Depressive DisorderiDOVENCT02332239
Text-Message-Based Depression Prevention for High-Risk Youth in the ED
A study testing iDOVE Intervention (ED+text) in people with Depressive Disorder and Violence, run by Rhode Island Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depressive Disorder, Violence
- What is being tested?
- iDOVE Intervention (ED+text)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- medically/physically unable to assent
- chief complaint of suicidal ideation, psychosis, or child abuse
- in police custody
- severe depressive symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital Emergency Department
Providence, Rhode Island, 02903
About this study
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.
Read the 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
- Being tested
- iDOVE Intervention (ED+text), Control (EUC)
- Keywords
- depression, violence, emergency department, mhealth, text message
- Medical subject headings
- Depressive Disorder, Depression, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iDOVE Intervention (ED+text)Behavioural
- 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)Behavioural
- In-ED brief session, discussing home safety \& nutrition
- Eight-week longitudinal home safety \& nutrition text-message program
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Control (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Retention Rate: % of consented participants who completed follow up
Measured: 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
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.
Measured: Enrollment to 16 weeks post-enrollment
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.
Measured: 8 weeks post-enrollment (close of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Megan Ranney, MD MPH, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332239
- Sponsor's protocol ID
- K23MH095866
- Other IDs
- K23MH095866
- Acronym
- iDOVE
- Status last verified
- Jan 2020
- First submitted
- 29 Dec 2014
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Less than 150 randomized controlled trial (RCT) participants
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text-Message-Based Depression Prevention for High-Risk Youth in the ED
- ClinicalTrials.gov ID
- NCT02332239
- Acronym / sponsor ID
- iDOVE / K23MH095866
- Conditions
- Depressive Disorder, Violence
- Keywords
- depression, violence, emergency department, mhealth, text message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Posted 7 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iDOVE Intervention (ED+text) | Experimental | 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 CBT-based text-message program |
| Control (EUC) | Placebo comparator | Behavioral: Control (EUC)1. In-ED brief session, discussing home safety \& nutrition 2. Eight-week longitudinal home safety \& nutrition text-message program |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- medically/physically unable to assent
- chief complaint of suicidal ideation, psychosis, or child abuse
- in police custody
- severe depressive symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | iDOVE Intervention (ED+text) |
| Control (EUC)1. In-ED brief session, discussing home safety \& nutrition 2. Eight-week longitudinal home safety \& nutrition text-message program | Behavioural | Control (EUC) |
Primary outcome
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.
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).
3 secondary outcomes
Acceptability/Feasibility: Follow Up Rate
Time frame: 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
Acceptability/Feasibility: Engagement of Intervention Group
Time frame: Enrollment to 16 weeks post-enrollment
Acceptability/Feasibility: Participant Satisfaction
Time frame: 8 weeks post-enrollment (close of intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Less than 150 randomized controlled trial (RCT) participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Ranney, MD MPH principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iDOVE Intervention (ED+text) in people with Depressive Disorder and Violence, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms (time frame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.