Clinical trial NCT02370394: Intervention for IPV Perinatal Women- RCT
Official title: Computer-Based Intervention for Victimized Perinatal Women With Mental Illness (Phase 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Keywords: Intimate Partner Violence
Perinatal Women
Mental Health
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-02-24
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Composite Abuse Scale (CAS)-CAS Victimization Total Score
timeFrame: Assessed at baseline, and again three months later
measure: Safety Behavior Checklist (SBC)
timeFrame: Assessed at baseline, and again three months later
measure: Effectiveness in Obtaining Resources Scale (EOR)
timeFrame: Assessed at baseline, and again three months later
Secondary outcomes:
measure: Motivation Scale
timeFrame: Assessed at baseline, and again three months later
measure: The Readiness to Change Contemplation Ladder
timeFrame: Assessed at baseline, and again three months later
Other outcomes:
Locations:
city: Providence
country: United States
facility: Center for Women's Behavioral Health at Women and Infants' Hospital
state: Rhode Island
Study officials:
affiliation: Women and Infants' Hospital
name: Caron Zlotnick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.