Depressive DisorderiDOVE2NCT03626103
Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents
A study testing + Brief ED Intervention (BI) and + Text in people with Depressive Disorder and Violence, run by Rhode Island Hospital at 2 sites in United States.
Trial summary
The purpose of this investigation is to test the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens), and to determine the most potent and parsimonious combination of intervention components for preventing… 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?
- + Brief ED Intervention (BI) and + Text
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2018to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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-2) score ≥1), as identified on a brief screen administered in the ED
- reporting past 2-week mild-to-moderate depressive symptoms (using Patient Health Questionnaire (PHQ-9) score 5-19), as identified on a brief screen administered in the ED
- Accompanied by a parent/guardian who is present and able to consent
- Possession of a cell phone with text-messaging capability
Who cannot join
- Chief complaint of suicidality, psychosis, sexual assault, or child abuse
- In police or child protective services' custody (as per state law)
- Unable to assent
- In need of emergency psychiatric care
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale New Haven Hospital
New Haven, Connecticut, 06510
Rhode Island Hospital/Hasbro Children's Hospital
Providence, Rhode Island, 02903
About this study
Official title: A Technology-Augmented Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Emergency Department Adolescents
The purpose of this investigation is to test the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens), and to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.
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 expand on the PI's pilot randomized controlled trial (RCT) of iDOVE (K23 MH095866; PI: Ranney) by testing the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens). The investigators will use a 2x2 factorial design to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.
Participants will be identified in the course of usual clinical care in the ED. If eligible, parents will be consented and participants assented. Participants will complete a baseline assessment and will be randomized to one of four groups: Brief ED Intervention (BI) + Text; BI + No Text; No BI + Text; or No BI + No Text. Youth in the Text arm who show no signal of improvement at 7 days, per daily self-reported mood ratings, will be re-randomized to additional "LiveText" (once-weekly real-time micro-counseling via text) or to continue with standard, automated Text intervention curriculum.
At baseline and follow-ups at 2 months, 4 months, and 8 months, participants will complete assessments on depressive symptoms, violence, cognitive/behavioral skill-sets, and resource utilization.
- Conditions
- Depressive Disorder, Violence
- Being tested
- + Brief ED Intervention (BI), + Text
- 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.
+ Brief ED Intervention (BI)Behavioural
Brief ED Intervention (BI): A 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant
+ TextBehavioural
Text: 8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills. Those that do not show improvement in mood after 7 days will be randomized into LiveText.
| Study group | Role | What they receive |
|---|---|---|
| + Brief ED Intervention (BI), + Text | Experimental | Participants receive both the Brief ED Intervention component (a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant) and the Text Message Intervention component (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills). Receives: Behavioral: + Brief ED Intervention (BI); Behavioral: + Text |
| + Brief ED Intervention (BI), no Text | Experimental | Participants receive the Brief ED Intervention component only (which is a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant). Receives: Behavioral: + Brief ED Intervention (BI) |
| No Brief ED Intervention (BI), + Text | Experimental | Participants receive the Text Message Intervention component only (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills). Participants receive a brochure containing online and community resources for violence and depression prevention instead of the Brief ED Intervention component. Receives: Behavioral: + Text |
| No Brief ED Intervention (BI), no Text | No intervention | Participants receive neither the Brief ED Intervention component, nor the Text Message Intervention component. Participants receive a brochure containing online and community resources for violence and depression prevention, instead of the Brief ED Intervention component. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conflict Tactics Scale-2, physical subset (CTS-2)
Change from enrollment physical peer violence (score is summed, range 0 - 56)
Measured: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Center for Epidemiologic Studies Depression Scale Revised (CESD-R)
Change from enrollment depressive symptoms (score is summed based on symptom group, range 0 - 80)
Measured: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Secondary outcomes (4)
Change in ED Visits for Assault-Related Injury
Review of hospital system-wide Electronic Medical Record and state-wide Health Information Exchange to identify ED visits for peer assault
Measured: 12 months before enrollment and 12 months after enrollment
Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)
Change from enrollment other forms of peer violence (dating relationships)
Measured: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Illinois Bully Scale (IBS)
Change from enrollment other forms of peer violence (bullying)
Measured: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Student School Survey
Change from enrollment other forms of peer violence (bullying)
Measured: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Aug 2018
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Megan L Ranney, MD MPH, Principal investigator, Yale School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626103
- Sponsor's protocol ID
- R01HD093655
- Other IDs
- R01HD093655
- Acronym
- iDOVE2
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2018
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-Augmented Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Emergency Department Adolescents
- ClinicalTrials.gov ID
- NCT03626103
- Acronym / sponsor ID
- iDOVE2 / R01HD093655
- Conditions
- Depressive Disorder, Violence
- Keywords
- depression, violence, emergency department, mhealth, text message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
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 investigation is to test the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens), and to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.
