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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH095866 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute of Mental Health (NIMH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iDOVE Intervention (ED+text) | Experimental |
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| Control (EUC) | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iDOVE Intervention (ED+text) | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Acceptability/Feasibility: Engagement of Intervention Group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Ranney, MD MPH | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital Emergency Department | Providence | Rhode Island | 02903 | United States |
Less than 150 randomized controlled trial (RCT) participants
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Of 1,190 potential screening subjects presenting to the ED for any reason during from February-December 2015, 1063 consented to screening. Of these, 1031 were successfully screened and 142 met eligibility criteria for the full trial. Of those eligible for the full randomized controlled trial (RCT), 116 consented.
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| ID | Title | Description |
|---|---|---|
| FG000 | iDOVE Intervention (ED+Text) |
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 |
| FG001 | Control (EUC) |
Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | iDOVE Intervention (ED+Text) |
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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Stratified by baseline "moderate depressive symptoms" (BDI>=20). | Posted | Mean | Standard Deviation | units on a scale | Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention) |
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Adverse events were monitored through study completion (2 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iDOVE Intervention (ED+Text) |
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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan L. Ranney, MD, MPH, FACEP | Department of Emergency Medicine, Alpert Medical School, Brown University | 401-444-2557 | megan_ranney@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2015 | Jul 11, 2017 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2015 | Sep 22, 2017 | Prot_SAP_001.pdf |
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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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| Control (EUC) | Behavioral |
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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 |
| 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) |
| BG001 | Control (EUC) |
Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| School Year | Count of Participants | Participants |
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| Socio-economic status | Socioeconomic Status (SES) was collected using selected items from the National Study for Adolescent Health. "Low" SES was defined as receipt of free services (a parent or guardian who qualifies for public assistance, welfare, food stamps, disability benefits, Medicaid, Rite-care, etc., or a child who qualifies for free or reduced lunches from school). "High" SES was defined as not receiving free services. | Count of Participants | Participants |
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| Sexual Orientation | Count of Participants | Participants |
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| The Revised Conflict Tactics Scales (CTS-2) | 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). | Mean | Standard Deviation | units on a scale |
|
| The Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression based on diagnostic criteria of depression from the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV. It asks about the patient's experience in the last 2 weeks. Responses range from "0" (Not at all) to "3" (nearly every day). The total sum of the responses suggests varying levels of depression. Scores range from 0 to 27. A total of 10 or above is suggestive of the presence of depression. | Mean | Standard Deviation | units on a scale |
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| The Beck Depression Inventory (BDI-2) | The Beck Depression Inventory (BDI-2) is a 1996 revision of the BDI, developed in response to the 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. | Mean | Standard Deviation | units on a scale |
|
| OG000 | iDOVE Intervention (ED+Text) |
iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program |
| OG001 | Control (EUC) |
Control (Enhanced Usual Care (EUC)): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program |
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| 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). | Stratified by higher baseline violence (CTS score >=4) | Posted | Median | Full Range | units on a scale | Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention) |
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| Secondary | Acceptability/Feasibility: Follow Up Rate | Retention Rate: % of consented participants who completed follow up | Posted | Count of Participants | Participants | 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention) |
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| 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. | Posted | Count of Participants | Participants | Enrollment to 16 weeks post-enrollment |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks post-enrollment (close of intervention) |
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| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Control (EUC) |
Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program | 0 | 58 | 0 | 58 | 0 | 58 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| CTS Score: 8 week |
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| CTS Score: 16 week |
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| CTS Score where baseline >=4: Baseline |
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| CTS Score where baseline >=4: 8 week |
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| CTS Score where baseline >=4: 16 week |
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