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NCT04218864: SURE

Strength for U in Relationship Empowerment

Completed NA Results posted Last updated 1 August 2025
What this trial tests

NA trial testing Strength for U in Relationship Empowerment (SURE) in IPV in 122 participants. Completed in 9 February 2024.

Timeline
2 January 2020
Primary endpoint
9 February 2024
9 February 2024

Quick facts

Lead sponsorWomen and Infants Hospital of Rhode Island
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment122
Start date2 January 2020
Primary completion9 February 2024
Estimated completion9 February 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Women and Infants Hospital of Rhode Island

Who can join

Adults 18 to 45, female only, with IPV or Perinatal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Composite Abuse Scale (CAS) Primary · 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.

Baseline
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)29.13± 20.92
Attention, Time, and Information Matched Control27.01± 20.65
6-week follow-up
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)10.54± 12.02
Attention, Time, and Information Matched Control10.02± 12.78
3-month follow-up
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)9.69± 10.39
Attention, Time, and Information Matched Control8.27± 11.06
6-month follow-up
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)8.89± 12.06
Attention, Time, and Information Matched Control8.7± 10.95
12-month follow-up
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)11.45± 14.56
Attention, Time, and Information Matched Control7.5± 12.02
The Positive Affect and Well-being Scale (PAW) Secondary · 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.

Baseline
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)29.39± 7.32
Attention, Time, and Information Matched Control29.95± 7.17
6-week follow-up
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)31.68± 6.43
Attention, Time, and Information Matched Control32.05± 6.68
3-month follow-up
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)33.21± 5.91
Attention, Time, and Information Matched Control31.4± 6.84
6-month follow-up
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)32.64± 6.08
Attention, Time, and Information Matched Control30.84± 6.51
12-month follow-up
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)33.59± 5.75
Attention, Time, and Information Matched Control32.93± 6.64
Perceived Emotional Support (PES) Secondary · 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.

Baseline
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)14.61± 4.15
Attention, Time, and Information Matched Control14.89± 4.16
6- Week
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)15.41± 3.63
Attention, Time, and Information Matched Control15.32± 4.23
3- Month
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)15.75± 3.45
Attention, Time, and Information Matched Control14.77± 4.46
6- Month
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)15.15± 3.54
Attention, Time, and Information Matched Control15.12± 3.49
12-Month
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)16.02± 3.67
Attention, Time, and Information Matched Control15.58± 4
Personal Progress Scale-Revised (PPS-R) Secondary · 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.

Baseline
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)129.53± 21.66
Attention, Time, and Information Matched Control132.56± 22.62
6-Week
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)109.08± 14.39
Attention, Time, and Information Matched Control113.66± 11.72
3-Month
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)111.4± 13.4
Attention, Time, and Information Matched Control113.74± 14.11
6-Month
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)111.42± 14.01
Attention, Time, and Information Matched Control113.84± 14.11
12-Month
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)114.1± 16.44
Attention, Time, and Information Matched Control110.87± 12.03
Self-efficacy (GSE) Secondary · 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.

Baseline
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)28.45± 4.57
Attention, Time, and Information Matched Control27.34± 4.8
6- Week
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)28.71± 4.17
Attention, Time, and Information Matched Control28.68± 5.23
3- Month
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)29.67± 3.82
Attention, Time, and Information Matched Control29.57± 5.32
6- Month
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)29.49± 4.23
Attention, Time, and Information Matched Control28.84± 4.58
12-Month
GroupValue95% CI
Strength for U in Relationship Empowerment (SURE)30.72± 3.94
Attention, Time, and Information Matched Control29.79± 4.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Strength for U in Relationship Empowerment (SURE)
Serious: 24/65 (37%)
Deaths: 0/65
Attention, Time, and Information Matched Control
Serious: 17/57 (30%)
Deaths: 0/57

Serious adverse events (7 terms)

ReactionSystemStrength for U in Relation…Attention, Time, and Infor…
IPV Altercation (non-study related)Social circumstances
HospitalizationPsychiatric disorders
HospitalizationPregnancy, puerperium and perinatal conditions
HospitalizationRenal and urinary disorders
HousingSocial circumstances
HospitalizationInfections and infestations
HospitalizationEar and labyrinth disorders

Most-reported serious reactions: IPV Altercation (non-study related), Hospitalization, Hospitalization, Hospitalization, Housing, Hospitalization, Hospitalization.

Data from ClinicalTrials.gov NCT04218864 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Computerized intervention for reducing intimate partner victimization for perinatal women seeking mental health treatment: A multisite randomized clinical trial protocol.
    Johnson DM, Tzilos Wernette G, Miller TR, Muzik M, et al · · 2020 · cited 4× · PMID 32305456 · DOI 10.1016/j.cct.2020.106011
  2. Web-based intervention to reduce intimate partner violence during perinatal period: A modified protocol in response to the COVID-19 pandemic.
    Johnson E, Jenssen S, Wernette GT, Tweel T, et al · · 2022 · cited 3× · PMID 37406076 · DOI 10.1016/j.psychres.2022.114895

Verify or expand the search:

Other recruiting trials for IPV

Currently open trials in the same condition.

Other Women and Infants Hospital of Rhode Island trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04218864.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing