Computer-assisted, Evidence-based Psychosocial InterventionCPTNCT01277939
CPT for Offenders With SUD
A study testing Therapeutic Education System (TES) in people with Computer-assisted, Evidence-based Psychosocial Intervention and for Substance Abuse Treatment, run by National Development and Research Institutes, Inc. at 10 sites in United States.
Trial summary
This study will evaluate the comparative effectiveness of Therapeutic Education System (TES), a computer-based, psychosocial treatment program, relative to standard care when offered to individuals with substance use disorders in prison settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Computer-assisted, Evidence-based Psychosocial Intervention, for Substance Abuse Treatment
- What is being tested?
- Therapeutic Education System (TES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individual's parole eligibility date or mandatory release date must be scheduled to occur within a minimum of 4 months (to allow intake an treatment to be completed) and a maximum of 6 months (to ensure that their release follows completion of their treatment such that sufficient time remains for post-prison follow-up interviews to occur within the two-year project timeframe)
- the state criminal justice system must have identified the individual to have a substance use disorder that requires a substance abuse intervention
- the individual must give their informed consent
Who cannot join
- the individual must not already be participating in substance abuse treatment
- the individual must speak English, as TES is now only available in English
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Airway Heights Corrections Center
Airway Heights, Washington, 99001
SCI Cambridge Springs
Cambridge Springs, Pennsylvania, 16403
Colorado Territorial Correctional Facility
Cañon City, Colorado, 81215
Four Mile Correctional Center
Cañon City, Colorado, 81215
Fremont Correctional Facility
Cañon City, Colorado, 81215
Denver Women's Correctional Facility
Denver, Colorado, 80239
Blackburn Correctional Complex
Lexington, Kentucky, 40511
Trinidad Correctional Facility
Model, Colorado, 81509
La Vista Correctional Facility
Pueblo, Colorado, 81002
Sterling Correctional Facility
Sterling, Colorado, 80751
About this study
Official title: Computerized Psychosocial Treatment for Offenders With Substance Use Disorders
This study will evaluate the comparative effectiveness of Therapeutic Education System (TES), a computer-based, psychosocial treatment program, relative to standard care when offered to individuals with substance use disorders in prison settings. The study will assess the comparative effectiveness of these interventions primarily by examining changes in: (1) substance use (e.g., weeks of abstinence), (2) HIV risk behavior (evaluated as both sex-related and drug-related HIV risk behavior) and (3) reincarceration rates. The study will also examine the extent to which these interventions improve psychosocial functioning (e.g., employment, health, and psychological status) and quality of life, and promote relevant skills acquisition (e.g., improve communication skills, reduce "criminal thinking"). The investigators predict significantly better outcomes for E vs. C due to TES' research-based content and use of proven informational technologies.
Read the detailed description
The majority of individuals in criminal justice settings across the U.S. have a critical need for science-based, psychosocial treatment that targets substance use and HIV risk behavior. The investigative team has developed and demonstrated the efficacy of an interactive, computer-based, psychosocial treatment pro-gram, the Therapeutic Education System (TES), which can answer this need. TES is theoretically grounded in evidence-based psychosocial treatments (Community Reinforcement Approach and Cognitive Behavioral Therapy), and employs state-of-the-art, proven informational technologies and multimedia learning tools to promote skills acquisition, experiential learning and behavioral change. This computer-based therapeutic tool allows complex interventions to be delivered with fidelity to the evidence-based model and at low cost due to its self-directed nature (e.g., minimal staff time/training needed), thus offering considerable potential for future sustainability and dissemination within criminal justice systems.
The study employs random assignment of incarcerated male and female offenders with substance use disorders (N=526) to either (1) TES (N=263), or (2) Standard Care (N=263), in a multi-site trial conducted in 8 prison substance abuse programs. Along with NDRI (the applicant organization), the collaborating study sites (University of California Los Angeles, Temple University, and the University of Kentucky) operate Research Centers that belong to the Criminal Justice Drug Abuse Treatment Studies (CJDATS) network, a NIDA-funded cooperative agreement, which has established relationships with criminal justice partners from Departments of Corrections across the U.S. Aim 1 is to test the comparative effectiveness of TES vs. Standard Care on measures of drug use (e.g., weeks of abstinence) and HIV risk behavior (both sex-related and drug-related HIV risk behavior) at 3- and 6-months post prison discharge, as well as on reincarceration rates using official Department of Corrections records. Aim 2 is to evaluate the cost and cost-effectiveness of TES relative to standard care. The investigators predict that TES will be significantly more effective and cost effective than Standard Care.
The project is significant in its use of an innovative, computer-based technology and in its potential to produce a major increase in the effective and cost-effective delivery of science-based psychosocial treatment to substance-abusing offenders in prison, and thereby make a considerable public health contribution. Thus, funding the proposed 2-year project can markedly accelerate the pace and achievement of research and dissemination efforts to meet the needs of the U.S. correctional community by providing effective and practical treatment interventions for its large substance-abusing population.
- Conditions
- Computer-assisted, Evidence-based Psychosocial Intervention, for Substance Abuse Treatment
- Being tested
- Therapeutic Education System (TES), Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Education System (TES)Behavioural
Therapeutic Education System (TES) is an interactive, computer-based, psychosocial treatment program. TES is theoretically grounded in evidence-based psychosocial treatments (Community Reinforcement Approach and Cognitive Behavioral Therapy).
Standard CareBehavioural
Psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Education System (TES) | Experimental | Experimental (E) condition, the Therapeutic Education System (TES) delivered via effective informational technologies and multimedia learning tools. Receives: Behavioral: Therapeutic Education System (TES) |
| Standard Care | Active comparator | The Control (C) condition, Standard Care, consisting of psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)
Measure for substance use.
Measured: 6 months post-prison release
Urinalysis
To detect any change in illicit drug use.
Measured: 6 months post-prison release
Risk Behavior Survey (Booth et al., 1993)
To assess both drug-related and sex-related HIV risk behavior.
Measured: 6 months post-prison release
DOC record systems
To provide the reincarceration status of each participant.
Measured: At an average of 11 months post-prison release
Secondary outcomes (5)
Coping Strategies Scale
Measures skills acquisition, such as problem solving and dealing with urges to use substances of abuse (Litt et al., 2005), and psychosocial functioning
Measured: 6 months post-prison release
Addiction Severity Index-Lite
Measures areas of health status improvement, psychological status, family/social relationships, and employment. (www.tresearch.org)
Measured: 6 months post-prison release
The Treatment Services Review instrument (McLellan et al., www.tresearch.org)
Used to investigate the role of treatment services received post-release (in aftercare).
Measured: 6 months post-prison release
Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)
Measures for the cost effectiveness analyses.
Measured: 6 months post-prison release
EuroQol EQ5D (QOL) (the EuroQol Group, 1990)
Describes and value health-related quality of life and for constructing Quality-Adjusted Life Year estimates (QALYs).
Measured: 6 months post-prison release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startSep 2009
- Primary completionAug 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computer-assisted, Evidence-based Psychosocial InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Temple University, University of Kentucky, University of Miami, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Stan Sacks, PhD, Principal investigator, National Development & Research Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277939
- Sponsor's protocol ID
- NDRI-612
- Other IDs
- 1RC2DA028967
- Acronym
- CPT
- Status last verified
- Aug 2013
- First submitted
- 12 Jan 2011
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Psychosocial Treatment for Offenders With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT01277939
- Acronym / sponsor ID
- CPT / NDRI-612
- Conditions
- Computer-assisted, Evidence-based Psychosocial Intervention, for Substance Abuse Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- University of California, Los Angeles, Temple University, University of Kentucky, University of Miami, National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the comparative effectiveness of Therapeutic Education System (TES), a computer-based, psychosocial treatment program, relative to standard care when offered to individuals with substance use disorders in prison settings. The study will assess the comparative effectiveness of these interventions primarily by examining changes in: (1) substance use (e.g., weeks of abstinence), (2) HIV risk behavior (evaluated as both sex-related and drug-related HIV risk behavior) and (3) reincarceration rates. The study will also examine the extent to which these interventions improve psychosocial functioning (e.g., employment, health, and psychological status) and quality of life, and promote relevant skills acquisition (e.g., improve communication skills, reduce "criminal thinking"). The investigators predict significantly better outcomes for E vs. C due to TES' research-based content and use of proven informational technologies.
