Depressive Disorder, Violence
Conditions
Keywords
depression, violence, emergency department, mhealth, text message
Brief 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.
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.
Interventions
BEHAVIORALiDOVE 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
BEHAVIORALControl (EUC)
1. In-ED brief session, discussing home safety & nutrition 2. Eight-week longitudinal home safety & nutrition text-message program
Sponsors
National Institute of Mental Health (NIMH)
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability/Feasibility: Follow Up Rate | 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention) | Retention Rate: % of consented participants who completed follow up |
| Acceptability/Feasibility: Engagement of Intervention Group | Enrollment to 16 weeks post-enrollment | 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. |
| Acceptability/Feasibility: Participant Satisfaction | 8 weeks post-enrollment (close of intervention) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 58 |
| Control (EUC) 1. In-ED brief session, discussing home safety & nutrition
2. Eight-week longitudinal home safety & nutrition text-message program
Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program | 58 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 6 |
Baseline characteristics
| Characteristic | Total | iDOVE Intervention (ED+Text) | Control (EUC) |
|---|---|---|---|
| Age, Continuous | 14.94 years STANDARD_DEVIATION 1.18 | 14.83 years STANDARD_DEVIATION 1.23 | 15.05 years STANDARD_DEVIATION 1.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 41 Participants | 18 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 39 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 17 Participants | 8 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 26 Participants | 12 Participants | 14 Participants |
| Race (NIH/OMB) White | 57 Participants | 29 Participants | 28 Participants |
| Region of Enrollment United States | 116 participants | 58 participants | 58 participants |
| School Year College | 2 Participants | 2 Participants | 0 Participants |
| School Year Grades 6-8 | 26 Participants | 16 Participants | 10 Participants |
| School Year Grades 9-12 | 85 Participants | 37 Participants | 48 Participants |
| School Year Not in school | 3 Participants | 3 Participants | 0 Participants |
| Sex/Gender, Customized Gender Female | 68 Participants | 34 Participants | 34 Participants |
| Sex/Gender, Customized Gender Male | 46 Participants | 24 Participants | 22 Participants |
| Sex/Gender, Customized Gender Transgender, Other, Prefer not to answer | 2 Participants | 0 Participants | 2 Participants |
| Sexual Orientation LGBQ | 21 Participants | 11 Participants | 10 Participants |
| Sexual Orientation Prefer not to answer | 6 Participants | 4 Participants | 2 Participants |
| Sexual Orientation Straight | 89 Participants | 43 Participants | 46 Participants |
| Socio-economic status High SES | 34 Participants | 20 Participants | 14 Participants |
| Socio-economic status Low SES | 78 Participants | 36 Participants | 42 Participants |
| Socio-economic status Prefer not to answer | 4 Participants | 2 Participants | 2 Participants |
| The Beck Depression Inventory (BDI-2) | 13.51 units on a scale STANDARD_DEVIATION 9.33 | 13.60 units on a scale STANDARD_DEVIATION 8.59 | 13.41 units on a scale STANDARD_DEVIATION 10.1 |
| The Patient Health Questionnaire (PHQ-9) | 9.10 units on a scale STANDARD_DEVIATION 3.66 | 9.43 units on a scale STANDARD_DEVIATION 3.82 | 8.78 units on a scale STANDARD_DEVIATION 3.49 |
| The Revised Conflict Tactics Scales (CTS-2) | 3.88 units on a scale STANDARD_DEVIATION 5.22 | 5.07 units on a scale STANDARD_DEVIATION 6.72 | 2.69 units on a scale STANDARD_DEVIATION 2.64 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 58 |
| other Total, other adverse events | 0 / 58 | 0 / 58 |
| serious Total, serious adverse events | 0 / 58 | 0 / 58 |
Outcome results
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.
