Intervention for Battered Sheltered Women With Substance Use Randomized Trial

Not Applicable

Completed

Conditions: Intimate Partner Violence

Interventions: Behavioral: SHE Program

Registration Number: NCT02629133

Lead Sponsor: Women and Infants Hospital of Rhode Island

Brief Summary: This study developed and assessed an innovative, high-reach, easily implementable, low-cost computer-delivered intervention (Safe and Healthy Experiences; The SHE Program) that addresses known barriers in early identification and intervention with sheltered battered women with IPV (intimate partner violence) and substance use.

Detailed Description: Intimate partner violence (IPV) and substance use are significant and interconnected public health problems facing women. For battered women, the presence of substance use increases the risk of revictimization and the risk of more severe abuse. Battered women's shelters provide emergency shelter to approximately 300,000 women and children each year. A prime time to intervene with battered women might be when they enter a shelter and have already initiated a change in their lives. A shelter-based intervention for battered women that addresses substance use problems might reduce the risk of substance use, reduce the risk of future IPV, and improve utilization of substance use treatment and community resources. The objective of this R34 Award was to develop and assess an innovative, easily implementable, low-cost, computer-delivered intervention, the SHE Program (Safe and Healthy Experiences) that addresses known barriers in early identification and intervention for battered sheltered women with substance use issues. SHE is based on motivational interviewing (MI) a well-defined intervention strategy that has yielded particularly promising results in a range of clinical issues and a range of patient populations, including substance using women. MI is consistent with an empowerment model, which is a highly recommended intervention model for victimized women. The R34 had two distinct phases to assess the SHE Program with battered sheltered women with substance use issues. During the Development Phase, the research team conducted focus groups and developed the intervention to meet the needs of our target group, developed the software for the computer-delivered intervention, and conducted an open trial with 10 participants. During the Pilot Study Phase, the investigators conducted a two-group, randomized controlled study with a sample of 50 battered sheltered women who reported substance use difficulties within the last three months, which provides the necessary groundwork to examine the efficacy of the SHE Program in a future, large clinical trial. The SHE Program was found to be feasible, acceptable and efficacious in improving outcomes for our vulnerable target population. The program has the potential to be widely disseminated while maintaining treatment fidelity across battered women shelters and may hold promise for IPV populations with substance use difficulties in other settings.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Women who are 18 or older, residents of a battered women's shelter, who are at risk substance users within the last 3 months as determined by the screener, the NIDA-Modified ASSIST, and endorse IPV within the last 3 months as determined by the screener, the WAST (Woman Abuse Screening Tool)

Exclusion Criteria

Inability to provide informed consent (e.g., due to florid psychosis or other clear cognitive impairment)
Inability to understand English

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHE Program	SHE Program	Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.

Primary Outcome Measures

Name	Time	Method
Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version	Assessed at baseline, and at 3 and 6 months post shelter	The computer-based TLFB will assess drug use and heavy drinking (4+ standard drinks) days for the past week and the past 90 days. For primary analysis, days using drugs and heavy drinking days will be combined to create a single variable that reflects the total number of days that women used drugs or had 4+ drinks. The primary outcome is substance use (heavy drinking or drug using) days over a 6 month post shelter period. We are assessing the change of this number from baseline to 3 months post shelter, and from baseline 6 months post shelter.

Secondary Outcome Measures

Name	Time	Method
The Treatment Services Review (TSR)	Assessed at baseline, and again at 3 and 6 months later	The Treatment Services Review will be used to assess total times using substance use services (both treatment and self-help utilization) received (including outpatient, day patient, residential treatment, NA, AA) to capture the extent to which women are reaching out to access recovery-related resources. The TSR will assess number of times attending substance use services, divided by the number of days in the reporting period.
Safety Behavior Checklist (SBC)	Assessed at baseline, and again at 3 and 6 months after shelter release	Safety Behavior Checklist (SBC) has 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Scores range from 0 to 15; higher scores are better (indicating more safety behaviors used).
The Composite Abuse Scale (CAS)	Assessed at baseline, and again at 3 and 6 months after shelter release	The CAS is a widely used self-report of behaviors scale with 4 subscales that measure severe, combined abuse, emotional abuse, physical abuse, and harassment. The CAS has recently been published in the Centers for Disease Control and Prevention compendium of intimate partner violence measures. It consists of 30 items presented in a six point format requiring respondents to answer "never", "only once", "several times", "monthly", "weekly" or "daily" in a twelve month period. Below we present the CAS victimization scores. Scores range from 0 to 145; higher scores are worse.
The Cyber Stalking Scale	Assessed at baseline, and again at 3 and 6 months later	The Cyber Stalking Scale measure is a 6 -item measure and assesses the use of technologies in stalking and harassment. Scores range from 0 to 12. Lower is better (indicated less Cyber Stalking).

Trial Locations

Locations (4): Battered Women's Shelter of Summit and Medina Counties
🇺🇸
Akron, Ohio, United States
Center for Women's Behavioral Health at Women and Infants' Hospital
🇺🇸
Providence, Rhode Island, United States
Sojourner House
🇺🇸
Woonsocket, Rhode Island, United States
New Hope
🇺🇸
Attleboro, Massachusetts, United States