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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD093655 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| + 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). |
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| + 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). |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| + Brief ED Intervention (BI) | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Conflict Tactics Scale-2, physical subset (CTS-2) | Change from enrollment physical peer violence (score is summed, range 0 - 56) | 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) | Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months before enrollment and 12 months after enrollment |
| Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI) |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Efficacy Questionnaire for Children (SEQ-C) | Measures emotional self-efficacy (mean score) | Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment |
| Emotional Regulation Questionnaire for Children and Adolescents (ERQ-CA) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan L Ranney, MD MPH | Yale School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States | ||
| Rhode Island Hospital/Hasbro Children's Hospital |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003143 | Communication Devices for People with Disabilities |
| ID | Term |
|---|---|
| D012656 | Self-Help Devices |
| D004864 | Equipment and Supplies |
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| + Text | Behavioral | 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. |
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Change from enrollment other forms of peer violence (dating relationships) |
| 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) | 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) | Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment |
Measures cognitive reappraisal (score is summed, range 6 - 30) |
| Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment |
| Bosworth Violence Self-Efficacy Scale | Measures self-rated ability to stay out of violence (mean score) | Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment |
| Providence |
| Rhode Island |
| 02903 |
| United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |