<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02258425</url>
  </required_header>
  <id_info>
    <org_study_id>1R34DA035409</org_study_id>
    <nct_id>NCT02258425</nct_id>
  </id_info>
  <brief_title>Homeless Female Offenders Returning to the Community</brief_title>
  <acronym>FEM-CARE</acronym>
  <official_title>Homeless Female Offenders Returning to the Community: Improving Hopeful Futures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Phase I of this R34, the team from the University of California Los Angeles, San&#xD;
      Francisco, and Irvine researchers plan to utilize the successful community participatory&#xD;
      approaches to refine a gender-sensitive criminogenic needs -focused intervention program,&#xD;
      Female Ex-Offender Mentoring in Care (FEM-CARE), with the help of a community advisory board,&#xD;
      composed of homeless female offenders (HFOs) and addiction staff; and finalize strategies&#xD;
      which will be validated by focus group sessions with the HFOs. In Phase 2, the research team&#xD;
      will randomize 130 HFOs participating in one of two residential drug treatment programs to&#xD;
      assess the impact of the FEM-CARE or a Health Promotion control program on reduction of drug&#xD;
      and alcohol use and recidivism. This study is based upon our team's history of promoting&#xD;
      theoretically-based, culturally sensitive nurse-led interventions that are enriched with&#xD;
      criminal justice theoretical perspectives, and have resulted in significant reductions in&#xD;
      drug and alcohol use among homeless persons, many of whom have had a history of&#xD;
      incarceration.&#xD;
&#xD;
      Specifically, the study aims are:&#xD;
&#xD;
      AIM 1) Guided by a Community Advisory Board (CAB) made up of HFOs and addiction staff,&#xD;
      further conceptualize our community-based program, Female Ex-Offender Mentoring in Care&#xD;
      (FEM-CARE), to address the needs and risks of HFOs enrolled in RDT programs, and then refine&#xD;
      the program in focus group discussions with 12 HFOs.&#xD;
&#xD;
      AIM 2) Conduct a pilot RCT to assess the impact of the FEM-CARE program for 65 HFOs at&#xD;
      six-month follow-up compared with 65 HFOs receiving a control Health Promotion (HP) program,&#xD;
      in terms of a) self-reported and/or objective measures of drug and alcohol use; and b)&#xD;
      prevalence of recidivism and number of days to first reincarceration.&#xD;
&#xD;
      Hypothesis 2a: HFOs in the FEM-CARE program will have less drug and alcohol use at six months&#xD;
      than HFOs in the HP control program.&#xD;
&#xD;
      Hypothesis 2b: FEM-CARE HFOs will have a lower prevalence of recidivism by six months and&#xD;
      greater number of days to first reincarceration than HP control HFOs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the last decade, the numbers of incarcerated females has tripled, making women the most&#xD;
      rapidly growing group of offenders in the United States. When compared to incarcerated males,&#xD;
      female offenders have a higher rate of being sentenced for drug crimes; moreover, they are&#xD;
      often injection drug users (IDUs), have sexual partners who are IDUs, and are often forced&#xD;
      into the sex trade for survival. As many as 50% of female offenders report physical and/or&#xD;
      sexual abuse; further, traumatic abuse, chronic emotional distress, and internalized stigma&#xD;
      resulting from being a felon and a drug-user, have a profound effect on the women's&#xD;
      self-esteem, leading to feelings of hopelessness and depression, delayed recovery and&#xD;
      reintegration, increased risky behaviors, and health concerns. Not surprisingly, women who&#xD;
      have been incarcerated are nearly twice as likely to experience mental illness compared with&#xD;
      non-offending women; further, 44% recidivate within a year due to possession of a controlled&#xD;
      substance. In particular, among homeless female offenders (HFOs), both parolees and&#xD;
      probationers report ongoing challenges for successful re-entry. These include unstable&#xD;
      housing, disorganized lives, unemployment, and limited access to health and social services.&#xD;
      While the Los Angeles County Department of Probation has provided guidance for successful&#xD;
      programs in its California Blueprint Master Plan for Female Offenders, the suggested&#xD;
      strategies of enhancing empowerment, positive coping, and job skills, and providing&#xD;
      peer-mentored approaches have not yet been implemented or evaluated. In Phase I of this R34,&#xD;
      our team of University of California Los Angeles, San Francisco, and Irvine researchers plan&#xD;
      to utilize our successful community participatory approaches to refine a gender-sensitive&#xD;
      criminogenic needs -focused intervention program, Female Ex-Offender Mentoring in Care&#xD;
      (FEM-CARE), with the help of a community advisory board, composed of HFOs and addiction&#xD;
      staff; and finalize strategies which will be validated by focus group sessions with HFOs. In&#xD;
