Strength for U in Relationship Empowerment (SURE)

Computerized Intervention for Reducing Intimate Partner Violence for Perinatal Women Seeking Mental Health Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mental Health; IPV; Perinatal
• Intervention / Treatment: Behavioral: Strength for U in Relationship Empowerment (SURE); Behavioral: Attention, time, and information matched control

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.

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tasneem Tweel, MPH; Phone Number: 734-998-0333; Email: tasneemt@med.umich.edu
• Study Contact Backup: Name: Caron Zlotnick, PhD; Phone Number: 4014743332; Email: czlotnick@butler.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women and Infants Hospital of Rhode Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strength for U in Relationship Empowerment (SURE); Theory-driven and derived from empirical support	Behavioral: Strength for U in Relationship Empowerment (SURE); A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
Active Comparator: Attention, time, and information matched control; Well-validated	Behavioral: Attention, time, and information matched control; A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Abuse Scale (CAS)	The frequency of IPV will be measured using the Composite Abuse Scale (CAS). The CAS 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. Mean score will be used to calculate differences between baseline and follow-up and between groups.	Baseline, 6 week follow up through 12 months follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Positive Affect and Well-being Scale (PAW)	Positive affect and well-begin will be measured by using the National Institutes of Health (NIH) Quality of Life in Neurological Disorders (Neuro-QoL) scale for Positive Affect and Well-being (PAW), a computerized adaptive test 9-item scale. This scale is scored between 1 and 5, with Never=1 and Always=5. Scale range is from 9-45. Higher scores indicate higher positive affect, life satisfaction, or an overall sense of purpose and meaning. Mean score will be used to calculate differences between baseline and follow-up and between groups.	Baseline, 6 week follow up through 12 months follow up.
PROMIS Emotional Support	Perceived emotional support will be measured using a 4-item scale developed by the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS is a National Institutes of Health (NIH) Roadmap initiative that provides precise, reliable, valid, and standardized questionnaires measuring patient-reported outcomes across the domains of physical, mental, and social health. The PROMIS Emotional Support item bank specifically aims to measure perceived feelings of being cared for and valued as a person. This scale is scored between 1 and 5, with Never=1 and Always=5. Scale range is from 4-16. A higher PROMIS score represents increased emotional support. Mean score will be used to calculate differences between baseline and follow-up and between groups.	Baseline, 6 week follow up through 12 months follow up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Progress Scale-Revised (PPS-R)	Empowerment will be measured using the Personal Progress Scale-Revised (PPS-R) for measuring skills, social supports, and resources to cope more effectively with relationship stress and trauma. The PPS-R is a 28-item scale scored between 1 and 7, with 1=Almost Never and 7=Almost Always. Scale range is from 28-196. Higher scores indicating higher empowerment. Mean score will be used to calculate differences between baseline and follow-up and between groups.	Baseline, 6 week follow up through 12 months follow up.
Self-efficacy	Self-efficacy will be measured using the General Self-Efficacy Scale (GSE), a 10-item self-report measure. It measures personal competence to deal effectively with a variety of stressful situations. The GSE is scored from 10-40, with 1=Not at all true and 4=Exactly true. A higher score indicates more self-efficacy. Mean score will be used to calculate differences between baseline and follow-up and between groups.	Baseline, 6 week follow up through 12 months follow up.

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Caron Zlotnick, PhD, Women and Infants Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 166275; 1R01HD094801-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study team does not currently have a plan to share data. However, the team is currently in discussion about sharing data and will update the registration as needed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No