Drug Addiction Clinical Trial
— FEM-CAREOfficial title:
Homeless Female Offenders Returning to the Community: Improving Hopeful Futures
Verified date | June 2017 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Amistad de Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Outcome Measure | Reduction in drug and alcohol use | 3 years | |
Secondary | Secondary Outcome Measure | Number of visits to health care or social service providers | 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02939352 -
The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues
|
Early Phase 1 | |
Completed |
NCT02192931 -
A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users
|
Phase 4 | |
Completed |
NCT02437123 -
The Cedar Project: Impact of mHealth for HIV Prevention Among Young Indigenous People Who Use Illicit Drugs
|
N/A | |
Completed |
NCT02224508 -
Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
|
N/A | |
Completed |
NCT02282306 -
Phone Interview to Prevent Recurring Opioid Overdoses
|
N/A | |
Completed |
NCT01685073 -
The Role of Sleep in the Treatment of Cannabis Use Disorders
|
Phase 2/Phase 3 | |
Completed |
NCT01591239 -
Home-Based Program to Help Parents of Drug Abusing Adolescents
|
N/A | |
Completed |
NCT00317460 -
Buprenorphine and Integrated HIV Care
|
Phase 4 | |
Completed |
NCT03678051 -
CBT4CBT for Women in Residential Treatment for Substance Use Disorders
|
N/A | |
Completed |
NCT04105621 -
Westlake Personalized Nutrition and Health Cohort for Drug Addicts
|
||
Withdrawn |
NCT05440721 -
Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
|
N/A | |
Completed |
NCT03694327 -
Innovative Digital Therapeutic for Smoking Cessation
|
N/A | |
Completed |
NCT00244699 -
Integrating Mindfulness-Based Skills Training Into Brief Outpatient Treatment for Substance Abusing Youth
|
N/A | |
Completed |
NCT00496990 -
Treating the Partners of Drug Using Pregnant Women: Stage II
|
Phase 2/Phase 3 | |
Completed |
NCT00390559 -
Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3
|
N/A | |
Completed |
NCT03411265 -
RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing
|
N/A | |
Completed |
NCT03402672 -
AWAITS: A Web-based E-health Application for Active Illicit Opioid Users
|
N/A | |
Completed |
NCT01003496 -
Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial
|
Phase 3 | |
Completed |
NCT02091284 -
Bilateral Prefrontal Modulation in Alcoholism
|
N/A | |
Completed |
NCT02091167 -
Bilateral Prefrontal Modulation in Crack-cocaine Addiction
|
Phase 2 |