NCT02258425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

October 2, 2014

Last Update Submit

June 16, 2017

Conditions

Keywords

Homeless WomenParoleesProbationersCommunity Drug TreatmentRecidivism

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    Reduction in drug and alcohol use

    3 years

Secondary Outcomes (1)

  • Secondary Outcome Measure

    3 years

Study Arms (2)

FEM-CARE

EXPERIMENTAL

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

Behavioral: FEM-CARE

Health Promotion

ACTIVE COMPARATOR

One brief basic health education session and coach-facilitated mentoring

Behavioral: Health Promotion

Interventions

FEM-CAREBEHAVIORAL
FEM-CARE
Health Promotion

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amistad de Los Angeles

Los Angeles, California, 90007, United States

Location

Related Publications (3)

  • 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.

    PMID: 27195929BACKGROUND
  • 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.

    PMID: 28152325BACKGROUND
  • 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.

MeSH Terms

Conditions

Substance-Related DisordersRecidivism

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCriminal BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Adeline Nyamathi, PhD

    UCLA/UCI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 7, 2014

Study Start

January 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations