages.
Time Frame
Enrollment to 16 weeks post-enrollment
Title
Acceptability/Feasibility: Participant Satisfaction
Description
The Customer Satisfaction Questionnaire (CSQ-8) developed by Larsen et al. (1979) is an 8-item survey where each item is scored 1 (poor) to 4 (excellent). It is scored by summing the individual item scores to produce a range of 8 to 32, with high scores indicating greater satisfaction.
Time Frame
8 weeks post-enrollment (close of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Ranney, MD MPH
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital Emergency Department
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Less than 150 randomized controlled trial (RCT) participants

Learn more about this trial

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

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