Strength for U in Relationship Empowerment

Mental Health Clinical Trial

— SURE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04218864
• Other study ID #: 166275
• Secondary ID: 1R01HD094801-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2023
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 6/30/2024.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 186
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• IPV
• Mental Health
• Perinatal

Intervention

Behavioral:
• Strength for U in Relationship Empowerment (SURE)
A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
• Attention, time, and information matched control
A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows

Locations

Country	Name	City	State
United States	Women and Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Personal Progress Scale-Revised (PPS-R)	Empowerment will be measured using the Personal Progress Scale-Revised (PPS-R) for measuring skills, social supports, and resources to cope more effectively with relationship stress and trauma. The PPS-R 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. Mean score will be used to calculate differences between baseline and follow-up and between groups.	Baseline, 6 week follow up through 12 months follow up.
Other	Self-efficacy	Self-efficacy will be measured using the General Self-Efficacy Scale (GSE), a 10-item self-report measure. It measures personal competence to deal effectively with a variety of stressful situations. The GSE is scored from 10-40, with 1=Not at all true and 4=Exactly true. A higher score indicates more self-efficacy. Mean score will be used to calculate differences between baseline and follow-up and between groups.	Baseline, 6 week follow up through 12 months follow up.
Primary	Composite Abuse Scale (CAS)	The frequency of IPV will be measured using the Composite Abuse Scale (CAS). The CAS 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. Mean score will be used to calculate differences between baseline and follow-up and between groups.	Baseline, 6 week follow up through 12 months follow up.
Secondary	The Positive Affect and Well-being Scale (PAW)	Positive affect and well-begin will be measured by using the National Institutes of Health (NIH) Quality of Life in Neurological Disorders (Neuro-QoL) scale for Positive Affect and Well-being (PAW), 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. Mean score will be used to calculate differences between baseline and follow-up and between groups.	Baseline, 6 week follow up through 12 months follow up.
Secondary	PROMIS Emotional Support	Perceived emotional support will be measured using a 4-item scale developed by the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS is a National Institutes of Health (NIH) Roadmap initiative that provides precise, reliable, valid, and standardized questionnaires measuring patient-reported outcomes across the domains of physical, mental, and social health. The PROMIS 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 4-16. A higher PROMIS score represents increased emotional support. Mean score will be used to calculate differences between baseline and follow-up and between groups.	Baseline, 6 week follow up through 12 months follow up.