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Intervention for IPV Perinatal Women- RCT

Computer-Based Intervention for Victimized Perinatal Women With Mental Illness (Phase 1)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02370394
Enrollment
53
Registered
2015-02-24
Start date
2015-03-31
Completion date
2016-09-30
Last updated
2018-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intimate Partner Violence

Keywords

Intimate Partner Violence, Perinatal Women, Mental Health

Brief summary

The study developed and assessed an innovative, high-reach, easily implementable, low-cost computer-delivered intervention (Reach out for a Safe Environment; ROSE Program) that addressed known barriers in early identification and intervention with perinatal women with IPV seeking treatment for mental illness.

Detailed description

Intimate partner violence (IPV) is a significant social and public health problem among perinatal women. Research suggests that from 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, 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. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. Experts in the field advocate for more IPV screening and intervention to take place among women who are at high-risk for IPV. 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. Further, the presence of IPV increases the likelihood of disengagement from treatment, which could compromise the ability of women with IPV to effectively use important shelter and community resources necessary for establishing safety for themselves and their children. A timely intervention might reduce the risk of future IPV, improve treatment utilization, and reduce mental health symptoms. A brief intervention that is designed specifically for the unique needs of perinatal women with IPV seeking mental health treatment provides a tremendous opportunity to intervene with a group of women who are particularly vulnerable and who might be unusually open to making changes to their lives. This study is the first step towards developing a computer-based brief intervention (Reach Out for a Safe Environment) that targets intimate partner violence in perinatal women in mental health treatment and constitutes the developmental aims of a larger study. The aims were to perform a small open trial (n = 8) of the Reach Out for a Safe Environment (ROSE) intervention to assess feasibility of recruitment of target population and acceptability of intervention and study procedures. Also, to conduct a randomized controlled pilot study in a sample of 50 perinatal women seeking mental health treatment who screen positive for recent IPV to demonstrate the acceptability and feasibility of the ROSE intervention via participant report of ease of use, helpfulness, and overall satisfaction. We collected several measures on the feasibility of the research design, the acceptability of ROSE, and on intervention effects for IPV severity and level of self-care strategies (primary outcomes), motivation and self efficacy (secondary outcomes), and use of recommended mental health treatment services (tertiary outcome). This phase used a two-group, randomized, controlled design with an initial session for both conditions plus booster session one month later for the intervention condition. The initial intervention session was conducted close to an intake visit for mental health difficulties, with a booster session within one month following baseline. There was a 3-month follow up assessment. Assessments and the booster session were conducted in a private room or at a location that was a convenient location for the woman and one that provided a confidential, safe, and comfortable environment for the participant.

Interventions

BEHAVIORALROSE Program

The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was tailored to the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Pregnant or postpartum women (up to 6 months after delivery) * Age 18 or older * Seeking mental health treatment at The Center for Women's Behavioral Health (WBH) at Women and Infants Hospital (WIH) * Endorsed any IPV during the past 12 months as measured by the Woman Abuse Screening Tool (WAST)

Exclusion criteria

* Inability to provide informed consent (e.g., due to psychosis, intoxication, or other clear cognitive impairment) * Inability to understand English (understand the consent form when read aloud and assessments that are narrated by computer)

Design outcomes

Primary

MeasureTime frameDescription
Composite Abuse Scale (CAS)-CAS Victimization Total ScoreAssessed at baseline, and again three months laterA widely used self-report of behaviors that includes a 36-item scale - only the CAS Victimization Total score was calculated. Items were scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-180. Mean score was used to calculate differences between baseline and follow-up and between groups. The lower the score, the better or less victimization.
Safety Behavior Checklist (SBC)Assessed at baseline, and again three months laterIncludes 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Items were scored as Yes=1 or No=0 or Not applicable. Scale range is from 0-15. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more use of safety behaviors.
Effectiveness in Obtaining Resources Scale (EOR)Assessed at baseline, and again three months laterAssesses the women's effectiveness in obtaining resources from 11 different types of community resources including mental health treatment, church or clergy, health care, legal services, police, or social services. Items were scored as Yes=1 or No=0. Scale range is from 0-11. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more they were effective in obtaining resources.

