Clinical trial NCT00249561: Colorado Women's TC Project
Official title: Women's Prison TC: Outcomes, Process & Economic Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Substance-Related Disorders
Lead sponsor: National Development and Research Institutes, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-11-07
Enrollment: 610
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The major aim of the project is to document and evaluate two treatments for female offenders with substance abuse problems (TC and cognitive behavioral), simultaneously studying the process of treatment, and relating treatment process to treatment outcome.

Detailed description: The number and proportion of substance abusing women in prison have been increasing, creating a need for programs tailored to this population, and for evaluation of such programs. The specific aims of this project were: (1) to conduct a rigorous evaluation of the effectiveness of prison TC treatment for substance abusing women offenders; (2) to investigate the treatment process for the target population and to explore the relationship between the process and outcome of treatment; (3) to evaluate the cost and cost effectiveness of treatment; and (4) to assess issues in obtaining and making use of aftercare services and provide information regarding the additional contribution of aftercare treatment. The core investigation, over four years (n=600), randomly assigned female substance abusing offenders at the Denver Women's Correctional Facility to either a TC program, Recovery By Choice, the experimental (E) condition (n=300), or to a non-TC standard program, the comparison (C) condition (n=300). The study predicted better outcomes for the TC group in an intent-to-treat analysis of all study entrants. The Aim 4 supplementary study of aftercare, with no random assignment, followed program completers from E and C as they entered mandatory aftercare, choosing either TC aftercare or a non-TC treatment alternative. The research employed a prospective, longitudinal, repeated measures assessment with five points (baseline, 6-, 12-, and 18-months post-baseline) to assess standard outcome measures (e.g., drug use, crime, and employment), as well as specific measures of particular concern to female offenders (e.g., trauma and abuse). In addition to self-report data, urine toxicology and criminal record data were obtained. The study collected process data, guided by the Texas Christian University Treatment Process Model, The project contributes to a theoretical advance in our understanding of the process of treatment for women offenders in prison TCs. It advances research through a rigorous study of TC prison program effectiveness for women compared to another, routine treatment. It guides practice by delineating treatment elements for women and by examining the effectiveness of a TC program that organizes these elements. Finally, it integrates outcome and economic analysis to inform policy and planning about the effectiveness of the TC treatment under study. Perhaps most significantly, it tests TC principles and methods found effective for substance-abusing male offenders, which have been adapted for women, thereby increasing the potential utility of these strategies.

Eligibility criteria: Inclusion criteria:

* at least 6 months, and no more than 24 months, remaining until parole eligibility;
* a CDOC "Standardized Offender Assessment" (SOA; CDOC, 2004) score indicative of serious substance abuse problems mandating substance abuse treatment; and
* a security risk level classification of minimum, minimum-restricted, or medium (necessary to permit participation in treatment).

Exclusion criteria:

* less than 6 months, or more than 24 months, remaining until parole eligibility;
* a CDOC "Standardized Offender Assessment" (SOA; CDOC, 2004) score that is not indicative of serious substance abuse problems mandating substance abuse treatment; or
* a security risk level classification above medium.

Primary outcomes:
measure: Intake CTCR Baseline & Follow-Up Protocol (CTCR Protocol)
timeFrame: At entry
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: At entry
measure: Rosenberg Self-Esteem (SES)
timeFrame: At entry
measure: Symptom CheckList 90-R (SCL90-R)
timeFrame: At entry
measure: Diagnostic Interview Survey (DIS-IV)
timeFrame: At entry
measure: Parenting Practices Scale (PPS)
timeFrame: At entry
measure: Social Support Arizona Social Support Scale (ASSIS)
timeFrame: At entry
measure: Texas Christian University Resident Evaluation of Self and Treatment (TCU-REST)
measure: Client Assessment Inventory (CAI)
measure: Circumstances, Motivation and Readiness (CMR)
measure: Cost: Drug Abuse Treatment Cost Analysis Program (DATCAP)
measure: Service Utilization Form (SUF)
measure: Partner Abuse Scales (PAS)
Secondary outcomes:
measure: Colorado Department of Corrections Record Information System (CDOC-RIS)
measure: Biological Specimens
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Women's Correctional Facility
state: Colorado
Study officials:
affiliation: National Development and Research Institutes, Inc.
name: JoAnn Y Sacks, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sacks JY, McKendrick K, Hamilton Z, Cleland CM, Pearson FS, Banks S. Treatment outcomes for female offenders: relationship to number of Axis I diagnoses. Behav Sci Law. 2008;26(4):413-34. doi: 10.1002/bsl.828.