Detailed description
The majority of individuals in criminal justice settings across the U.S. have a critical need for science-based, psychosocial treatment that targets substance use and HIV risk behavior. The investigative team has developed and demonstrated the efficacy of an interactive, computer-based, psychosocial treatment pro-gram, the Therapeutic Education System (TES), which can answer this need. TES is theoretically grounded in evidence-based psychosocial treatments (Community Reinforcement Approach and Cognitive Behavioral Therapy), and employs state-of-the-art, proven informational technologies and multimedia learning tools to promote skills acquisition, experiential learning and behavioral change. This computer-based therapeutic tool allows complex interventions to be delivered with fidelity to the evidence-based model and at low cost due to its self-directed nature (e.g., minimal staff time/training needed), thus offering considerable potential for future sustainability and dissemination within criminal justice systems.
The study employs random assignment of incarcerated male and female offenders with substance use disorders (N=526) to either (1) TES (N=263), or (2) Standard Care (N=263), in a multi-site trial conducted in 8 prison substance abuse programs. Along with NDRI (the applicant organization), the collaborating study sites (University of California Los Angeles, Temple University, and the University of Kentucky) operate Research Centers that belong to the Criminal Justice Drug Abuse Treatment Studies (CJDATS) network, a NIDA-funded cooperative agreement, which has established relationships with criminal justice partners from Departments of Corrections across the U.S. Aim 1 is to test the comparative effectiveness of TES vs. Standard Care on measures of drug use (e.g., weeks of abstinence) and HIV risk behavior (both sex-related and drug-related HIV risk behavior) at 3- and 6-months post prison discharge, as well as on reincarceration rates using official Department of Corrections records. Aim 2 is to evaluate the cost and cost-effectiveness of TES relative to standard care. The investigators predict that TES will be significantly more effective and cost effective than Standard Care.
The project is significant in its use of an innovative, computer-based technology and in its potential to produce a major increase in the effective and cost-effective delivery of science-based psychosocial treatment to substance-abusing offenders in prison, and thereby make a considerable public health contribution. Thus, funding the proposed 2-year project can markedly accelerate the pace and achievement of research and dissemination efforts to meet the needs of the U.S. correctional community by providing effective and practical treatment interventions for its large substance-abusing population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Education System (TES) | Experimental | Behavioral: Therapeutic Education System (TES)Experimental (E) condition, the Therapeutic Education System (TES) delivered via effective informational technologies and multimedia learning tools. |
| Standard Care | Active comparator | Behavioral: Standard CareThe Control (C) condition, Standard Care, consisting of psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- individual's parole eligibility date or mandatory release date must be scheduled to occur within a minimum of 4 months (to allow intake an treatment to be completed) and a maximum of 6 months (to ensure that their release follows completion of their treatment such that sufficient time remains for post-prison follow-up interviews to occur within the two-year project timeframe)
- the state criminal justice system must have identified the individual to have a substance use disorder that requires a substance abuse intervention
- the individual must give their informed consent
Key exclusion criteria (2 listed)
- the individual must not already be participating in substance abuse treatment
- the individual must speak English, as TES is now only available in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Education System (TES)Therapeutic Education System (TES) is an interactive, computer-based, psychosocial treatment program. TES is theoretically grounded in evidence-based psychosocial treatments (Community Reinforcement Approach and Cognitive Behavioral Therapy). | Behavioural | Therapeutic Education System (TES) |
| Standard CarePsycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats. | Behavioural | Standard Care |
Primary outcome
Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)
Time frame: 6 months post-prison release
Measure for substance use.
Urinalysis
Time frame: 6 months post-prison release
To detect any change in illicit drug use.
Risk Behavior Survey (Booth et al., 1993)
Time frame: 6 months post-prison release
To assess both drug-related and sex-related HIV risk behavior.
DOC record systems
Time frame: At an average of 11 months post-prison release
To provide the reincarceration status of each participant.
5 secondary outcomes
Coping Strategies Scale
Time frame: 6 months post-prison release
Addiction Severity Index-Lite
Time frame: 6 months post-prison release
The Treatment Services Review instrument (McLellan et al., www.tresearch.org)
Time frame: 6 months post-prison release
Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)
Time frame: 6 months post-prison release
EuroQol EQ5D (QOL) (the EuroQol Group, 1990)
Time frame: 6 months post-prison release
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stan Sacks, PhD principal investigator
National Development & Research Institutes
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Education System (TES) in people with Computer-assisted, Evidence-based Psychosocial Intervention and for Substance Abuse Treatment, run by National Development and Research Institutes, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996) (time frame: 6 months post-prison release). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2013.