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Homeless Female Offenders Returning to the Community (FEM-CARE)

Primary Purpose

Drug Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FEM-CARE
Health Promotion
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Drug Addiction focused on measuring Homeless Women, Parolees, Probationers, Community Drug Treatment, Recidivism

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female parolees or probationers enrolled in a six-month program at one of two residential treatment (RDT) programs,
  • convicted for a drug crime, and
  • reported homeless on their RDT entry form

Exclusion Criteria:

  • female parolees or probationers not currently enrolled in a six-month program at one of two residential treatment (RDT) programs,
  • not recently convicted for a drug crime, and
  • not reported homeless on their RDT entry form

Sites / Locations

  • Amistad de Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FEM-CARE

Health Promotion

Arm Description

Six specialized nurse case managed and health education sessions and coach-facilitated mentoring

One brief basic health education session and coach-facilitated mentoring

Outcomes

Primary Outcome Measures

Primary Outcome Measure
Reduction in drug and alcohol use

Secondary Outcome Measures

Secondary Outcome Measure
Number of visits to health care or social service providers

Full Information

First Posted
October 2, 2014
Last Updated
June 16, 2017
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02258425
Brief Title
Homeless Female Offenders Returning to the Community
Acronym
FEM-CARE
Official Title
Homeless Female Offenders Returning to the Community: Improving Hopeful Futures
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In Phase I of this R34, the team from the University of California Los Angeles, San Francisco, and Irvine researchers plan to utilize the successful community participatory approaches to refine a gender-sensitive criminogenic needs -focused intervention program, Female Ex-Offender Mentoring in Care (FEM-CARE), with the help of a community advisory board, composed of homeless female offenders (HFOs) and addiction staff; and finalize strategies which will be validated by focus group sessions with the HFOs. In Phase 2, the research team will randomize 130 HFOs participating in one of two residential drug treatment programs to assess the impact of the FEM-CARE or a Health Promotion control program on reduction of drug and alcohol use and recidivism. This study is based upon our team's history of promoting theoretically-based, culturally sensitive nurse-led interventions that are enriched with criminal justice theoretical perspectives, and have resulted in significant reductions in drug and alcohol use among homeless persons, many of whom have had a history of incarceration. Specifically, the study aims are: AIM 1) Guided by a Community Advisory Board (CAB) made up of HFOs and addiction staff, further conceptualize our community-based program, Female Ex-Offender Mentoring in Care (FEM-CARE), to address the needs and risks of HFOs enrolled in RDT programs, and then refine the program in focus group discussions with 12 HFOs. AIM 2) Conduct a pilot RCT to assess the impact of the FEM-CARE program for 65 HFOs at six-month follow-up compared with 65 HFOs receiving a control Health Promotion (HP) program, in terms of a) self-reported and/or objective measures of drug and alcohol use; and b) prevalence of recidivism and number of days to first reincarceration. Hypothesis 2a: HFOs in the FEM-CARE program will have less drug and alcohol use at six months than HFOs in the HP control program. Hypothesis 2b: FEM-CARE HFOs will have a lower prevalence of recidivism by six months and greater number of days to first reincarceration than HP control HFOs.
Detailed Description
In the last decade, the numbers of incarcerated females has tripled, making women the most rapidly growing group of offenders in the United States. When compared to incarcerated males, female offenders have a higher rate of being sentenced for drug crimes; moreover, they are often injection drug users (IDUs), have sexual partners who are IDUs, and are often forced into the sex trade for survival. As many as 50% of female offenders report physical and/or sexual abuse; further, traumatic abuse, chronic emotional distress, and internalized stigma resulting from being a felon and a drug-user, have a profound effect on the women's self-esteem, leading to feelings of hopelessness and depression, delayed recovery and reintegration, increased risky behaviors, and health concerns. Not surprisingly, women who have been incarcerated are nearly twice as likely to experience mental illness compared with non-offending women; further, 44% recidivate within a year due to possession of a controlled substance. In particular, among homeless female offenders (HFOs), both parolees and probationers report ongoing challenges for successful re-entry. These include unstable housing, disorganized lives, unemployment, and limited access to health and social services. While the Los Angeles County Department of Probation has provided guidance for successful programs in its California Blueprint Master Plan for Female Offenders, the suggested strategies of enhancing empowerment, positive coping, and job skills, and providing peer-mentored approaches have not yet been implemented or evaluated. In Phase I of this R34, our team of University of California Los Angeles, San Francisco, and Irvine researchers plan to utilize our successful community participatory approaches to refine a gender-sensitive criminogenic needs -focused intervention program, Female Ex-Offender Mentoring in Care (FEM-CARE), with the help of a community advisory board, composed of HFOs and addiction staff; and finalize strategies which will be validated by focus group sessions with HFOs. In Phase 2, we will randomize 130 HFOs participating in one of two residential drug treatment programs to assess the impact of the FEM-CARE or a Health Promotion control program on reduction of drug and alcohol use and recidivism. This study is based upon our team's history of promoting theoretically-based, culturally sensitive nurse-led interventions that are enriched with criminal justice theoretical perspectives, and have resulted in significant reductions in drug and alcohol use among homeless persons, many of whom have had a history of incarceration. Our most recent successes in engaging male parolees in nurse-supported peer mentorship, our team's expertise in enhancing stigma reduction among vulnerable women, and our criminal justice experts have informed this study. Finally, recent formative research with HFOs has revealed a desire for peer role models to support and enhance knowledge of and access to healthcare, promote positive coping, stable housing, and job skills, and to reduce stigma and depressed mood; all of these factors can result in novel programs designed to prevent drug and alcohol use and reduce recidivism. This foundation and strong community support garnered has led to the design of our proposed intervention program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Addiction
Keywords
Homeless Women, Parolees, Probationers, Community Drug Treatment, Recidivism

