Substance Abuse and Trauma in Incarcerated Women

Trauma Clinical Trial

Official title:

Substance Abuse and Trauma in Incarcerated Women: An Effectiveness Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413984
• Other study ID #: TU 11-18
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: March 17, 2014
• Start date: November 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2014
• Source: University of Tulsa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Oklahoma Department of CorrectionsUnited States: TU IRBUnited States: TU Psychology Department
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Incarcerated Women
• Integrated Treatment
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Abuse
• Substance-Related Disorders
• Trauma
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Eddie Warrior Correctional Facility	Taft	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Tulsa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one-week before treatment, one week post treatment	No
Primary	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.	one week before treatment, one week post treatment	No
Primary	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.	one week before treatment, one week post treatment	No
Primary	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.	one week before treatment, one week post treatment	No
Primary	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.	one week before treatment, one week post treatment	No
Primary	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.	one week before treatment, one week post treatment	No
Secondary	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.	one week before treatment, one week post treatment	No