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Completed

NCT Number: NCT04218864

Strength for U in Relationship Empowerment

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Strength for U in Relationship Empowerment (SURE)

Behavioral

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

Attention, time, and information matched control

Behavioral

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

Primary outcomes

  1. Composite Abuse Scale (CAS)

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

    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.

Secondary outcomes

  1. The Positive Affect and Well-being Scale (PAW)

    Time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up

    Positive affect and well-being will be measured by using the National Institutes of Health Quality of Life in Neurological Disorders scale for Positive Affect and Well-being 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. Change scores will be used to estimate differences within and between groups.

  2. Perceived Emotional Support (PES)

    Time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up

    Perceived emotional support will be measured using a 4-item scale developed by the Patient-Reported Outcomes Measurement Information System . Patient-Reported Outcomes Measurement Information System is a National Institutes of Health Roadmap initiative that provides precise, reliable, valid, and standardized questionnaires measuring patient-reported outcomes across the domains of physical, mental, and social health. The Patient-Reported Outcomes Measurement Information System .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 4-20. A higher Patient-Reported Outcomes Measurement Information System score represents increased emotional support. Change scores will be used to estimate differences within and between groups.

Other outcomes

  1. Personal Progress Scale-Revised (PPS-R)

    Time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up

    Empowerment will be measured using the Personal Progress Scale-Revised for measuring skills, social supports, and resources to cope more effectively with relationship stress and trauma. The Personal Progress Scale-Revised 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. Change scores will be used to estimate differences within and between groups.

  2. Self-efficacy (GSE)

    Time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up

    Self-efficacy will be measured using the General Self-Efficacy Scale a 10-item self-report measure. It measures personal competence to deal effectively with a variety of stressful situations. The General Self-Efficacy Scale is scored from 10-40, with 1=Not at all true and 4=Exactly true. A higher score indicates more self-efficacy. Change scores will be used to estimate differences within and between groups.

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SURE

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2020
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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