Drug AddictionFEM-CARENCT02258425
Homeless Female Offenders Returning to the Community
A study testing FEM-CARE and Health Promotion in people with Drug Addiction, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Drug Addiction
- What is being tested?
- FEM-CARE and Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Amistad de Los Angeles
Los Angeles, California, 90007
About this study
Official title: Homeless Female Offenders Returning to the Community: Improving Hopeful Futures
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:
Read more
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.
Read the 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.
- Conditions
- Drug Addiction
- Being tested
- FEM-CARE, Health Promotion
- Keywords
- Homeless Women, Parolees, Probationers, Community Drug Treatment, Recidivism
- Medical subject headings
- Substance-Related Disorders, Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEM-CAREBehavioural
Health PromotionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| FEM-CARE | Experimental | Six specialized nurse case managed and health education sessions and coach-facilitated mentoring Receives: Behavioral: FEM-CARE |
| Health Promotion | Active comparator | One brief basic health education session and coach-facilitated mentoring Receives: Behavioral: Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Reduction in drug and alcohol use
Measured: 3 years
Secondary outcomes (1)
Secondary Outcome Measure
Number of visits to health care or social service providers
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeline Nyamathi, PhD, University of California, Los Angeles
- Investigators
- Adeline Nyamathi, PhD, Principal investigator, UCLA/UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258425
- Sponsor's protocol ID
- 1R34DA035409
- Acronym
- FEM-CARE
- Status last verified
- Jun 2017
- First submitted
- 2 Oct 2014
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27195929Nyamathi 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.
PubMed 28152325Nyamathi 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.
PubMed 29095374
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeless Female Offenders Returning to the Community: Improving Hopeful Futures
- ClinicalTrials.gov ID
- NCT02258425
- Acronym / sponsor ID
- FEM-CARE / 1R34DA035409
- Conditions
- Drug Addiction
- Keywords
- Homeless Women, Parolees, Probationers, Community Drug Treatment, Recidivism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FEM-CARE | Experimental | Behavioral: FEM-CARESix specialized nurse case managed and health education sessions and coach-facilitated mentoring |
| Health Promotion | Active comparator | Behavioral: Health PromotionOne brief basic health education session and coach-facilitated mentoring |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEM-CARE | Behavioural | FEM-CARE |
| Health Promotion | Behavioural | Health Promotion |
Primary outcome
Primary Outcome Measure
Time frame: 3 years
Reduction in drug and alcohol use
1 secondary outcome
Secondary Outcome Measure
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Background: PubMed 27195929Nyamathi 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.
- Background: PubMed 28152325Nyamathi 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.
- Derived from this study: PubMed 29095374Nyamathi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline Nyamathi, PhD principal investigator
UCLA/UCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEM-CARE and Health Promotion in people with Drug Addiction, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02258425, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.