- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01413984
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
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Taft, Oklahoma, United States, 74463
- Eddie Warrior Correctional Facility
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
Experimental: cognitive behavioral group treatment
Helping Women Recover/Beyond Trauma integrated substance abuse and trauma treatment group.
(Dr.
Covington)
|
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
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
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
Sponsor
Investigators
- Principal Investigator: Rachael Swopes, M.S., University of Tulsa
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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