Trial Outcomes & Findings for Intervention for IPV Perinatal Women- RCT (NCT NCT02370394)
NCT ID: NCT02370394
Last Updated: 2018-06-04
Results Overview
A widely used self-report of behaviors that includes a 36-item scale - only the CAS Victimization Total score was calculated. Items were scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-180. Mean score was used to calculate differences between baseline and follow-up and between groups. The lower the score, the better or less victimization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
Assessed at baseline, and again three months later
Results posted on
2018-06-04
Participant Flow
We recruited perinatal women from The Center for Women's Behavioral Health (WBH) at Women and Infants Hospital (WIH) between May 2015 and April 2016.
Participant milestones
| Measure |
ROSE Program
Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.
ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.
|
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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
25
|
|
Overall Study
COMPLETED
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
ROSE Program
Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.
ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.
|
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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Intervention for IPV Perinatal Women- RCT
Baseline characteristics by cohort
| Measure |
ROSE Program
n=28 Participants
Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.
ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.
|
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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.03 years
n=5 Participants
|
28.32 years
n=7 Participants
|
27.64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline, and again three months laterPopulation: The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.
A widely used self-report of behaviors that includes a 36-item scale - only the CAS Victimization Total score was calculated. Items were scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-180. Mean score was used to calculate differences between baseline and follow-up and between groups. The lower the score, the better or less victimization.
Outcome measures
| Measure |
ROSE Program
n=28 Participants
Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.
ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.
|
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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
|
|---|---|---|
|
Composite Abuse Scale (CAS)-CAS Victimization Total Score
CAS at Baseline
|
26.36 units on a scale
Standard Deviation 17.81
|
16.56 units on a scale
Standard Deviation 12.25
|
|
Composite Abuse Scale (CAS)-CAS Victimization Total Score
CAS at Follow-up
|
12.38 units on a scale
Standard Deviation 12.44
|
16.52 units on a scale
Standard Deviation 20.23
|
PRIMARY outcome
Timeframe: Assessed at baseline, and again three months laterPopulation: The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.
Includes 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Items were scored as Yes=1 or No=0 or Not applicable. Scale range is from 0-15. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more use of safety behaviors.
Outcome measures
| Measure |
ROSE Program
n=28 Participants
Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.
ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.
|
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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
|
|---|---|---|
|
Safety Behavior Checklist (SBC)
SBC at Baseline
|
.28 units on a scale
Standard Deviation .23
|
.36 units on a scale
Standard Deviation .23
|
|
Safety Behavior Checklist (SBC)
SBC at Follow Up
|
.28 units on a scale
Standard Deviation .28
|
.32 units on a scale
Standard Deviation .29
|
PRIMARY outcome
Timeframe: Assessed at baseline, and again three months laterPopulation: The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.
Assesses the women's effectiveness in obtaining resources from 11 different types of community resources including mental health treatment, church or clergy, health care, legal services, police, or social services. Items were scored as Yes=1 or No=0. Scale range is from 0-11. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more they were effective in obtaining resources.
Outcome measures
| Measure |
ROSE Program
n=28 Participants
Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.
ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.
|
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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
|
|---|---|---|
|
Effectiveness in Obtaining Resources Scale (EOR)
EOR at Baseline
|
2.46 units on a scale
Standard Deviation 1.71
|
3.48 units on a scale
Standard Deviation 2.87
|
|
Effectiveness in Obtaining Resources Scale (EOR)
EOR at Follow Up
|
3.31 units on a scale
Standard Deviation 2.59
|
3.43 units on a scale
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: Assessed at baseline, and again three months laterPopulation: The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.
A 1-item measure, was modified to assess how ready they are to use treatment, resources, and/or support for any partner abuse. This item was scored with a range from 0-10. 0=not ready at all to 10=completely ready. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to use treatment, resources, or support for any partner abuse.
Outcome measures
| Measure |
ROSE Program
n=28 Participants
Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.
ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.
|
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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
|
|---|---|---|
|
Motivation Scale
Motivation Scale at Baseline
|
6.18 units on a scale
Standard Deviation 2.76
|
7.52 units on a scale
Standard Deviation 3.48
|
|
Motivation Scale
Motivation Scale at Follow Up
|
6.81 units on a scale
Standard Deviation 3.64
|
7.22 units on a scale
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: Assessed at baseline, and again three months laterPopulation: The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.