      Phase 2, we will randomize 130 HFOs participating in one of two residential drug treatment&#xD;
      programs to assess the impact of the FEM-CARE or a Health Promotion control program on&#xD;
      reduction of drug and alcohol use and recidivism. This study is based upon our team's history&#xD;
      of promoting theoretically-based, culturally sensitive nurse-led interventions that are&#xD;
      enriched with criminal justice theoretical perspectives, and have resulted in significant&#xD;
      reductions in drug and alcohol use among homeless persons, many of whom have had a history of&#xD;
      incarceration. Our most recent successes in engaging male parolees in nurse-supported peer&#xD;
      mentorship, our team's expertise in enhancing stigma reduction among vulnerable women, and&#xD;
      our criminal justice experts have informed this study. Finally, recent formative research&#xD;
      with HFOs has revealed a desire for peer role models to support and enhance knowledge of and&#xD;
      access to healthcare, promote positive coping, stable housing, and job skills, and to reduce&#xD;
      stigma and depressed mood; all of these factors can result in novel programs designed to&#xD;
      prevent drug and alcohol use and reduce recidivism. This foundation and strong community&#xD;
      support garnered has led to the design of our proposed intervention program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Outcome Measure</measure>
    <time_frame>3 years</time_frame>
    <description>Reduction in drug and alcohol use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome Measure</measure>
    <time_frame>3 years</time_frame>
    <description>Number of visits to health care or social service providers</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Drug Addiction</condition>
  <arm_group>
    <arm_group_label>FEM-CARE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Six specialized nurse case managed and health education sessions and coach-facilitated mentoring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Promotion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One brief basic health education session and coach-facilitated mentoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FEM-CARE</intervention_name>
    <arm_group_label>FEM-CARE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Promotion</intervention_name>
    <arm_group_label>Health Promotion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female parolees or probationers enrolled in a six-month program at one of two&#xD;
             residential treatment (RDT) programs,&#xD;
&#xD;
          -  convicted for a drug crime, and&#xD;
&#xD;
          -  reported homeless on their RDT entry form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  female parolees or probationers not currently enrolled in a six-month program at one&#xD;
             of two residential treatment (RDT) programs,&#xD;
&#xD;
          -  not recently convicted for a drug crime, and&#xD;
&#xD;
          -  not reported homeless on their RDT entry form&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adeline Nyamathi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA/UCI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amistad de Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>27195929</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28152325</PMID>
  </reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>June 16, 2017</last_update_submitted>
  <last_update_submitted_qc>June 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Adeline Nyamathi, PhD</investigator_full_name>
    <investigator_title>Distinguished Professor</investigator_title>
  </responsible_party>
  <keyword>Homeless Women</keyword>
  <keyword>Parolees</keyword>
  <keyword>Probationers</keyword>
  <keyword>Community Drug Treatment</keyword>
  <keyword>Recidivism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02258425
org study id: 1R34DA035409
nct id: NCT02258425
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Primary Outcome Measure
time frame: 3 years
description: Reduction in drug and alcohol use
measure: Secondary Outcome Measure
time frame: 3 years
description: Number of visits to health care or social service providers
arm group label: FEM-CARE
arm group type: Experimental
description: Six specialized nurse case managed and health education sessions and coach-facilitated mentoring
arm group label: Health Promotion
arm group type: Active Comparator
description: One brief basic health education session and coach-facilitated mentoring
intervention type: Behavioral
intervention name: FEM-CARE
arm group label: FEM-CARE
intervention type: Behavioral
intervention name: Health Promotion
arm group label: Health Promotion
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Adeline Nyamathi, PhD
role: Principal Investigator
affiliation: UCLA/UCI
facility: 
country: United States
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.
PMID: 27195929
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.
PMID: 28152325
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Adeline Nyamathi, PhD
investigator title: Distinguished Professor
mesh term: Substance-Related Disorders
sharing ipd: No