Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Homeless Female Offenders Returning to the Community: Improving Hopeful Futures
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.


Options:
A: Arm Label: FEM-CARE; Type: EXPERIMENTAL; Interventions: Behavioral: FEM-CARE | Arm Label: Health Promotion; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Health Promotion | Intervention Type: BEHAVIORAL; Name: FEM-CARE; Assigned to Arm(s): FEM-CARE | Intervention Type: BEHAVIORAL; Name: Health Promotion; Assigned to Arm(s): Health Promotion
B: Arm Label: Extended-Release Naltrexone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Extended-Release Naltrexone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Extended-Release Naltrexone | Intervention Type: DRUG; Name: Extended-Release Naltrexone; Assigned to Arm(s): Extended-Release Naltrexone, Placebo
C: Arm Label: Miami Juvenile Drug Court-MDFT; Type: EXPERIMENTAL; Interventions: Behavioral: Miami Juvenile Drug Court-MDFT | Arm Label: Miami Juvenile Drug Court -TAU; Type: OTHER; Interventions: Behavioral: Miami Juvenile Drug Court -TAU | Intervention Type: BEHAVIORAL; Name: Miami Juvenile Drug Court-MDFT; Assigned to Arm(s): Miami Juvenile Drug Court-MDFT | Intervention Type: BEHAVIORAL; Name: Miami Juvenile Drug Court -TAU; Assigned to Arm(s): Miami Juvenile Drug Court -TAU
D: Arm Label: Patient Noncompliance; Type: EXPERIMENTAL; Interventions: Drug: haloperidol decanoate, Drug: haloperidol, Behavioral: Customized Adherence Enhancement | Intervention Type: DRUG; Name: haloperidol decanoate; Assigned to Arm(s): Patient Noncompliance | Intervention Type: DRUG; Name: haloperidol; Assigned to Arm(s): Patient Noncompliance | Intervention Type: BEHAVIORAL; Name: Customized Adherence Enhancement; Assigned to Arm(s): Patient Noncompliance

Answer: A