Time frame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
Population: Stratified by baseline moderate depressive symptoms (BDI\>=20).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iDOVE Intervention (ED+Text) | Change in Depressive Symptoms | BDI Score: Baseline | 13.6 units on a scale | Standard Deviation 8.6 |
| iDOVE Intervention (ED+Text) | Change in Depressive Symptoms | BDI Score: 8 week | 14.8 units on a scale | Standard Deviation 12.4 |
| iDOVE Intervention (ED+Text) | Change in Depressive Symptoms | BDI Score: 16 week | 12.5 units on a scale | Standard Deviation 12.8 |
| iDOVE Intervention (ED+Text) | Change in Depressive Symptoms | BDI Score where baseline >=20: Baseline | 24.5 units on a scale | Standard Deviation 4.2 |
| iDOVE Intervention (ED+Text) | Change in Depressive Symptoms | BDI Score where baseline >=20: 8 week | 19.9 units on a scale | Standard Deviation 12.1 |
| iDOVE Intervention (ED+Text) | Change in Depressive Symptoms | BDI Score where baseline >=20: 16 week | 21.9 units on a scale | Standard Deviation 14.9 |
| Control (EUC) | Change in Depressive Symptoms | BDI Score where baseline >=20: 8 week | 27.2 units on a scale | Standard Deviation 11.5 |
| Control (EUC) | Change in Depressive Symptoms | BDI Score: Baseline | 13.4 units on a scale | Standard Deviation 10.1 |
| Control (EUC) | Change in Depressive Symptoms | BDI Score where baseline >=20: Baseline | 27.9 units on a scale | Standard Deviation 9.2 |
| Control (EUC) | Change in Depressive Symptoms | BDI Score: 8 week | 15.0 units on a scale | Standard Deviation 11.9 |
| Control (EUC) | Change in Depressive Symptoms | BDI Score where baseline >=20: 16 week | 25.2 units on a scale | Standard Deviation 10 |
| Control (EUC) | Change in Depressive Symptoms | BDI Score: 16 week | 11.7 units on a scale | Standard Deviation 11 |
Comparison: BDI Score where baseline \>=20: 8 weekp-value: 0.07Mixed effects longitudinal regression
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).
Time frame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
Population: Stratified by higher baseline violence (CTS score \>=4)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| iDOVE Intervention (ED+Text) | Change in Peer Violence Involvement | CTS Score: Baseline | 3.0 units on a scale |
| iDOVE Intervention (ED+Text) | Change in Peer Violence Involvement | CTS Score: 8 week | 2.5 units on a scale |
| iDOVE Intervention (ED+Text) | Change in Peer Violence Involvement | CTS Score: 16 week | 2.0 units on a scale |
| iDOVE Intervention (ED+Text) | Change in Peer Violence Involvement | CTS Score where baseline >=4: Baseline | 8.0 units on a scale |
| iDOVE Intervention (ED+Text) | Change in Peer Violence Involvement | CTS Score where baseline >=4: 8 week | 4.0 units on a scale |
| iDOVE Intervention (ED+Text) | Change in Peer Violence Involvement | CTS Score where baseline >=4: 16 week | 2.0 units on a scale |
| Control (EUC) | Change in Peer Violence Involvement | CTS Score where baseline >=4: 8 week | 4.0 units on a scale |
| Control (EUC) | Change in Peer Violence Involvement | CTS Score: Baseline | 2.0 units on a scale |
| Control (EUC) | Change in Peer Violence Involvement | CTS Score where baseline >=4: Baseline | 6.5 units on a scale |
| Control (EUC) | Change in Peer Violence Involvement | CTS Score: 8 week | 3.0 units on a scale |
| Control (EUC) | Change in Peer Violence Involvement | CTS Score where baseline >=4: 16 week | 5.0 units on a scale |
| Control (EUC) | Change in Peer Violence Involvement | CTS Score: 16 week | 1.0 units on a scale |
Comparison: CTS Score where baseline \>=4: 8 weekp-value: 0.01quantile regression models
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.
Time frame: Enrollment to 16 weeks post-enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| iDOVE Intervention (ED+Text) | Acceptability/Feasibility: Engagement of Intervention Group | Responded to >=1 of the daily mood queries | 56 Participants |
| iDOVE Intervention (ED+Text) | Acceptability/Feasibility: Engagement of Intervention Group | Requested on-demand support text-messages | 22 Participants |
Secondary
Acceptability/Feasibility: Follow Up Rate
Retention Rate: % of consented participants who completed follow up
Time frame: 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| iDOVE Intervention (ED+Text) | Acceptability/Feasibility: Follow Up Rate | 8 week follow up | 55 Participants |
| iDOVE Intervention (ED+Text) | Acceptability/Feasibility: Follow Up Rate | 16 week follow up | 54 Participants |
| Control (EUC) | Acceptability/Feasibility: Follow Up Rate | 8 week follow up | 55 Participants |
| Control (EUC) | Acceptability/Feasibility: Follow Up Rate | 16 week follow up | 52 Participants |
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.
Time frame: 8 weeks post-enrollment (close of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iDOVE Intervention (ED+Text) | Acceptability/Feasibility: Participant Satisfaction | 32.3 units on a scale | Standard Deviation 5.7 |
| Control (EUC) | Acceptability/Feasibility: Participant Satisfaction | 31.2 units on a scale | Standard Deviation 5.5 |
p-value: 0.33t-test, 2 sided