IPVSURENCT04218864
Strength for U in Relationship Empowerment
A study testing Strength for U in Relationship Empowerment (SURE) in people with IPV and Perinatal, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- IPV, Perinatal, Mental Health
- What is being tested?
- Strength for U in Relationship Empowerment (SURE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2020to 9 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
Official title: 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.
Read the 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
- Being tested
- Strength for U in Relationship Empowerment (SURE), Attention, time, and information matched control
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength for U in Relationship Empowerment (SURE)Behavioural
A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
Attention, time, and information matched controlBehavioural
A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
| Study group | Role | What they receive |
|---|---|---|
| Strength for U in Relationship Empowerment (SURE) | Experimental | Theory-driven and derived from empirical support Receives: Behavioral: Strength for U in Relationship Empowerment (SURE) |
| Attention, time, and information matched control | Active comparator | Well-validated Receives: Behavioral: Attention, time, and information matched control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up.
Secondary outcomes (2)
The Positive Affect and Well-being Scale (PAW)
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.
Measured: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up
Perceived Emotional Support (PES)
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.
Measured: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start2 Jan 2020
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IPVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Caron Zlotnick, Women and Infants Hospital of Rhode Island
- Investigators
- Caron Zlotnick, PhD, Principal investigator, Women and Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218864
- Sponsor's protocol ID
- 166275
- Other IDs
- 1R01HD094801-01A1
- Acronym
- SURE
- Status last verified
- Jul 2025
- First submitted
- 5 Dec 2019
- Last updated
- 1 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Intervention for Reducing Intimate Partner Violence for Perinatal Women Seeking Mental Health Treatment
- ClinicalTrials.gov ID
- NCT04218864
- Acronym / sponsor ID
- SURE / 166275
- Conditions
- IPV, Perinatal, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Posted 1 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength for U in Relationship Empowerment (SURE) | Experimental | Behavioral: Strength for U in Relationship Empowerment (SURE)Theory-driven and derived from empirical support |
| Attention, time, and information matched control | Active comparator | Behavioral: Attention, time, and information matched controlWell-validated |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength for U in Relationship Empowerment (SURE)A brief computer-based intervention (one session plus one booster session) based on motivational interviewing. | Behavioural | Strength for U in Relationship Empowerment (SURE) |
| Attention, time, and information matched controlA brief computer based intervention (one session plus booster session) that involves viewing of popular television shows | Behavioural | Attention, time, and information matched control |
Primary outcome
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.
2 secondary outcomes
The Positive Affect and Well-being Scale (PAW)
Time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up
Perceived Emotional Support (PES)
Time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caron Zlotnick, PhD principal investigator
Women and Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength for U in Relationship Empowerment (SURE) in people with IPV and Perinatal, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Abuse Scale (CAS) (time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.