Clinical trial NCT04218864: Strength for U in Relationship Empowerment
Official title: Computerized Intervention for Reducing Intimate Partner Violence for Perinatal Women Seeking Mental Health Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: IPV
Perinatal
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: 2020-01-06
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 6/30/2024.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women
2. Women who have had a baby in the last 12 months
3. Between the ages of 18-45 years old
4. Have reported partner abuse within the last year as measured by the Woman Abuse Screening Tool (WAST)
5. Have sought mental health treatment

Exclusion Criteria:

1. Cannot provide informed consent
2. Unable to understand English
3. No access to the internet or a device with internet access
4. Discomfort with internet use
5. No privacy to view a 40-minute online intervention
6. Screen positive for risk of intimate partner violence that involves severe injury or homicide
7. Screen positive for risk of spyware/stalkerware
8. At one of the two research site, study recruit is unwilling to meet for in-person study visits (if criteria 3-8 are met)

Primary outcomes:
measure: Composite Abuse Scale (CAS)
timeFrame: Baseline, 6 week follow up through 12 months follow up.
Secondary outcomes:
measure: The Positive Affect and Well-being Scale (PAW)
timeFrame: Baseline, 6 week follow up through 12 months follow up.
measure: PROMIS Emotional Support
timeFrame: Baseline, 6 week follow up through 12 months follow up.
Other outcomes:
measure: Personal Progress Scale-Revised (PPS-R)
timeFrame: Baseline, 6 week follow up through 12 months follow up.
measure: Self-efficacy
timeFrame: Baseline, 6 week follow up through 12 months follow up.
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital
name: Caron Zlotnick, PhD
role: PRINCIPAL_INVESTIGATOR
References: