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

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ClinicalTrials.gov Identifier: NCT02332239
Recruitment Status : Completed
First Posted : January 6, 2015
Results First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rhode Island Hospital

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Violence Behavioral: iDOVE Intervention (ED+text) Behavioral: Control (EUC) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Text-Message-Based Depression Prevention for High-Risk Youth in the ED
Study Start Date : February 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Behavioral: 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

Placebo Comparator: Control (EUC)
  1. In-ED brief session, discussing home safety & nutrition
  2. Eight-week longitudinal home safety & nutrition text-message program
Behavioral: Control (EUC)
  1. In-ED brief session, discussing home safety & nutrition
  2. Eight-week longitudinal home safety & nutrition text-message program




Primary Outcome Measures :
  1. Change in Depressive Symptoms [ Time Frame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention) ]
    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.

  2. Change in Peer Violence Involvement [ Time Frame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention) ]
    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 :
  1. Acceptability/Feasibility: Follow Up Rate [ Time Frame: 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention) ]
    Retention Rate: % of consented participants who completed follow up

  2. Acceptability/Feasibility: Engagement of Intervention Group [ Time Frame: Enrollment to 16 weeks post-enrollment ]
    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.

  3. Acceptability/Feasibility: Participant Satisfaction [ Time Frame: 8 weeks post-enrollment (close of intervention) ]
    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.



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332239


Locations
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United States, Rhode Island
Rhode Island Hospital Emergency Department
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Megan Ranney, MD MPH Rhode Island Hospital
  Study Documents (Full-Text)

Documents provided by Rhode Island Hospital:
Informed Consent Form  [PDF] November 12, 2015


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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT02332239     History of Changes
Other Study ID Numbers: K23MH095866 ( U.S. NIH Grant/Contract )
K23MH095866 ( U.S. NIH Grant/Contract )
First Posted: January 6, 2015    Key Record Dates
Results First Posted: December 7, 2017
Last Update Posted: December 7, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Less than 150 randomized controlled trial (RCT) participants

Keywords provided by Rhode Island Hospital:
depression
violence
emergency department
mhealth
text message

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders