Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Substance Abuse and Trauma in Incarcerated Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rachael Swopes, University of Tulsa
ClinicalTrials.gov Identifier:
NCT01413984
First received: August 3, 2011
Last updated: March 17, 2014
Last verified: March 2014

August 3, 2011
March 17, 2014
November 2010
March 2012   (final data collection date for primary outcome measure)
  • PTSD checklist (change from baseline at one week post treatment) [ Time Frame: one-week before treatment, one week post treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: one week before treatment, one week post treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: one week before treatment, one week post treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: one week before treatment, one week post treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: one week before treatment, one week post treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: one week before treatment, one week post treatment ] [ Designated as safety issue: No ]
    100 item trauma symptoms questionnaire to be administered pre-treatment and one week following 4 month treatment completion.
Same as current
Complete list of historical versions of study NCT01413984 on ClinicalTrials.gov Archive Site
Parenting Stress Index for Incarcerated Women (change from baseline at one week post treatment) [ Time Frame: one week before treatment, one week post treatment ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Substance Abuse and Trauma in Incarcerated Women
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Substance Abuse
  • Trauma
  • Post Traumatic Stress Disorder
  • Integrated Treatment
  • Incarcerated Women
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.
  • Experimental: cognitive behavioral group treatment
    Helping Women Recover/Beyond Trauma integrated substance abuse and trauma treatment group. (Dr. Covington)
    Intervention: Behavioral: Helping Women Recover/Beyond Trauma
  • No Intervention: comparison group
    a comparison group of incarcerated women will receive the pre and post assessments with no interventions.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01413984
TU 11-18
Yes
Rachael Swopes, University of Tulsa
University of Tulsa
Not Provided
Principal Investigator: Rachael Swopes, M.S. University of Tulsa
University of Tulsa
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP