Computerized Intervention for Reducing Intimate Partner Violence for Perinatal Women Seeking Mental Health Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- IPV
- Sponsor
- Women and Infants Hospital of Rhode Island
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Composite Abuse Scale (CAS)
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
The objective of this study is to test whether the innovative intervention, "Strength for U in Relationship Empowerment" (SURE), reduces the frequency of IPV more than an attention, time, and information matched control condition in perinatal women seeking mental health care.
Detailed Description
Intimate partner victimization (IPV) is a significant social and public health problem among perinatal women. 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. IPV and untreated mental illness during the perinatal period poses a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. 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. In addition, the presence of IPV increases the likelihood of disengagement from treatment, which could further compromise the health and safety of women and their fetus/infant. Despite the high-risk profile of women with IPV and mental health illness, there are low screening and intervention rates of female mental health patients with IPV within mental health settings. The objective of this R01 Award is to fill this critical gap by building upon our promising pilot findings to test whether the innovative intervention, "Strength for U in Relationship Empowerment" (SURE), reduces the frequency of IPV more than an attention, time, and information matched control condition in perinatal women seeking mental health care. The investigators propose a two-group, randomized controlled trial in which 186 perinatal women with IPV women seeking mental health care who will be assigned to either (a) SURE, a computer-delivered, single-session brief intervention plus one interventionist-led phone booster that is consistent with motivational interviewing and informed by the literature on effective interventions for our target population and targeted risk factors, or (b) a computer-delivered control + one interventionist-led phone booster condition. Computer-delivered follow-up assessments will occur at 6 weeks, 3 months, 6 months, and 12 months after the baseline assessment. Anticipated 25% of planned enrollment recruited by 5/14/2021. Anticipated 50% of planned enrollment recruited by 2/15/2022. Anticipated 75% of planned enrollment recruited by 8/15/2022. Anticipated 100% of planned enrollment recruited by 2/13/2023. Anticipated completion of primary endpoints data analyses by 6/28/2024. Anticipated reporting of results in ClinicalTrials.gov by 6/30/2025.
Investigators
Caron Zlotnick
Professor of Psychiatry and Human Behavior, Professor of Obstetrics and Gynecology, Professor of Medicine
Women and Infants Hospital of Rhode Island
Eligibility Criteria
Inclusion Criteria
- •Pregnant women
- •Women who have had a baby in the last 12 months
- •Between the ages of 18-45 years old
- •Have reported partner abuse within the last year as measured by the Woman Abuse Screening Tool (WAST)
- •Have sought mental health treatment
Exclusion Criteria
- •Cannot provide informed consent
- •Unable to understand English
- •No access to the internet or a device with internet access
- •Discomfort with internet use
- •No privacy to view a 40-minute online intervention
- •Screen positive for risk of intimate partner violence that involves severe injury or homicide
- •Screen positive for risk of spyware/stalkerware
- •At one of the two research site, study recruit is unwilling to meet for in-person study visits (if criteria 3-8 are met)
Outcomes
Primary Outcomes
Composite Abuse Scale (CAS)
Time Frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up.
The frequency of IPV will be measured using the Composite Abuse Scale. The Composite Abuse Scale is a 30-item scale with 4 subscales that measure severe combined abuse, emotional abuse, physical abuse, and harassment. Items are scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-150. The lower the score, the better or less victimization. Change scores will be used to estimate differences within and between groups.
Secondary Outcomes
- The Positive Affect and Well-being Scale (PAW)(Baseline, 6-week follow-up, 3, 6, and 12-month follow-up)
- Perceived Emotional Support (PES)(Baseline, 6-week follow-up, 3, 6, and 12-month follow-up)