Trial Outcomes & Findings for Intervention for Battered Sheltered Women With Substance Use Randomized Trial (NCT NCT02629133)
NCT ID: NCT02629133
Last Updated: 2020-04-08
Results Overview
The computer-based TLFB will assess drug use and heavy drinking (4+ standard drinks) days for the past week and the past 90 days. For primary analysis, days using drugs and heavy drinking days will be combined to create a single variable that reflects the total number of days that women used drugs or had 4+ drinks. The primary outcome is substance use (heavy drinking or drug using) days over a 6 month post shelter period. We are assessing the change of this number from baseline to 3 months post shelter, and from baseline 6 months post shelter.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Assessed at baseline, and at 3 and 6 months post shelter
Results posted on
2020-04-08
Participant Flow
Participant milestones
| Measure |
SHE Program
Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.
SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.
|
Control Condition
Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
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|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
SHE Program
Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.
SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.
|
Control Condition
Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
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|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
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1
|
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Overall Study
Withdrawal by Subject
|
1
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1
|
Baseline Characteristics
Intervention for Battered Sheltered Women With Substance Use Randomized Trial
Baseline characteristics by cohort
| Measure |
SHE Program
n=25 Participants
Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.
SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.
|
Control Condition
n=25 Participants
Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
|
Total
n=50 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
1 Participants
n=39 Participants
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0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
49 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 11.4 • n=39 Participants
|
35.2 years
STANDARD_DEVIATION 11.5 • n=41 Participants
|
35.2 years
STANDARD_DEVIATION 11.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
50 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
41 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=39 Participants
|
25 participants
n=41 Participants
|
50 participants
n=35 Participants
|
|
% drug using/heavy drinking days
|
0.54 % drug using/heavy drinking days
STANDARD_DEVIATION 0.38 • n=39 Participants
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0.66 % drug using/heavy drinking days
STANDARD_DEVIATION 0.38 • n=41 Participants
|
0.59 % drug using/heavy drinking days
STANDARD_DEVIATION 0.37 • n=35 Participants
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PRIMARY outcome
Timeframe: Assessed at baseline, and at 3 and 6 months post shelterThe computer-based TLFB will assess drug use and heavy drinking (4+ standard drinks) days for the past week and the past 90 days. For primary analysis, days using drugs and heavy drinking days will be combined to create a single variable that reflects the total number of days that women used drugs or had 4+ drinks. The primary outcome is substance use (heavy drinking or drug using) days over a 6 month post shelter period. We are assessing the change of this number from baseline to 3 months post shelter, and from baseline 6 months post shelter.
Outcome measures
| Measure |
SHE Program
n=25 Participants
Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.
SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.
|
Control Condition
n=25 Participants
Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
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|---|---|---|
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Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version
Baseline
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0.54 % days of drug use or heavy drinking
Standard Deviation 0.38
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0.66 % days of drug use or heavy drinking
Standard Deviation 0.38
|
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Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version
3 months post-shelter
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0.12 % days of drug use or heavy drinking
Standard Deviation 0.38
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0.29 % days of drug use or heavy drinking
Standard Deviation 0.38
|
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Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version
6 months post-shelter
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0.21 % days of drug use or heavy drinking
Standard Deviation 0.42
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0.16 % days of drug use or heavy drinking
Standard Deviation 0.21
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SECONDARY outcome
Timeframe: Assessed at baseline, and again at 3 and 6 months laterThe Treatment Services Review will be used to assess total times using substance use services (both treatment and self-help utilization) received (including outpatient, day patient, residential treatment, NA, AA) to capture the extent to which women are reaching out to access recovery-related resources. The TSR will assess number of times attending substance use services, divided by the number of days in the reporting period.
Outcome measures
| Measure |
SHE Program
n=25 Participants
Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.
SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.
|
Control Condition
n=25 Participants
Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
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|---|---|---|
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The Treatment Services Review (TSR)
Baseline
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0.00 times using substance use services/day
Standard Deviation 0.05
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0.01 times using substance use services/day
Standard Deviation 0.25
|
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The Treatment Services Review (TSR)
3 months post-shelter
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0.00 times using substance use services/day
Standard Deviation 0.23
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0.00 times using substance use services/day
Standard Deviation 0.22
|
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The Treatment Services Review (TSR)
6 months post-shelter
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0.00 times using substance use services/day
Standard Deviation 0.22
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0.00 times using substance use services/day
Standard Deviation 0.16
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SECONDARY outcome
Timeframe: Assessed at baseline, and again at 3 and 6 months after shelter releaseThe CAS is a widely used self-report of behaviors scale with 4 subscales that measure severe, combined abuse, emotional abuse, physical abuse, and harassment. The CAS has recently been published in the Centers for Disease Control and Prevention compendium of intimate partner violence measures. It consists of 30 items presented in a six point format requiring respondents to answer "never", "only once", "several times", "monthly", "weekly" or "daily" in a twelve month period. Below we present the CAS victimization scores. Scores range from 0 to 145; higher scores are worse.
Outcome measures
| Measure |
SHE Program
n=25 Participants
Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.
SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.
|
Control Condition
n=25 Participants
Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
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|---|---|---|
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The Composite Abuse Scale (CAS)
Baseline
|
52.8 score on a scale
Standard Deviation 22.6
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74.4 score on a scale
Standard Deviation 40.5
|
|
The Composite Abuse Scale (CAS)
3 months post-shelter
|
9.4 score on a scale
Standard Deviation 11.5
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17.7 score on a scale
Standard Deviation 32.8
|
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The Composite Abuse Scale (CAS)
6 months post-shelter
|
14.1 score on a scale
Standard Deviation 23.8
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4.9 score on a scale
Standard Deviation 10.6
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SECONDARY outcome
Timeframe: Assessed at baseline, and again at 3 and 6 months laterThe Cyber Stalking Scale measure is a 6 -item measure and assesses the use of technologies in stalking and harassment. Scores range from 0 to 12. Lower is better (indicated less Cyber Stalking).
Outcome measures
| Measure |
SHE Program
n=23 Participants
Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.
SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.
|
Control Condition
n=23 Participants
Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
|
|---|---|---|
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The Cyber Stalking Scale
Baseline
|
9.53 score on a scale
Standard Deviation 3.01
|
7.39 score on a scale
Standard Deviation 4.29
|
|
The Cyber Stalking Scale
3 months post-shelter
|
4.95 score on a scale
Standard Deviation 4.54
|
3.30 score on a scale
Standard Deviation 4.45
|
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The Cyber Stalking Scale
6 months post-shelter
|
3.89 score on a scale
Standard Deviation 4.27
|
2.00 score on a scale
Standard Deviation 3.23
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SECONDARY outcome
Timeframe: Assessed at baseline, and again at 3 and 6 months after shelter releaseSafety Behavior Checklist (SBC) has 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Scores range from 0 to 15; higher scores are better (indicating more safety behaviors used).
Outcome measures
| Measure |
SHE Program
n=25 Participants
Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.
SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.
|
Control Condition
n=25 Participants
Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
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|---|---|---|
|
Safety Behavior Checklist (SBC)
Baseline
|
7.3 score on a scale
Standard Deviation 2.7
|
7.3 score on a scale
Standard Deviation 4.0
|
|
Safety Behavior Checklist (SBC)
3 months post-shelter
|
4.5 score on a scale
Standard Deviation 3.4
|
5.7 score on a scale
Standard Deviation 4.9
|
|
Safety Behavior Checklist (SBC)
6 months post-shelter
|
2.8 score on a scale
Standard Deviation 3.8
|
4.9 score on a scale
Standard Deviation 5.3
|
Adverse Events
SHE Program
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Condition
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SHE Program
n=25 participants at risk
Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.
SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.
|
Control Condition
n=25 participants at risk
Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization-general medical issue
|
12.0%
3/25 • Number of events 3 • Adverse event data was collected from baseline to 6 months after the participant left the shelter--varies from 6 months to 1 1/2 years depending on the participant.
In addition, the DSMB also included possible partner violence due to a child welfare report made by study participant and/or study staff (if have children) during the duration of the study.
|
12.0%
3/25 • Number of events 3 • Adverse event data was collected from baseline to 6 months after the participant left the shelter--varies from 6 months to 1 1/2 years depending on the participant.
In addition, the DSMB also included possible partner violence due to a child welfare report made by study participant and/or study staff (if have children) during the duration of the study.
|
|
Injury, poisoning and procedural complications
Hospitalization-IPV related
|
16.0%
4/25 • Number of events 4 • Adverse event data was collected from baseline to 6 months after the participant left the shelter--varies from 6 months to 1 1/2 years depending on the participant.
In addition, the DSMB also included possible partner violence due to a child welfare report made by study participant and/or study staff (if have children) during the duration of the study.
|
28.0%
7/25 • Number of events 7 • Adverse event data was collected from baseline to 6 months after the participant left the shelter--varies from 6 months to 1 1/2 years depending on the participant.
In addition, the DSMB also included possible partner violence due to a child welfare report made by study participant and/or study staff (if have children) during the duration of the study.
|
|
Psychiatric disorders
Hospitalization-inpatient-psyc
|
20.0%
5/25 • Number of events 8 • Adverse event data was collected from baseline to 6 months after the participant left the shelter--varies from 6 months to 1 1/2 years depending on the participant.
In addition, the DSMB also included possible partner violence due to a child welfare report made by study participant and/or study staff (if have children) during the duration of the study.
|
20.0%
5/25 • Number of events 16 • Adverse event data was collected from baseline to 6 months after the participant left the shelter--varies from 6 months to 1 1/2 years depending on the participant.
In addition, the DSMB also included possible partner violence due to a child welfare report made by study participant and/or study staff (if have children) during the duration of the study.
|
|
Injury, poisoning and procedural complications
IPV-sought no medical care
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected from baseline to 6 months after the participant left the shelter--varies from 6 months to 1 1/2 years depending on the participant.
In addition, the DSMB also included possible partner violence due to a child welfare report made by study participant and/or study staff (if have children) during the duration of the study.
|
0.00%
0/25 • Adverse event data was collected from baseline to 6 months after the participant left the shelter--varies from 6 months to 1 1/2 years depending on the participant.
In addition, the DSMB also included possible partner violence due to a child welfare report made by study participant and/or study staff (if have children) during the duration of the study.
|
|
Injury, poisoning and procedural complications
IPV-emergency room visit only
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected from baseline to 6 months after the participant left the shelter--varies from 6 months to 1 1/2 years depending on the participant.
In addition, the DSMB also included possible partner violence due to a child welfare report made by study participant and/or study staff (if have children) during the duration of the study.
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected from baseline to 6 months after the participant left the shelter--varies from 6 months to 1 1/2 years depending on the participant.
In addition, the DSMB also included possible partner violence due to a child welfare report made by study participant and/or study staff (if have children) during the duration of the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place