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FEM-CARE
Arm Type
Experimental
Arm Description
Six specialized nurse case managed and health education sessions and coach-facilitated mentoring
Arm Title
Health Promotion
Arm Type
Active Comparator
Arm Description
One brief basic health education session and coach-facilitated mentoring
Intervention Type
Behavioral
Intervention Name(s)
FEM-CARE
Intervention Type
Behavioral
Intervention Name(s)
Health Promotion
Primary Outcome Measure Information:
Title
Primary Outcome Measure
Description
Reduction in drug and alcohol use
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Secondary Outcome Measure
Description
Number of visits to health care or social service providers
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female parolees or probationers enrolled in a six-month program at one of two residential treatment (RDT) programs, convicted for a drug crime, and reported homeless on their RDT entry form Exclusion Criteria: female parolees or probationers not currently enrolled in a six-month program at one of two residential treatment (RDT) programs, not recently convicted for a drug crime, and not reported homeless on their RDT entry form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeline Nyamathi, PhD
Organizational Affiliation
UCLA/UCI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amistad de Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27195929
Citation
Nyamathi AM, Srivastava N, Salem BE, Wall S, Kwon J, Ekstrand M, Hall E, Turner SF, Faucette M. Female Ex-Offender Perspectives on Drug Initiation, Relapse, and Desire to Remain Drug Free. J Forensic Nurs. 2016 Apr-Jun;12(2):81-90. doi: 10.1097/JFN.0000000000000110.
Results Reference
background
PubMed Identifier
28152325
Citation
Nyamathi AM, Salem BE, Hall E, Oleskowicz T, Ekstrand M, Yadav K, Toyama J, Turner S, Faucette M. Violent Crime in the Lives of Homeless Female Ex-Offenders. Issues Ment Health Nurs. 2017 Feb;38(2):122-131. doi: 10.1080/01612840.2016.1253807. Epub 2017 Feb 2.
Results Reference
background
PubMed Identifier
29095374
Citation
Nyamathi AM, Shin SS, Smeltzer J, Salem BE, Yadav K, Ekstrand ML, Turner SF, Faucette M. Achieving Drug and Alcohol Abstinence Among Recently Incarcerated Homeless Women: A Randomized Controlled Trial Comparing Dialectical Behavioral Therapy-Case Management With a Health Promotion Program. Nurs Res. 2017 Nov/Dec;66(6):432-441. doi: 10.1097/NNR.0000000000000249.
Results Reference
derived

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Homeless Female Offenders Returning to the Community

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