Substance Abuse and Trauma in Incarcerated Women

March 17, 2014 updated by: Rachael Swopes, University of Tulsa

Substance Abuse and Trauma in Incarcerated Women: An Effectiveness Study

The proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft, Oklahoma. The purpose of the proposed study is to expand previous findings by including a comparison group of women that are not receiving treatment but are otherwise eligible, and by using outside evaluators to conduct the assessments. Furthermore, this study will extend the outcomes measured in previous evaluations by including measures of sleep disturbance, posttraumatic cognitions, and a more extensive assessment of trauma-related symptoms. The hypotheses for this study are listed below:

  1. Incarcerated women with substance use disorders and history of trauma enrolled in the integrated treatment program (HWR plus BT) will report significantly fewer symptoms on measures of posttraumatic stress and associated cognitions, substance use, depression, and related symptoms following treatment than those in the comparison group.
  2. Those in the treatment group will improve significantly more than those in the comparison group on the symptoms listed above.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Taft, Oklahoma, United States, 74463
        • Eddie Warrior Correctional Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Incarcerated women at Eddie Warrior Correctional Center (EWCC) in Taft, Oklahoma

  • The following 6 criteria are then employed at EWCC for HWR/BT treatment eligibility:

    1. An Level of Service Inventory (LSI) score of 30 or greater
    2. An LSI protective score of 15 or less
    3. 1.5 years or less remaining in prison
    4. A Case Plan identifying substance abuse treatment need
    5. Ability to read and comprehend
    6. 18 years of age or older

Exclusion Criteria:

  • Under age 18
  • Not incarcerated
  • More than 1.5 years remaining in prison
  • LSI score less than 30 or a protective of more than 15
  • No identified substance abuse need
  • Inability to read and comprehend

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cognitive behavioral group treatment
Helping Women Recover/Beyond Trauma integrated substance abuse and trauma treatment group. (Dr. Covington)
Behavioral: Helping Women Recover/Beyond Trauma
Four treatment rounds will be conducted, and a goal of 20 women (10 from each group) will be recruited to participate in each round. A new treatment group will start every four months. Sessions are approximately 2 hours each, 3-4 times per week over four months in a group format. This treatment program will focus on the integrated treatment of trauma and substance abuse in women. Versions of the curriculum exist both for community and corrections populations. In this intervention the corrections version will be used.
No Intervention: comparison group
a comparison group of incarcerated women will receive the pre and post assessments with no interventions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PTSD checklist (change from baseline at one week post treatment)
Time Frame: one-week before treatment, one week post treatment
17 item post traumatic stress disorder symptoms checklist will be administered pre treatment and one week following 4 month treatment completion.
one-week before treatment, one week post treatment
Trauma Related Nightmare Survey (change from baseline at one week post treatment)
Time Frame: one week before treatment, one week post treatment
brief assessment of nightmare frequency and severity to be administered pre-treatment and one week following 4 month treatment completion.
one week before treatment, one week post treatment
Posttraumatic Cognitions Inventory (change from baseline at one week post treatment)
Time Frame: one week before treatment, one week post treatment
36 item assesment of cognitions related to world, self and blame to be administered pre-treatment and one week following 4 month treatment completion.
one week before treatment, one week post treatment
CES-D, NIMH (change from baseline at one week post treatment)
Time Frame: one week before treatment, one week post treatment
Center for Epidemiologic Studies Depression Scale (CES-D), NIMH is a 20 item depression inventory to be administered pre-treatment and one week following 4 month treatment completion.
one week before treatment, one week post treatment
Drug-Taking Confidence Questionnaire (change from baseline at one week post treatment)
Time Frame: one week before treatment, one week post treatment
50 item assessment of alcohol and drugs self efficacy to be administered pre-treatment and one week following 4 month treatment completion.
one week before treatment, one week post treatment
Trauma Symptoms Inventory (change from baseline at one week post treatment)
Time Frame: one week before treatment, one week post treatment
100 item trauma symptoms questionnaire to be administered pre-treatment and one week following 4 month treatment completion.
one week before treatment, one week post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parenting Stress Index for Incarcerated Women (change from baseline at one week post treatment)
Time Frame: one week before treatment, one week post treatment
two scales from the PSI and selected parenting issues from incarcerated women to be administered pre-treatment and one week following 4 month treatment completion.
one week before treatment, one week post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Tulsa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachael Swopes, M.S., University of Tulsa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TU 11-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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