Clinical trial NCT02629133: Intervention for Battered Sheltered Women With Substance Use Randomized Trial
Official title: Computer-Based Intervention for Battered Sheltered Women With Substance Use Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Keywords: Intimate Partner Violence
Sheltered Battered Women
Substance Use
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-12-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version
timeFrame: Assessed at baseline, and at 3 and 6 months post shelter
Secondary outcomes:
measure: The Treatment Services Review (TSR)
timeFrame: Assessed at baseline, and again at 3 and 6 months later
measure: The Composite Abuse Scale (CAS)
timeFrame: Assessed at baseline, and again at 3 and 6 months after shelter release
measure: The Cyber Stalking Scale
timeFrame: Assessed at baseline, and again at 3 and 6 months later
measure: Safety Behavior Checklist (SBC)
timeFrame: Assessed at baseline, and again at 3 and 6 months after shelter release
Other outcomes:
Locations:
city: Attleboro
country: United States
facility: New Hope
state: Massachusetts
city: Akron
country: United States
facility: Battered Women's Shelter of Summit and Medina Counties
state: Ohio
city: Providence
country: United States
facility: Center for Women's Behavioral Health at Women and Infants' Hospital
state: Rhode Island
city: Woonsocket
country: United States
facility: Sojourner House
state: Rhode Island
Study officials:
affiliation: Women and Infants' Hospital
name: Caron Zlotnick, PhD
role: PRINCIPAL_INVESTIGATOR
References: