Intervention for IPV Perinatal Women- RCT

NCT02370394 | Completed Results DMC

• 2 other identifiers: 14-00561R21HD077358-01A1
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Intimate Partner Violence

Keywords

Intimate Partner Violence; Perinatal Women; Mental Health

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Assessed at baseline, and again three months later

Secondary Outcomes (2)

• Motivation Scale

  Assessed at baseline, and again three months later

• The Readiness to Change Contemplation Ladder

  Assessed at baseline, and again three months later

Study Arms (2)

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.

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.

Interventions

ROSE Program BEHAVIORAL

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.

ROSE Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Center for Women's Behavioral Health at Women and Infants' Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (2)

• 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.

  PMID: 32608505 DERIVED

• 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.

  PMID: 30088145 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Results Point of Contact

• Title: Caron Zlotnick, Ph.D.
• Organization: Butler Hospital/Women and Infants Hospital

CZlotnick@Butler.org

(401) 455-6529

Study Officials

• Caron Zlotnick, PhD

  Women and Infants' Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Behavioral Medicine Research

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 24, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 4, 2018
• Results First Posted: January 5, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)