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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD077358-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The study developed and assessed an innovative, high-reach, easily implementable, low-cost computer-delivered intervention (Reach out for a Safe Environment; ROSE Program) that addressed known barriers in early identification and intervention with perinatal women with IPV seeking treatment for mental illness.
Intimate partner violence (IPV) is a significant social and public health problem among perinatal women. Research suggests that from 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, IPV places a woman at high risk for several psychiatric disorders, which transforms the perinatal period from an already challenging process into a potentially overwhelming one. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. Experts in the field advocate for more IPV screening and intervention to take place among women who are at high-risk for IPV. Given the high rates of IPV among women who seek mental health treatment, mental health clinics compared to other medical settings (e.g. primary care) are more effective sites for focused case finding and intervention. Further, the presence of IPV increases the likelihood of disengagement from treatment, which could compromise the ability of women with IPV to effectively use important shelter and community resources necessary for establishing safety for themselves and their children. A timely intervention might reduce the risk of future IPV, improve treatment utilization, and reduce mental health symptoms. A brief intervention that is designed specifically for the unique needs of perinatal women with IPV seeking mental health treatment provides a tremendous opportunity to intervene with a group of women who are particularly vulnerable and who might be unusually open to making changes to their lives.
This study is the first step towards developing a computer-based brief intervention ("Reach Out for a Safe Environment") that targets intimate partner violence in perinatal women in mental health treatment and constitutes the developmental aims of a larger study. The aims were to perform a small open trial (n = 8) of the Reach Out for a Safe Environment (ROSE) intervention to assess feasibility of recruitment of target population and acceptability of intervention and study procedures. Also, to conduct a randomized controlled pilot study in a sample of 50 perinatal women seeking mental health treatment who screen positive for recent IPV to demonstrate the acceptability and feasibility of the ROSE intervention via participant report of ease of use, helpfulness, and overall satisfaction.
We collected several measures on the feasibility of the research design, the acceptability of ROSE, and on intervention effects for IPV severity and level of self-care strategies (primary outcomes), motivation and self efficacy (secondary outcomes), and use of recommended mental health treatment services (tertiary outcome). This phase used a two-group, randomized, controlled design with an initial session for both conditions plus booster session one month later for the intervention condition. The initial intervention session was conducted close to an intake visit for mental health difficulties, with a booster session within one month following baseline. There was a 3-month follow up assessment. Assessments and the booster session were conducted in a private room or at a location that was a convenient location for the woman and one that provided a confidential, safe, and comfortable environment for the participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROSE Program | Experimental | Participants received a 35-40-minute intervention on the Tablet PC and an in-person 10-15-minute booster session conducted by interventionists within a month after the intervention. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later. |
|
| Control Condition | No Intervention | Control Condition consisted of a series of questions regarding television show preferences and then viewed 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROSE Program | Behavioral | 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 tailored to 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Abuse Scale (CAS)-CAS Victimization Total Score | 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. | Assessed at baseline, and again three months later |
| Safety Behavior Checklist (SBC) | 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. | Assessed at baseline, and again three months later |
| Effectiveness in Obtaining Resources Scale (EOR) | 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. | Assessed at baseline, and again three months later |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation Scale | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caron Zlotnick, PhD | Women and Infants' Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Women's Behavioral Health at Women and Infants' Hospital | Providence | Rhode Island | 02905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32608505 | Derived | Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2. | |
| 30088145 | Derived | Zlotnick C, Tzilos Wernette G, Raker CA. A randomized controlled trial of a computer-based brief intervention for victimized perinatal women seeking mental health treatment. Arch Womens Ment Health. 2019 Jun;22(3):315-325. doi: 10.1007/s00737-018-0895-1. Epub 2018 Aug 7. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Abuse Scale (CAS)-CAS Victimization Total Score | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed at baseline, and again three months later |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization-general medical issue | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caron Zlotnick, Ph.D. | Butler Hospital/Women and Infants Hospital | (401) 455-6529 | CZlotnick@Butler.org |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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|
| Assessed at baseline, and again three months later |
| The Readiness to Change Contemplation Ladder | 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. | Assessed at baseline, and again three months later |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Primary | Safety Behavior Checklist (SBC) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed at baseline, and again three months later |
|
|
|
|
| Primary | Effectiveness in Obtaining Resources Scale (EOR) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed at baseline, and again three months later |
|
|
|
|
| Secondary | Motivation Scale | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed at baseline, and again three months later |
|
|
|
|
| Secondary | The Readiness to Change Contemplation Ladder | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed at baseline, and again three months later |
|
|
|
|
| 0 |
| 28 |
| 9 |
| 28 |
| 0 |
| 28 |
| EG001 | 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. | 0 | 25 | 6 | 25 | 0 | 25 |
| Hospitalization-inpatient-psyc | Psychiatric disorders | Non-systematic Assessment |
|
| IPV-no medical care | Injury, poisoning and procedural complications | Non-systematic Assessment | Physical abuse or rape - no medical care sought for injuries |
|
| IPV related emergency room visit | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| SBC at Follow Up |
|
|
| t-test, 2 sided |
| 0.9116 |
| Mean Difference (Net) |
| -0.01 |
| 2-Sided |
| 95 |
| -0.16 |
| 0.15 |
| Superiority |
| EOR at Follow Up |
|
|
Change in Number of Issues Effective at Accomplishing from Baseline to Follow Up
| t-test, 2 sided |
| 0.3045 |
| Mean Difference (Net) |
| -0.86 |
| 2-Sided |
| 95 |
| -2.54 |
| 0.82 |
| Superiority |
| Motivation Scale at Follow Up |
|
|
| 0.3256 |
| Superiority |
| Readiness at Follow Up |
|
|
| 0.2467 |
| Superiority |