Intervention for Battered Sheltered Women With Substance Use Randomized Trial

NCT02629133 | Completed Results DMC

• 2 other identifiers: 792696R34DA038770-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Intimate Partner Violence

Keywords

Intimate Partner Violence; Sheltered Battered Women; Substance Use

Outcome Measures

Primary Outcomes (1)

• Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version

  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.

  Assessed at baseline, and at 3 and 6 months post shelter

Secondary Outcomes (4)

• The Treatment Services Review (TSR)

  Assessed at baseline, and again at 3 and 6 months later

• The Composite Abuse Scale (CAS)

  Assessed at baseline, and again at 3 and 6 months after shelter release

• The Cyber Stalking Scale

  Assessed at baseline, and again at 3 and 6 months later

• Safety Behavior Checklist (SBC)

  Assessed at baseline, and again at 3 and 6 months after shelter release

Study Arms (2)

SHE Program

EXPERIMENTAL

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.

Behavioral: SHE Program

Control Condition

NO INTERVENTION

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 rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.

Interventions

SHE Program BEHAVIORAL

The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.

SHE Program

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

New Hope

Attleboro, Massachusetts, 02703, United States

Location

Battered Women's Shelter of Summit and Medina Counties

Akron, Ohio, 44305, United States

Location

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

Providence, Rhode Island, 02905, United States

Location

Sojourner House

Woonsocket, Rhode Island, 02895, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Caron Zlotnick
• Organization: Womene and Infants Hospital

czlotnick@butler.org

401-474-3332

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Behavioral Medicine Research

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 14, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 8, 2020
• Results First Posted: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)