Strength for U in Relationship Empowerment (SURE)

Women and Infants Hospital of Rhode Island

Status

Completed

Conditions

IPV

Perinatal

Mental Health

Treatments

Behavioral: Strength for U in Relationship Empowerment (SURE)

Behavioral: Attention, time, and information matched control

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04218864

1R01HD094801-01A1 (U.S. NIH Grant/Contract)

166275

Details and patient eligibility

About

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.

Full 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.

Enrollment

122 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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)