Strength for U in Relationship Empowerment

NCT04218864 | Completed Results DMC

• 2 other identifiers: 1662751R01HD094801-01A1
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

IPV; Perinatal; Mental Health

Outcome Measures

Primary Outcomes (1)

• Composite Abuse Scale (CAS)

  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.

  Baseline, 6-week follow-up, 3, 6, and 12-month follow-up.

Secondary Outcomes (2)

• 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

Other Outcomes (2)

• Personal Progress Scale-Revised (PPS-R)

  Baseline, 6-week follow-up, 3, 6, and 12-month follow-up

• Self-efficacy (GSE)

  Baseline, 6-week follow-up, 3, 6, and 12-month follow-up

Study Arms (2)

Strength for U in Relationship Empowerment (SURE)

EXPERIMENTAL

Theory-driven and derived from empirical support

Behavioral: Strength for U in Relationship Empowerment (SURE)

Attention, time, and information matched control

ACTIVE COMPARATOR

Well-validated

Behavioral: Attention, time, and information matched control

Interventions

Strength for U in Relationship Empowerment (SURE) BEHAVIORAL

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

Strength for U in Relationship Empowerment (SURE)

Attention, time, and information matched control BEHAVIORAL

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

Attention, time, and information matched control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Time

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

• Title: Dr. Caron Zlotnick
• Organization: Women & Infants Hospital

czlotnick@butler.org

4014743332

Study Officials

• Caron Zlotnick, PhD

  Women and Infants Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Human Behavior, Professor of Obstetrics and Gynecology, Professor of Medicine

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: January 6, 2020
• Study Start: January 2, 2020
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)