- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02370394
Intervention for IPV Perinatal Women- RCT
Computer-Based Intervention for Victimized Perinatal Women With Mental Illness (Phase 1)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Center for Women's Behavioral Health at Women and Infants' Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant or postpartum women (up to 6 months after delivery)
- Age 18 or older
- Seeking mental health treatment at The Center for Women's Behavioral Health (WBH) at Women and Infants Hospital (WIH)
- Endorsed any IPV during the past 12 months as measured by the Woman Abuse Screening Tool (WAST)
Exclusion Criteria:
- Inability to provide informed consent (e.g., due to psychosis, intoxication, or other clear cognitive impairment)
- Inability to understand English (understand the consent form when read aloud and assessments that are narrated by computer)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ROSE Program
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.
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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.
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No Intervention: Control Condition
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite Abuse Scale (CAS)-CAS Victimization Total Score
Time Frame: Assessed at baseline, and again three months later
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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.
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Assessed at baseline, and again three months later
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Safety Behavior Checklist (SBC)
Time Frame: Assessed at baseline, and again three months later
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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.
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Assessed at baseline, and again three months later
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Effectiveness in Obtaining Resources Scale (EOR)
Time Frame: Assessed at baseline, and again three months later
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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.
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Assessed at baseline, and again three months later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation Scale
Time Frame: Assessed at baseline, and again three months later
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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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Assessed at baseline, and again three months later
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The Readiness to Change Contemplation Ladder
Time Frame: Assessed at baseline, and again three months later
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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.
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Assessed at baseline, and again three months later
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 14-0056
- 1R21HD077358-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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