Secondary

MeasureTime frameDescription
Motivation ScaleAssessed at baseline, and again three months laterA 1-item measure, was modified to assess how ready they are to use treatment, resources, and/or support for any partner abuse. This item was scored with a range from 0-10. 0=not ready at all to 10=completely ready. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to use treatment, resources, or support for any partner abuse.
The Readiness to Change Contemplation LadderAssessed at baseline, and again three months laterOne item measure to assess readiness to make changes to increase safety. This item was scored with a range from 0-10. 0=not prepared to change to 10=already changing. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to make changes to increase safety.

Countries

United States

Participant flow

Recruitment details

We recruited perinatal women from The Center for Women's Behavioral Health (WBH) at Women and Infants Hospital (WIH) between May 2015 and April 2016.

Participants by arm

ArmCount
ROSE Program
Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program. ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.
28
Control Condition
Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
25
Total53

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up21
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicROSE ProgramControl ConditionTotal
Age, Categorical
<=18 years
1 Participants1 Participants2 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
27 Participants24 Participants51 Participants
Age, Continuous27.03 years28.32 years27.64 years
Sex: Female, Male
Female
28 Participants25 Participants53 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 25
other
Total, other adverse events
0 / 280 / 25
serious
Total, serious adverse events
9 / 286 / 25

Outcome results

Primary

Composite Abuse Scale (CAS)-CAS Victimization Total Score

A widely used self-report of behaviors that includes a 36-item scale - only the CAS Victimization Total score was calculated. Items were scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-180. Mean score was used to calculate differences between baseline and follow-up and between groups. The lower the score, the better or less victimization.

Time frame: Assessed at baseline, and again three months later

Population: The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.

ArmMeasureGroupValue (MEAN)Dispersion
ROSE ProgramComposite Abuse Scale (CAS)-CAS Victimization Total ScoreCAS at Baseline26.36 units on a scaleStandard Deviation 17.81
ROSE ProgramComposite Abuse Scale (CAS)-CAS Victimization Total ScoreCAS at Follow-up12.38 units on a scaleStandard Deviation 12.44
Control ConditionComposite Abuse Scale (CAS)-CAS Victimization Total ScoreCAS at Baseline16.56 units on a scaleStandard Deviation 12.25
Control ConditionComposite Abuse Scale (CAS)-CAS Victimization Total ScoreCAS at Follow-up16.52 units on a scaleStandard Deviation 20.23
Comparison: CAS Victimization Total Score at Follow Upp-value: 0.401695% CI: [-14.02, 5.75]t-test, 2 sided
Comparison: Change in CAS Victimization Total score from Baseline to Follow Upp-value: 0.007295% CI: [4.11, 24.82]t-test, 2 sided
Primary

Effectiveness in Obtaining Resources Scale (EOR)

Assesses the women's effectiveness in obtaining resources from 11 different types of community resources including mental health treatment, church or clergy, health care, legal services, police, or social services. Items were scored as Yes=1 or No=0. Scale range is from 0-11. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more they were effective in obtaining resources.

Time frame: Assessed at baseline, and again three months later

Population: The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.

ArmMeasureGroupValue (MEAN)Dispersion
ROSE ProgramEffectiveness in Obtaining Resources Scale (EOR)EOR at Baseline2.46 units on a scaleStandard Deviation 1.71
ROSE ProgramEffectiveness in Obtaining Resources Scale (EOR)EOR at Follow Up3.31 units on a scaleStandard Deviation 2.59
Control ConditionEffectiveness in Obtaining Resources Scale (EOR)EOR at Baseline3.48 units on a scaleStandard Deviation 2.87
Control ConditionEffectiveness in Obtaining Resources Scale (EOR)EOR at Follow Up3.43 units on a scaleStandard Deviation 2.59
Comparison: EOR Number of issues Effective at Accomplishing at Follow Upp-value: 0.864695% CI: [-1.62, 1.36]t-test, 2 sided
Comparison: Change in Number of Issues Effective at Accomplishing from Baseline to Follow Upp-value: 0.304595% CI: [-2.54, 0.82]t-test, 2 sided
Primary

Safety Behavior Checklist (SBC)

Includes 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Items were scored as Yes=1 or No=0 or Not applicable. Scale range is from 0-15. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more use of safety behaviors.

Time frame: Assessed at baseline, and again three months later

Population: The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.

ArmMeasureGroupValue (MEAN)Dispersion
ROSE ProgramSafety Behavior Checklist (SBC)SBC at Baseline.28 units on a scaleStandard Deviation 0.23
ROSE ProgramSafety Behavior Checklist (SBC)SBC at Follow Up.28 units on a scaleStandard Deviation 0.28
Control ConditionSafety Behavior Checklist (SBC)SBC at Baseline.36 units on a scaleStandard Deviation 0.23
Control ConditionSafety Behavior Checklist (SBC)SBC at Follow Up.32 units on a scaleStandard Deviation 0.29
Comparison: Safety Behavior Change Score at Follow Upp-value: 0.601195% CI: [-0.21, 0.12]t-test, 2 sided
Comparison: Change is Safety Behavior Change Score from Baseline to Follow Upp-value: 0.911695% CI: [-0.16, 0.15]t-test, 2 sided
Secondary

Motivation Scale

A 1-item measure, was modified to assess how ready they are to use treatment, resources, and/or support for any partner abuse. This item was scored with a range from 0-10. 0=not ready at all to 10=completely ready. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to use treatment, resources, or support for any partner abuse.

Time frame: Assessed at baseline, and again three months later

Population: The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.

ArmMeasureGroupValue (MEAN)Dispersion
ROSE ProgramMotivation ScaleMotivation Scale at Baseline6.18 units on a scaleStandard Deviation 2.76
ROSE ProgramMotivation ScaleMotivation Scale at Follow Up6.81 units on a scaleStandard Deviation 3.64
Control ConditionMotivation ScaleMotivation Scale at Baseline7.52 units on a scaleStandard Deviation 3.48
Control ConditionMotivation ScaleMotivation Scale at Follow Up7.22 units on a scaleStandard Deviation 3.15
Comparison: Motivation Scale at Follow Upp-value: 0.9085Wilcoxon (Mann-Whitney)
Comparison: Change in Motivation Scale from Baseline to Follow Upp-value: 0.3256Wilcoxon (Mann-Whitney)
Secondary

The Readiness to Change Contemplation Ladder

One item measure to assess readiness to make changes to increase safety. This item was scored with a range from 0-10. 0=not prepared to change to 10=already changing. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to make changes to increase safety.

Time frame: Assessed at baseline, and again three months later

Population: The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.

ArmMeasureGroupValue (MEAN)Dispersion
ROSE ProgramThe Readiness to Change Contemplation LadderReadiness at Baseline8.25 units on a scaleStandard Deviation 2.01
ROSE ProgramThe Readiness to Change Contemplation LadderReadiness at Follow Up8.00 units on a scaleStandard Deviation 2.94
Control ConditionThe Readiness to Change Contemplation LadderReadiness at Baseline8.08 units on a scaleStandard Deviation 2.68
Control ConditionThe Readiness to Change Contemplation LadderReadiness at Follow Up7.26 units on a scaleStandard Deviation 2.97
Comparison: Readiness at Follow Upp-value: 0.4085Wilcoxon (Mann-Whitney)
Comparison: Change in Readiness from Baseline to Follow Upp-value: 0.2467Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026