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Substance Abuse and Trauma in Incarcerated Women

Primary Purpose

Substance Abuse, Trauma, Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helping Women Recover/Beyond Trauma
Sponsored by
University of Tulsa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Trauma, incarceration, treatment, substance abuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Eddie Warrior Correctional Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cognitive behavioral group treatment

comparison group

Arm Description

Helping Women Recover/Beyond Trauma integrated substance abuse and trauma treatment group. (Dr. Covington)

a comparison group of incarcerated women will receive the pre and post assessments with no interventions.

Outcomes

Primary Outcome Measures

PTSD checklist (change from baseline at 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.
Trauma Related Nightmare Survey (change from baseline at one week post treatment)
brief assessment of nightmare frequency and severity to be administered pre-treatment and one week following 4 month treatment completion.
Posttraumatic Cognitions Inventory (change from baseline at 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.
CES-D, NIMH (change from baseline at 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.
Drug-Taking Confidence Questionnaire (change from baseline at 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.
Trauma Symptoms Inventory (change from baseline at one week post treatment)
100 item trauma symptoms questionnaire to be administered pre-treatment and one week following 4 month treatment completion.

Secondary Outcome Measures

Parenting Stress Index for Incarcerated Women (change from baseline at 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.

Full Information

First Posted
August 3, 2011
Last Updated
March 17, 2014
Sponsor
University of Tulsa
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1. Study Identification

Unique Protocol Identification Number
NCT01413984
Brief Title
Substance Abuse and Trauma in Incarcerated Women
Official Title
Substance Abuse and Trauma in Incarcerated Women: An Effectiveness Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tulsa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: 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. Those in the treatment group will improve significantly more than those in the comparison group on the symptoms listed above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Trauma, Post Traumatic Stress Disorder, Integrated Treatment, Incarcerated Women
Keywords
Trauma, incarceration, treatment, substance abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cognitive behavioral group treatment
Arm Type
Experimental
Arm Description
Helping Women Recover/Beyond Trauma integrated substance abuse and trauma treatment group. (Dr. Covington)
Arm Title
comparison group
Arm Type
No Intervention
Arm Description
a comparison group of incarcerated women will receive the pre and post assessments with no interventions.
Intervention Type
Behavioral
Intervention Name(s)
Helping Women Recover/Beyond Trauma
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD checklist (change from baseline at one week post treatment)
Description
17 item post traumatic stress disorder symptoms checklist will be administered pre treatment and one week following 4 month treatment completion.
Time Frame
one-week before treatment, one week post treatment
Title
Trauma Related Nightmare Survey (change from baseline at one week post treatment)
Description
brief assessment of nightmare frequency and severity to be administered pre-treatment and one week following 4 month treatment completion.
Time Frame
one week before treatment, one week post treatment
Title
Posttraumatic Cognitions Inventory (change from baseline at one week post treatment)
Description
36 item assesment of cognitions related to world, self and blame to be administered pre-treatment and one week following 4 month treatment completion.
Time Frame
one week before treatment, one week post treatment
Title
CES-D, NIMH (change from baseline at one week post treatment)
Description
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.
Time Frame
one week before treatment, one week post treatment
Title
Drug-Taking Confidence Questionnaire (change from baseline at one week post treatment)
Description
50 item assessment of alcohol and drugs self efficacy to be administered pre-treatment and one week following 4 month treatment completion.
Time Frame
one week before treatment, one week post treatment
Title
Trauma Symptoms Inventory (change from baseline at one week post treatment)
Description
100 item trauma symptoms questionnaire to be administered pre-treatment and one week following 4 month treatment completion.
Time Frame
one week before treatment, one week post treatment
Secondary Outcome Measure Information:
Title
Parenting Stress Index for Incarcerated Women (change from baseline at one week post treatment)
Description
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.
Time Frame
one week before treatment, one week post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: An Level of Service Inventory (LSI) score of 30 or greater An LSI protective score of 15 or less 1.5 years or less remaining in prison A Case Plan identifying substance abuse treatment need Ability to read and comprehend 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachael Swopes, M.S.
Organizational Affiliation
University of Tulsa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eddie Warrior Correctional Facility
City
Taft
State/Province
Oklahoma
ZIP/Postal Code
74463
Country
United States

12. IPD Sharing Statement

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Substance Abuse and Trauma in Incarcerated Women

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