Intimate Partner ViolenceNCT02370394

Intervention for IPV Perinatal Women- RCT

A study testing ROSE Program in people with Intimate Partner Violence, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Intimate Partner Violence
What is being tested?: ROSE Program
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: Mar 2015to Sep 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Women's Behavioral Health at Women and Infants' Hospital
Providence, Rhode Island, 02905

Other trials in United States

About this study

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

Read the 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.

Conditions: Intimate Partner Violence
Being tested: ROSE Program
Keywords: Intimate Partner Violence, Perinatal Women, Mental Health
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ROSE ProgramBehavioural
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.

Study groups in NCT02370394
Study group	Role	What they receive
ROSE Program	Experimental	Participants received a 35-40-minute intervention on the Tablet PC and an in-person 10-15-minute booster session conducted by interventionists within a month after the intervention. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later. Receives: Behavioral: ROSE Program
Control Condition	No intervention	Control Condition consisted of a series of questions regarding television show preferences and then viewed 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Assessed at baseline, and again three months later
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.
Measured: Assessed at baseline, and again three months later
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.
Measured: Assessed at baseline, and again three months later

Secondary outcomes (2)

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.
Measured: Assessed at baseline, and again three months later
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.
Measured: Assessed at baseline, and again three months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Sep 2016

First posted24 Feb 2015 (estimated)
Study startMar 2015
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02370394
Sponsor's protocol ID: 14-0056
Other IDs: 1R21HD077358-01A1
Status last verified: May 2018
First submitted: 17 Feb 2015
Last updated: 4 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
PubMed 32608505
Zlotnick C, Tzilos Wernette G, Raker CA. A randomized controlled trial of a computer-based brief intervention for victimized perinatal women seeking mental health treatment. Arch Womens Ment Health. 2019 Jun;22(3):315-325. doi: 10.1007/s00737-018-0895-1. Epub 2018 Aug 7.
PubMed 30088145

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
Recruiting
Adjunctive Motivational Alcohol Intervention to Prevent IPV
Alcohol Use and Intimate Partner Violence
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SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)
Recruiting
RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
Intimate Partner Violence (IPV)
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders

All Intimate Partner Violence trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Computer-Based Intervention for Victimized Perinatal Women With Mental Illness (Phase 1)
ClinicalTrials.gov ID: NCT02370394
Acronym / sponsor ID: 14-0056
Conditions: Intimate Partner Violence
Keywords: Intimate Partner Violence, Perinatal Women, Mental Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Women and Infants Hospital of Rhode IslandUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Mar 2015
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 24 Feb 2015 (estimated)
Results: Posted 5 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ROSE Program	Experimental	Behavioral: ROSE ProgramParticipants received a 35-40-minute intervention on the Tablet PC and an in-person 10-15-minute booster session conducted by interventionists within a month after the intervention. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
Control Condition	No intervention	–Control Condition consisted of a series of questions regarding television show preferences and then viewed 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ROSE ProgramThe 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.	Behavioural	ROSE Program

Primary outcome

Composite Abuse Scale (CAS)-CAS Victimization Total Score
Time frame: Assessed at baseline, and again three months later
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.
Safety Behavior Checklist (SBC)
Time frame: Assessed at baseline, and again three months later
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.
Effectiveness in Obtaining Resources Scale (EOR)
Time frame: Assessed at baseline, and again three months later
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.

2 secondary outcomes

Motivation Scale
Time frame: Assessed at baseline, and again three months later
The Readiness to Change Contemplation Ladder
Time frame: Assessed at baseline, and again three months later

Results and safety

Results posted to the registry on 5 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ROSE Program	28	26
Control Condition	25	23

Primary outcome: Composite Abuse Scale (CAS)-CAS Victimization Total Score

Time frame: Assessed at baseline, and again three months later. Mean (Standard Deviation). Unit: units on a scale

Measure	ROSE Program n = 28	Control Condition n = 25
CAS at Baseline	26.36 (17.81)	16.56 (12.25)
CAS at Follow-up	12.38 (12.44)	16.52 (20.23)

ROSE Program vs Control Condition: Mean Difference (Final Values): -4.14 (95% CI -14.02 to 5.75), p = 0.4016, t-test, 2 sided
ROSE Program vs Control Condition: Mean Difference (Net): 14.46 (95% CI 4.11 to 24.82), p = 0.0072, t-test, 2 sided

Population analysed: 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.

Primary outcome: Safety Behavior Checklist (SBC)

Time frame: Assessed at baseline, and again three months later. Mean (Standard Deviation). Unit: units on a scale

Measure	ROSE Program n = 28	Control Condition n = 25
SBC at Baseline	.28 (.23)	.36 (.23)
SBC at Follow Up	.28 (.28)	.32 (.29)

ROSE Program vs Control Condition: Mean Difference (Final Values): -0.04 (95% CI -0.21 to 0.12), p = 0.6011, t-test, 2 sided
ROSE Program vs Control Condition: Mean Difference (Net): -0.01 (95% CI -0.16 to 0.15), p = 0.9116, t-test, 2 sided

Primary outcome: Effectiveness in Obtaining Resources Scale (EOR)

Time frame: Assessed at baseline, and again three months later. Mean (Standard Deviation). Unit: units on a scale

Measure	ROSE Program n = 28	Control Condition n = 25
EOR at Baseline	2.46 (1.71)	3.48 (2.87)
EOR at Follow Up	3.31 (2.59)	3.43 (2.59)

ROSE Program vs Control Condition: Mean Difference (Final Values): -0.13 (95% CI -1.62 to 1.36), p = 0.8646, t-test, 2 sided
ROSE Program vs Control Condition: Mean Difference (Net): -0.86 (95% CI -2.54 to 0.82), p = 0.3045, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected between the date of the baseline and the 3 month follow-up, generally for 3 months, depending on when the participant's 3 month follow-up actually occurred.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ROSE Program	9 of 28 (32.1%)	0 of 28 (0%)	0 of 28
Control Condition	6 of 25 (24%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32608505Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
Derived from this study: PubMed 30088145Zlotnick C, Tzilos Wernette G, Raker CA. A randomized controlled trial of a computer-based brief intervention for victimized perinatal women seeking mental health treatment. Arch Womens Ment Health. 2019 Jun;22(3):315-325. doi: 10.1007/s00737-018-0895-1. Epub 2018 Aug 7.
Individual participant dataSharing planned: No

Related trials for Intimate Partner Violence

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Caron Zlotnick, PhD principal investigator

Women and Infants' Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ROSE Program in people with Intimate Partner Violence, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Abuse Scale (CAS)-CAS Victimization Total Score (time frame: Assessed at baseline, and again three months later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02370394, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.