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 expand on the PI's pilot randomized controlled trial (RCT) of iDOVE (K23 MH095866; PI: Ranney) by testing the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens). The investigators will use a 2x2 factorial design to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.
Participants will be identified in the course of usual clinical care in the ED. If eligible, parents will be consented and participants assented. Participants will complete a baseline assessment and will be randomized to one of four groups: Brief ED Intervention (BI) + Text; BI + No Text; No BI + Text; or No BI + No Text. Youth in the Text arm who show no signal of improvement at 7 days, per daily self-reported mood ratings, will be re-randomized to additional "LiveText" (once-weekly real-time micro-counseling via text) or to continue with standard, automated Text intervention curriculum.
At baseline and follow-ups at 2 months, 4 months, and 8 months, participants will complete assessments on depressive symptoms, violence, cognitive/behavioral skill-sets, and resource utilization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| + Brief ED Intervention (BI), + Text | Experimental | Behavioral: + Brief ED Intervention (BI), Behavioral: + TextParticipants receive both the Brief ED Intervention component (a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant) and the Text Message Intervention component (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills). |
| + Brief ED Intervention (BI), no Text | Experimental | Behavioral: + Brief ED Intervention (BI)Participants receive the Brief ED Intervention component only (which is a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant). |
| No Brief ED Intervention (BI), + Text | Experimental | Behavioral: + TextParticipants receive the Text Message Intervention component only (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills). Participants receive a brochure containing online and community resources for violence and depression prevention instead of the Brief ED Intervention component. |
| No Brief ED Intervention (BI), no Text | No intervention | –Participants receive neither the Brief ED Intervention component, nor the Text Message Intervention component. Participants receive a brochure containing online and community resources for violence and depression prevention, instead of the Brief ED Intervention component. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 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-2) score ≥1), as identified on a brief screen administered in the ED
- reporting past 2-week mild-to-moderate depressive symptoms (using Patient Health Questionnaire (PHQ-9) score 5-19), as identified on a brief screen administered in the ED
- Accompanied by a parent/guardian who is present and able to consent
Key exclusion criteria (4 listed)
- Chief complaint of suicidality, psychosis, sexual assault, or child abuse
- In police or child protective services' custody (as per state law)
- Unable to assent
- In need of emergency psychiatric care
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 |
|---|---|---|
| + Brief ED Intervention (BI)Brief ED Intervention (BI): A 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant | Behavioural | + Brief ED Intervention (BI), + Text, + Brief ED Intervention (BI), no Text |
| + TextText: 8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills. Those that do not show improvement in mood after 7 days will be randomized into LiveText. | Behavioural | + Brief ED Intervention (BI), + Text, No Brief ED Intervention (BI), + Text |
Primary outcome
Conflict Tactics Scale-2, physical subset (CTS-2)
Time frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Change from enrollment physical peer violence (score is summed, range 0 - 56)
Center for Epidemiologic Studies Depression Scale Revised (CESD-R)
Time frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Change from enrollment depressive symptoms (score is summed based on symptom group, range 0 - 80)
4 secondary outcomes
Change in ED Visits for Assault-Related Injury
Time frame: 12 months before enrollment and 12 months after enrollment
Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)
Time frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Illinois Bully Scale (IBS)
Time frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Student School Survey
Time frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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 L Ranney, MD MPH principal investigator
Yale School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing + Brief ED Intervention (BI) and + Text in people with Depressive Disorder and Violence, run by Rhode Island Hospital at 2 sites 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 6 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Conflict Tactics Scale-2, physical subset (CTS-2) (time frame: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment). 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 29 Apr 2026.