Strength for U in Relationship Empowerment

NCT ID: NCT04218864

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2024-02-09

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.

Conditions

IPV; Perinatal; Mental Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Strength for U in Relationship Empowerment (SURE)

Theory-driven and derived from empirical support

Group Type: EXPERIMENTAL

Strength for U in Relationship Empowerment (SURE)

Intervention Type: BEHAVIORAL

A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.

Attention, time, and information matched control

Well-validated

Group Type: ACTIVE_COMPARATOR

Attention, time, and information matched control

Intervention Type: BEHAVIORAL

A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows

Interventions

Strength for U in Relationship Empowerment (SURE)

A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.

Intervention Type: BEHAVIORAL

Attention, time, and information matched control

A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Caron Zlotnick

Professor of Psychiatry and Human Behavior, Professor of Obstetrics and Gynecology, Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caron Zlotnick, PhD

Role: PRINCIPAL_INVESTIGATOR

Women and Infants Hospital

Locations

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01HD094801-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

166275

Identifier Type: -

Identifier Source: org_study_id