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Text-Message-Based Depression Prevention for High-Risk Youth in the ED (iDOVE)

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ClinicalTrials.gov Identifier: NCT02332239
Recruitment Status : Completed
First Posted : January 6, 2015
Results First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rhode Island Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Depressive Disorder
Violence
Interventions Behavioral: iDOVE Intervention (ED+text)
Behavioral: Control (EUC)
Enrollment 116
Recruitment Details  
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.
Arm/Group Title iDOVE Intervention (ED+Text) Control (EUC)
Hide Arm/Group Description
  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

  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

Period Title: Overall Study
Started 58 58
Completed 54 52
Not Completed 4 6
Reason Not Completed
Lost to Follow-up             4             6
Arm/Group Title iDOVE Intervention (ED+Text) Control (EUC) Total
Hide Arm/Group Description
  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

  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

Total of all reporting groups
Overall Number of Baseline Participants 58 58 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 58 participants 116 participants
14.83  (1.23) 15.05  (1.13) 14.94  (1.18)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Gender Number Analyzed 58 participants 58 participants 116 participants
Female
34
  58.6%
34
  58.6%
68
  58.6%
Male
24
  41.4%
22
  37.9%
46
  39.7%
Transgender, Other, Prefer not to answer
0
   0.0%
2
   3.4%
2
   1.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 116 participants
Hispanic or Latino
18
  31.0%
23
  39.7%
41
  35.3%
Not Hispanic or Latino
39
  67.2%
35
  60.3%
74
  63.8%
Unknown or Not Reported
1
   1.7%
0
   0.0%
1
   0.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 116 participants
American Indian or Alaska Native
2
   3.4%
1
   1.7%
3
   2.6%
Asian
1
   1.7%
3
   5.2%
4
   3.4%
Native Hawaiian or Other Pacific Islander
1
   1.7%
1
   1.7%
2
   1.7%
Black or African American
5
   8.6%
2
   3.4%
7
   6.0%
White
29
  50.0%
28
  48.3%
57
  49.1%
More than one race
8
  13.8%
9
  15.5%
17
  14.7%
Unknown or Not Reported
12
  20.7%
14
  24.1%
26
  22.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants 58 participants 116 participants
58 58 116
School Year  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 116 participants
Grades 6-8
16
  27.6%
10
  17.2%
26
  22.4%
Grades 9-12
37
  63.8%
48
  82.8%
85
  73.3%
College
2
   3.4%
0
   0.0%
2
   1.7%
Not in school
3
   5.2%
0
   0.0%
3
   2.6%
Socio-economic status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 116 participants
Low SES
36
  62.1%
42
  72.4%
78
  67.2%
High SES
20
  34.5%
14
  24.1%
34
  29.3%
Prefer not to answer
2
   3.4%
2
   3.4%
4
   3.4%
[1]
Measure Description: 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.
Sexual Orientation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 116 participants
Straight
43
  74.1%
46
  79.3%
89
  76.7%
LGBQ
11
  19.0%
10
  17.2%
21
  18.1%
Prefer not to answer
4
   6.9%
2
   3.4%
6
   5.2%
The Revised Conflict Tactics Scales (CTS-2)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 58 participants 58 participants 116 participants
5.07  (6.72) 2.69  (2.64) 3.88  (5.22)
[1]
Measure Description: 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).
The Patient Health Questionnaire (PHQ-9)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 58 participants 58 participants 116 participants
9.43  (3.82) 8.78  (3.49) 9.10  (3.66)
[1]
Measure Description: 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.
The Beck Depression Inventory (BDI-2)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 58 participants 58 participants 116 participants
13.60  (8.59) 13.41  (10.10) 13.51  (9.33)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change in Depressive Symptoms
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Stratified by baseline "moderate depressive symptoms" (BDI>=20).
Arm/Group Title iDOVE Intervention (ED+Text) Control (EUC)
Hide Arm/Group Description:
  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 CBT-based text-message program

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

  1. In-ED brief session, discussing home safety & nutrition
  2. Eight-week longitudinal home safety & nutrition text-message program

Control (Enhanced Usual Care (EUC)): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program

Overall Number of Participants Analyzed 58 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
BDI Score: Baseline Number Analyzed 58 participants 58 participants
13.6  (8.6) 13.4  (10.1)
BDI Score: 8 week Number Analyzed 58 participants 58 participants
14.8  (12.4) 15.0  (11.9)
BDI Score: 16 week Number Analyzed 58 participants 58 participants
12.5  (12.8) 11.7  (11.0)
BDI Score where baseline >=20: Baseline Number Analyzed 16 participants 15 participants
24.5  (4.2) 27.9  (9.2)
BDI Score where baseline >=20: 8 week Number Analyzed 16 participants 15 participants
19.9  (12.1) 27.2  (11.5)
BDI Score where baseline >=20: 16 week Number Analyzed 16 participants 15 participants
21.9  (14.9) 25.2  (10.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iDOVE Intervention (ED+Text), Control (EUC)
Comments BDI Score where baseline >=20: 8 week
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Mixed effects longitudinal regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.11
Estimation Comments d=0.37
2.Primary Outcome
Title Change in Peer Violence Involvement
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Stratified by higher baseline violence (CTS score >=4)
Arm/Group Title iDOVE Intervention (ED+Text) Control (EUC)
Hide Arm/Group Description:
  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

  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

Overall Number of Participants Analyzed 58 58
Median (Full Range)
Unit of Measure: units on a scale
CTS Score: Baseline Number Analyzed 58 participants 58 participants
3.0
(0.0 to 36.0)
2.0
(0.0 to 9.0)
CTS Score: 8 week Number Analyzed 58 participants 58 participants
2.5
(0.0 to 29.0)
3.0
(0.0 to 15.0)
CTS Score: 16 week Number Analyzed 58 participants 58 participants
2.0
(0.0 to 29.0)
1.0
(0.0 to 32.0)
CTS Score where baseline >=4: Baseline Number Analyzed 24 participants 18 participants
8.0
(0.0 to 32.0)
6.5
(0.0 to 15.0)
CTS Score where baseline >=4: 8 week Number Analyzed 24 participants 18 participants
4.0
(0.0 to 27.0)
4.0
(0.0 to 14.0)
CTS Score where baseline >=4: 16 week Number Analyzed 24 participants 18 participants
2.0
(0.0 to 29.0)
5.0
(0.0 to 32.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iDOVE Intervention (ED+Text), Control (EUC)
Comments CTS Score where baseline >=4: 8 week
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method quantile regression models
Comments Controlled for baseline and gender
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -7.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.62
Estimation Comments d=0.46
3.Secondary Outcome
Title Acceptability/Feasibility: Follow Up Rate
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iDOVE Intervention (ED+Text) Control (EUC)
Hide Arm/Group Description:
  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

  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

Overall Number of Participants Analyzed 58 58
Measure Type: Count of Participants
Unit of Measure: Participants
8 week follow up
55
  94.8%
55
  94.8%
16 week follow up
54
  93.1%
52
  89.7%
4.Secondary Outcome
Title Acceptability/Feasibility: Engagement of Intervention Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iDOVE Intervention (ED+Text)
Hide Arm/Group Description:
  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

Overall Number of Participants Analyzed 58
Measure Type: Count of Participants
Unit of Measure: Participants
Responded to >=1 of the daily mood queries
56
  96.6%
Requested on-demand support text-messages
22
  37.9%
5.Secondary Outcome
Title Acceptability/Feasibility: Participant Satisfaction
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iDOVE Intervention (ED+Text) Control (EUC)
Hide Arm/Group Description:
  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

  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

Overall Number of Participants Analyzed 58 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
32.3  (5.7) 31.2  (5.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iDOVE Intervention (ED+Text), Control (EUC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse events were not collected in this study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title iDOVE Intervention (ED+Text) Control (EUC)
Hide Arm/Group Description
  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

  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

All-Cause Mortality
iDOVE Intervention (ED+Text) Control (EUC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
iDOVE Intervention (ED+Text) Control (EUC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
iDOVE Intervention (ED+Text) Control (EUC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
  1. This study was not adequately powered to show efficacy.
  2. This study enrolled during a convenience sample of shifts, at a single ED, excluding non-English-speaking adolescents; these limitations may introduce bias or reduce generalizability.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Megan L. Ranney, MD, MPH, FACEP
Organization: Department of Emergency Medicine, Alpert Medical School, Brown University
Phone: 401-444-2557
Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT02332239     History of Changes
Other Study ID Numbers: K23MH095866 ( U.S. NIH Grant/Contract )
K23MH095866 ( U.S. NIH Grant/Contract )
First Submitted: December 29, 2014
First Posted: January 6, 2015
Results First Submitted: August 8, 2017
Results First Posted: December 7, 2017
Last Update Posted: December 7, 2017