IPV, Mental Health, Perinatal
Conditions
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.
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.
Interventions
BEHAVIORALStrength for U in Relationship Empowerment (SURE)
A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
BEHAVIORALAttention, time, and information matched control
A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnant women 2. Women who have had a baby in the last 12 months 3. Between the ages of 18-45 years old 4. Have reported partner abuse within the last year as measured by the Woman Abuse Screening Tool (WAST) 5. Have sought mental health treatment
Exclusion criteria
1. Cannot provide informed consent 2. Unable to understand English 3. No access to the internet or a device with internet access 4. Discomfort with internet use 5. No privacy to view a 40-minute online intervention 6. Screen positive for risk of intimate partner violence that involves severe injury or homicide 7. Screen positive for risk of spyware/stalkerware 8. At one of the two research site, study recruit is unwilling to meet for in-person study visits (if criteria 3-8 are met)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Abuse Scale (CAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| The Positive Affect and Well-being Scale (PAW) | 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. |
| Perceived Emotional Support (PES) | 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
| Measure | Time frame | Description |
|---|---|---|
| Personal Progress Scale-Revised (PPS-R) | 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. |
| Self-efficacy (GSE) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 65 |
| 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 | 57 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Strength for U in Relationship Empowerment (SURE) | Attention, Time, and Information Matched Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 57 Participants | 122 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 13 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 44 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Bi-Racial or Multi-Ethnic | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black | 13 Participants | 16 Participants | 29 Participants |
| Race/Ethnicity, Customized Caucasian/White | 45 Participants | 33 Participants | 78 Participants |
| Race/Ethnicity, Customized Native American or Native Alaskan | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 65 Participants | 57 Participants | 122 Participants |
| Sex: Female, Male Female | 65 Participants | 57 Participants | 122 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Female | 65 Participants | 57 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 57 |
| other Total, other adverse events | 0 / 65 | 0 / 57 |
| serious Total, serious adverse events | 24 / 65 | 17 / 57 |
Outcome results
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.
Time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength for U in Relationship Empowerment (SURE) | Composite Abuse Scale (CAS) | 6-month follow-up | 8.89 units on a scale | Standard Deviation 12.06 |
| Strength for U in Relationship Empowerment (SURE) | Composite Abuse Scale (CAS) | Baseline | 29.13 units on a scale | Standard Deviation 20.92 |
| Strength for U in Relationship Empowerment (SURE) | Composite Abuse Scale (CAS) | 6-week follow-up | 10.54 units on a scale | Standard Deviation 12.02 |
| Strength for U in Relationship Empowerment (SURE) | Composite Abuse Scale (CAS) | 3-month follow-up | 9.69 units on a scale | Standard Deviation 10.39 |
| Strength for U in Relationship Empowerment (SURE) | Composite Abuse Scale (CAS) | 12-month follow-up | 11.45 units on a scale | Standard Deviation 14.56 |
| Attention, Time, and Information Matched Control | Composite Abuse Scale (CAS) | 12-month follow-up | 7.5 units on a scale | Standard Deviation 12.02 |
| Attention, Time, and Information Matched Control | Composite Abuse Scale (CAS) | 3-month follow-up | 8.27 units on a scale | Standard Deviation 11.06 |
| Attention, Time, and Information Matched Control | Composite Abuse Scale (CAS) | Baseline | 27.01 units on a scale | Standard Deviation 20.65 |
| Attention, Time, and Information Matched Control | Composite Abuse Scale (CAS) | 6-month follow-up | 8.7 units on a scale | Standard Deviation 10.95 |
| Attention, Time, and Information Matched Control | Composite Abuse Scale (CAS) | 6-week follow-up | 10.02 units on a scale | Standard Deviation 12.78 |
Comparison: Linear Mixed regression models (LMM) have been used to identify any difference between the intervention and the control groups over time with regards to the continuous outcomes. Group (intervention vs. control), a 5-category time (baseline, 6 week, 3 month, 6 month, 12 month) and group-by-time interaction are covariates in the model. A random subject intercept is used to account for clustering within subject.p-value: >0.05Regression, Linear
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.
Time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength for U in Relationship Empowerment (SURE) | Perceived Emotional Support (PES) | 6- Week | 15.41 units on a scale | Standard Deviation 3.63 |
| Strength for U in Relationship Empowerment (SURE) | Perceived Emotional Support (PES) | 6- Month | 15.15 units on a scale | Standard Deviation 3.54 |
| Strength for U in Relationship Empowerment (SURE) | Perceived Emotional Support (PES) | 3- Month | 15.75 units on a scale | Standard Deviation 3.45 |
| Strength for U in Relationship Empowerment (SURE) | Perceived Emotional Support (PES) | 12-Month | 16.02 units on a scale | Standard Deviation 3.67 |
| Strength for U in Relationship Empowerment (SURE) | Perceived Emotional Support (PES) | Baseline | 14.61 units on a scale | Standard Deviation 4.15 |
| Attention, Time, and Information Matched Control | Perceived Emotional Support (PES) | 12-Month | 15.58 units on a scale | Standard Deviation 4 |
| Attention, Time, and Information Matched Control | Perceived Emotional Support (PES) | Baseline | 14.89 units on a scale | Standard Deviation 4.16 |
| Attention, Time, and Information Matched Control | Perceived Emotional Support (PES) | 6- Week | 15.32 units on a scale | Standard Deviation 4.23 |
| Attention, Time, and Information Matched Control | Perceived Emotional Support (PES) | 3- Month | 14.77 units on a scale | Standard Deviation 4.46 |
| Attention, Time, and Information Matched Control | Perceived Emotional Support (PES) | 6- Month | 15.12 units on a scale | Standard Deviation 3.49 |
Comparison: Statistical analysis strategy is identical to that for the primary outcome.p-value: >0.05Regression, Linear
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.