One item measure to assess readiness to make changes to increase safety. This item was scored with a range from 0-10. 0=not prepared to change to 10=already changing. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to make changes to increase safety.
Outcome measures
| Measure |
ROSE Program
n=28 Participants
Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.
ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.
|
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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
|
|---|---|---|
|
The Readiness to Change Contemplation Ladder
Readiness at Baseline
|
8.25 units on a scale
Standard Deviation 2.01
|
8.08 units on a scale
Standard Deviation 2.68
|
|
The Readiness to Change Contemplation Ladder
Readiness at Follow Up
|
8.00 units on a scale
Standard Deviation 2.94
|
7.26 units on a scale
Standard Deviation 2.97
|
Adverse Events
ROSE Program
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Condition
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ROSE Program
n=28 participants at risk
Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.
ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.
|
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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization-general medical issue
|
14.3%
4/28 • Number of events 4 • Adverse event data were collected between the date of the baseline and the 3 month follow-up, generally for 3 months, depending on when the participant's 3 month follow-up actually occurred.
The DSMB decided that the following would be included as SAEs: any serious/life threatening threats of intimate partner violence, rape, sexual assault, emergency room visits as well as death, hospitalization, and life-threatening events, as described in the clinicaltrials.gov definitions.
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected between the date of the baseline and the 3 month follow-up, generally for 3 months, depending on when the participant's 3 month follow-up actually occurred.
The DSMB decided that the following would be included as SAEs: any serious/life threatening threats of intimate partner violence, rape, sexual assault, emergency room visits as well as death, hospitalization, and life-threatening events, as described in the clinicaltrials.gov definitions.
|
|
Psychiatric disorders
Hospitalization-inpatient-psyc
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected between the date of the baseline and the 3 month follow-up, generally for 3 months, depending on when the participant's 3 month follow-up actually occurred.
The DSMB decided that the following would be included as SAEs: any serious/life threatening threats of intimate partner violence, rape, sexual assault, emergency room visits as well as death, hospitalization, and life-threatening events, as described in the clinicaltrials.gov definitions.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected between the date of the baseline and the 3 month follow-up, generally for 3 months, depending on when the participant's 3 month follow-up actually occurred.
The DSMB decided that the following would be included as SAEs: any serious/life threatening threats of intimate partner violence, rape, sexual assault, emergency room visits as well as death, hospitalization, and life-threatening events, as described in the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
IPV-no medical care
|
0.00%
0/28 • Adverse event data were collected between the date of the baseline and the 3 month follow-up, generally for 3 months, depending on when the participant's 3 month follow-up actually occurred.
The DSMB decided that the following would be included as SAEs: any serious/life threatening threats of intimate partner violence, rape, sexual assault, emergency room visits as well as death, hospitalization, and life-threatening events, as described in the clinicaltrials.gov definitions.
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected between the date of the baseline and the 3 month follow-up, generally for 3 months, depending on when the participant's 3 month follow-up actually occurred.
The DSMB decided that the following would be included as SAEs: any serious/life threatening threats of intimate partner violence, rape, sexual assault, emergency room visits as well as death, hospitalization, and life-threatening events, as described in the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
IPV related emergency room visit
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected between the date of the baseline and the 3 month follow-up, generally for 3 months, depending on when the participant's 3 month follow-up actually occurred.
The DSMB decided that the following would be included as SAEs: any serious/life threatening threats of intimate partner violence, rape, sexual assault, emergency room visits as well as death, hospitalization, and life-threatening events, as described in the clinicaltrials.gov definitions.
|
0.00%
0/25 • Adverse event data were collected between the date of the baseline and the 3 month follow-up, generally for 3 months, depending on when the participant's 3 month follow-up actually occurred.
The DSMB decided that the following would be included as SAEs: any serious/life threatening threats of intimate partner violence, rape, sexual assault, emergency room visits as well as death, hospitalization, and life-threatening events, as described in the clinicaltrials.gov definitions.
|
Other adverse events
Adverse event data not reported
Additional Information
Caron Zlotnick, Ph.D.
Butler Hospital/Women and Infants Hospital
Phone: (401) 455-6529
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place