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

Depressive Disorder Clinical Trial

— iDOVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332239
• Other study ID #: K23MH095866
• Secondary ID: K23MH095866
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: May 2017

Study information

• Verified date: January 2020
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Violence

Intervention

Behavioral:
• iDOVE Intervention (ED+text)
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
• Control (EUC)
In-ED brief session, discussing home safety & nutrition Eight-week longitudinal home safety & nutrition text-message program

Locations

Country	Name	City	State
United States	Rhode Island Hospital Emergency Department	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Acceptability/Feasibility: Follow Up Rate	Retention Rate: % of consented participants who completed follow up	8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
Secondary	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.	Enrollment to 16 weeks post-enrollment
Secondary	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.	8 weeks post-enrollment (close of intervention)