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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD094801-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strength for U in Relationship Empowerment (SURE) | Experimental | Theory-driven and derived from empirical support |
|
| Attention, time, and information matched control | Active Comparator | Well-validated |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strength for U in Relationship Empowerment (SURE) | Behavioral | A brief computer-based intervention (one session plus one booster session) based on motivational interviewing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Personal Progress Scale-Revised (PPS-R) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caron Zlotnick, PhD | Women and Infants Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women and Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
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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| ID | Title | Description |
|---|---|---|
| FG000 | Strength for U in Relationship Empowerment (SURE) | Theory-driven and derived from empirical support Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing. |
| FG001 | Attention, Time, and Information Matched Control | Well-validated Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Strength for U in Relationship Empowerment (SURE) | Theory-driven and derived from empirical support Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing. |
| BG001 | Attention, Time, and Information Matched Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All baseline outcome measures were missing for one subject due to a software issue. As a consequence, the outcome analysis was carried out with data from 121 participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6-week follow-up, 3, 6, and 12-month follow-up. |
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Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strength for U in Relationship Empowerment (SURE) | Theory-driven and derived from empirical support Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Specific events include hospitalizations due to stillbirth, shortened cervix, and pregnancy-related psoriasis and pulmonary edema. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caron Zlotnick | Women & Infants Hospital | 4014743332 | czlotnick@butler.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2020 | Jun 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013995 | Time |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| Attention, time, and information matched control | Behavioral | A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows |
|
| 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. | Baseline, 6-week follow-up, 3, 6, and 12-month follow-up |
| Baseline, 6-week follow-up, 3, 6, and 12-month follow-up |
| Self-efficacy (GSE) | 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, 6-week follow-up, 3, 6, and 12-month follow-up |
Well-validated Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Attention, Time, and Information Matched Control | Well-validated Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows |
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| Secondary | 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. | All baseline outcome measures were missing for one subject due to a software issue. As a consequence, the outcome analysis was carried out with data from 121 participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6-week follow-up, 3, 6, and 12-month follow-up |
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| Secondary | 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. | All baseline outcome measures were missing for one subject due to a software issue. As a consequence, the outcome analysis was carried out with data from 121 participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6-week follow-up, 3, 6, and 12-month follow-up |
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| Other Pre-specified | Personal Progress Scale-Revised (PPS-R) | 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. | All baseline outcome measures were missing for one subject due to a software issue. As a consequence, the outcome analysis was carried out with data from 121 participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6-week follow-up, 3, 6, and 12-month follow-up |
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| Other Pre-specified | Self-efficacy (GSE) | 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. | All baseline outcome measures were missing for one subject due to a software issue. As a consequence, the outcome analysis was carried out with data from 121 participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6-week follow-up, 3, 6, and 12-month follow-up |
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| 0 |
| 65 |
| 24 |
| 65 |
| 0 |
| 65 |
| EG001 | Attention, Time, and Information Matched Control | Well-validated Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows | 0 | 57 | 17 | 57 | 0 | 57 |
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| Hospitalization | Renal and urinary disorders | Systematic Assessment | Specific events include hospitalizations due to gallbladder removal and kidney infection. |
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| IPV Altercation (non-study related) | Social circumstances | Systematic Assessment | All non-study related. |
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| Hospitalization | Psychiatric disorders | Systematic Assessment | Specific events include hospitalizations for depression, stress and past trauma, suicidal ideation and/or attempt, generic mental health reasons, and not feeling safe at home in terms of self-harm. |
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| Housing | Social circumstances | Systematic Assessment | Specific events include danger or threats from someone other than an intimate partner and being in the vicinity of gunshots during a neighborhood dispute. |
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| Hospitalization | Infections and infestations | Systematic Assessment | Specific event was a hospitalization due to a pelvic infection. |
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| Hospitalization | Ear and labyrinth disorders | Systematic Assessment | Specific event was a hospitalization due to ear pain and vertigo. |
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| 3-month follow-up |
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| 6-month follow-up |
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| 12-month follow-up |
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| 3- Month |
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| 6- Month |
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| 12-Month |
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| 3-Month |
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| 6-Month |
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| 12-Month |
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| 3- Month |
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| 6- Month |
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| 12-Month |
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