Intervention for IPV Perinatal Women- RCT

Intimate Partner Violence Clinical Trial

Official title:

Computer-Based Intervention for Victimized Perinatal Women With Mental Illness (Phase 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370394
• Other study ID #: 14-0056
• Secondary ID: 1R21HD077358-01A
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: May 2018
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Intimate Partner Violence

Intervention

Behavioral:
• 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 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.

Locations

Country	Name	City	State
United States	Center for Women's Behavioral Health at Women and Infants' Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Assessed at baseline, and again three 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.	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.	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.	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.	Assessed at baseline, and again three months later