Time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength for U in Relationship Empowerment (SURE) | The Positive Affect and Well-being Scale (PAW) | 6-week follow-up | 31.68 units on a scale | Standard Deviation 6.43 |
| Strength for U in Relationship Empowerment (SURE) | The Positive Affect and Well-being Scale (PAW) | 6-month follow-up | 32.64 units on a scale | Standard Deviation 6.08 |
| Strength for U in Relationship Empowerment (SURE) | The Positive Affect and Well-being Scale (PAW) | 3-month follow-up | 33.21 units on a scale | Standard Deviation 5.91 |
| Strength for U in Relationship Empowerment (SURE) | The Positive Affect and Well-being Scale (PAW) | 12-month follow-up | 33.59 units on a scale | Standard Deviation 5.75 |
| Strength for U in Relationship Empowerment (SURE) | The Positive Affect and Well-being Scale (PAW) | Baseline | 29.39 units on a scale | Standard Deviation 7.32 |
| Attention, Time, and Information Matched Control | The Positive Affect and Well-being Scale (PAW) | 12-month follow-up | 32.93 units on a scale | Standard Deviation 6.64 |
| Attention, Time, and Information Matched Control | The Positive Affect and Well-being Scale (PAW) | Baseline | 29.95 units on a scale | Standard Deviation 7.17 |
| Attention, Time, and Information Matched Control | The Positive Affect and Well-being Scale (PAW) | 6-week follow-up | 32.05 units on a scale | Standard Deviation 6.68 |
| Attention, Time, and Information Matched Control | The Positive Affect and Well-being Scale (PAW) | 3-month follow-up | 31.4 units on a scale | Standard Deviation 6.84 |
| Attention, Time, and Information Matched Control | The Positive Affect and Well-being Scale (PAW) | 6-month follow-up | 30.84 units on a scale | Standard Deviation 6.51 |
Comparison: Statistical analysis strategy is identical to that for the primary outcome.p-value: >0.05Regression, Linear
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.
Time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength for U in Relationship Empowerment (SURE) | Personal Progress Scale-Revised (PPS-R) | 6-Week | 109.08 units on a scale | Standard Deviation 14.39 |
| Strength for U in Relationship Empowerment (SURE) | Personal Progress Scale-Revised (PPS-R) | 6-Month | 111.42 units on a scale | Standard Deviation 14.01 |
| Strength for U in Relationship Empowerment (SURE) | Personal Progress Scale-Revised (PPS-R) | 3-Month | 111.4 units on a scale | Standard Deviation 13.4 |
| Strength for U in Relationship Empowerment (SURE) | Personal Progress Scale-Revised (PPS-R) | 12-Month | 114.1 units on a scale | Standard Deviation 16.44 |
| Strength for U in Relationship Empowerment (SURE) | Personal Progress Scale-Revised (PPS-R) | Baseline | 129.53 units on a scale | Standard Deviation 21.66 |
| Attention, Time, and Information Matched Control | Personal Progress Scale-Revised (PPS-R) | 12-Month | 110.87 units on a scale | Standard Deviation 12.03 |
| Attention, Time, and Information Matched Control | Personal Progress Scale-Revised (PPS-R) | Baseline | 132.56 units on a scale | Standard Deviation 22.62 |
| Attention, Time, and Information Matched Control | Personal Progress Scale-Revised (PPS-R) | 6-Week | 113.66 units on a scale | Standard Deviation 11.72 |
| Attention, Time, and Information Matched Control | Personal Progress Scale-Revised (PPS-R) | 3-Month | 113.74 units on a scale | Standard Deviation 14.11 |
| Attention, Time, and Information Matched Control | Personal Progress Scale-Revised (PPS-R) | 6-Month | 113.84 units on a scale | Standard Deviation 14.11 |
Comparison: Statistical analysis strategy is identical to that for primary outcome.p-value: >0.05Regression, Linear
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.
Time frame: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength for U in Relationship Empowerment (SURE) | Self-efficacy (GSE) | 6- Week | 28.71 units on a scale | Standard Deviation 4.17 |
| Strength for U in Relationship Empowerment (SURE) | Self-efficacy (GSE) | 6- Month | 29.49 units on a scale | Standard Deviation 4.23 |
| Strength for U in Relationship Empowerment (SURE) | Self-efficacy (GSE) | 3- Month | 29.67 units on a scale | Standard Deviation 3.82 |
| Strength for U in Relationship Empowerment (SURE) | Self-efficacy (GSE) | 12-Month | 30.72 units on a scale | Standard Deviation 3.94 |
| Strength for U in Relationship Empowerment (SURE) | Self-efficacy (GSE) | Baseline | 28.45 units on a scale | Standard Deviation 4.57 |
| Attention, Time, and Information Matched Control | Self-efficacy (GSE) | 12-Month | 29.79 units on a scale | Standard Deviation 4.7 |
| Attention, Time, and Information Matched Control | Self-efficacy (GSE) | Baseline | 27.34 units on a scale | Standard Deviation 4.8 |
| Attention, Time, and Information Matched Control | Self-efficacy (GSE) | 6- Week | 28.68 units on a scale | Standard Deviation 5.23 |
| Attention, Time, and Information Matched Control | Self-efficacy (GSE) | 3- Month | 29.57 units on a scale | Standard Deviation 5.32 |
| Attention, Time, and Information Matched Control | Self-efficacy (GSE) | 6- Month | 28.84 units on a scale | Standard Deviation 4.58 |
Comparison: Statistical Analysis strategy is identical to that for primary outcome measure.p-value: >0.05Regression, Linear