Criminal BehaviorNCT05109689
A Randomized Controlled Trial of ACT-P Versus T4C for Community Reentry
A study testing ACT-P and T4C in people with Criminal Behavior and Violence, run by Iowa State University at 1 site in United States.
Trial summary
The purpose of the proposed study is to determine the efficacy of Acceptance and Commitment Therapy for prisons (ACT-P) and Thinking for a Change (T4C) as reentry programs in a randomized controlled trial (RCT). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Criminal Behavior, Violence
- What is being tested?
- ACT-P and T4C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- deemed medium or high risk according to the Iowa Risk Revised
- eligible and appropriate for cognitive programming as determined by normal operating procedures
Who cannot join
- court-mandated to either program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fort Dodge Correctional Facility
Fort Dodge, Iowa, 50501
About this study
Official title: A Randomized Controlled Trial of ACT-P Versus T4C for Community Reentry: Differential Efficacy and Mechanisms of Change
The purpose of the proposed study is to determine the efficacy of Acceptance and Commitment Therapy for prisons (ACT-P) and Thinking for a Change (T4C) as reentry programs in a randomized controlled trial (RCT).
Read the detailed description
The proposed study will focus on medium to high risk adult males, currently institutionalized and approaching release, who will be randomized to Acceptance and Commitment Therapy for prisons (ACT-P) or the Thinking for a Change (T4C) program. ACT-P is a cognitive behavioral treatment that targets acceptance and mindfulness processes to reduce criminal behavior, and has been adapted for the prison setting. T4C is a widely used and well-established traditional cognitive behavioral program that targets changing criminal thinking.
The first aim of the study is to test the relative efficacy of the ACT-P intervention, compared to T4C, on recidivism. Recidivism will be measured in 3 ways: rearrests, reconvictions, and reincarceration during the 3 years post-release. A secondary aim is to test the theory of change and the proposed mechanisms of ACT-P and T4C. By focusing on the mechanisms that account for program success, it will provide insight into the theory of change underlying each program. Based on the theories underlying each treatment, we hypothesize differences in mechanisms of action between the two treatments. Given the emphasis in T4C on cognitive change, we predict stronger mediation effects in T4C for reductions in antisocial/criminal thinking. In contrast, we hypothesize that increases in psychological flexibility would be stronger mediators for ACT-P than for T4C.
- Conditions
- Criminal Behavior, Violence
- Being tested
- ACT-P, T4C
- Keywords
- Cognitive behavior therapy, Community reentry, Recidivism
- Medical subject headings
- Criminal Behavior, Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-PBehavioural
ACT-P consists of five modules. The Big Picture sessions are interwoven throughout the 24 sessions to introduce the main concepts of the curriculum, such as values identification and awareness of criminal behaviors. The Emotion Regulation and Cognitive Skills modules focus on awareness of internal experiences; learning new ways to respond to internal experiences; identifying and stepping back from problematic/criminal thoughts and beliefs; awareness of behaviors in service of values versus behaviors in service of control/avoidance; and identifying steps for behavior change. The Behavioral Skills module focuses on practicing prosocial behaviors, such as speaking and listening effectively and conflict resolution. Finally, the Barriers to Change module addresses environmental or life circumstances that can hinder successful behavior change (e.g., toxic masculinity, substance use, and parenting difficulties).
T4CBehavioural
Also called Thinking for a Change
T4C is an integrated cognitive behavioral change program authored by Drs. Jack Bush, Barry Glick, and Juliana Taymans under a cooperative agreement with the National Institute of Corrections (NIC). The program is based on the principle that thinking controls how people act, and that to change the way people act, they have to control their thinking. T4C systematically presents the concept that thoughts cause one's behavior, and offenders learn to identify their own thought patterns that lead to risky behavior, and then to replace those maladaptive thoughts with new ones. T4C incorporates research from cognitive restructuring theory, social skills development, and the learning and use of problem solving skills.
| Study group | Role | What they receive |
|---|---|---|
| ACT-P | Experimental | ACT-P is a cognitive behavioral program based on acceptance and commitment therapy, and it has been modified for use in the prison setting. Receives: Behavioral: ACT-P |
| T4C | Active comparator | Thinking for Change (T4C) is an evidence-based cognitive behavioral program focused on changing criminal thinking. Receives: Behavioral: T4C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rearrests, convictions, and reincarcerations
Criminal activity
Measured: 3 years post-release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start21 Feb 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Criminal BehaviorStudies 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
- Model description
- Participants will be randomized into either ACT-P or T4C, two group programs that will run simultaneously.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amie Zarling, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109689
- Sponsor's protocol ID
- 19-569-00
- Status last verified
- Dec 2024
- First submitted
- 27 Oct 2021
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are undecided right now.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of ACT-P Versus T4C for Community Reentry: Differential Efficacy and Mechanisms of Change
- ClinicalTrials.gov ID
- NCT05109689
- Acronym / sponsor ID
- 19-569-00
- Conditions
- Criminal Behavior, Violence
- Keywords
- Cognitive behavior therapy, Community reentry, Recidivism
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Nov 2021 (actual)
- 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.
The purpose of the proposed study is to determine the efficacy of Acceptance and Commitment Therapy for prisons (ACT-P) and Thinking for a Change (T4C) as reentry programs in a randomized controlled trial (RCT).
Detailed description
The proposed study will focus on medium to high risk adult males, currently institutionalized and approaching release, who will be randomized to Acceptance and Commitment Therapy for prisons (ACT-P) or the Thinking for a Change (T4C) program. ACT-P is a cognitive behavioral treatment that targets acceptance and mindfulness processes to reduce criminal behavior, and has been adapted for the prison setting. T4C is a widely used and well-established traditional cognitive behavioral program that targets changing criminal thinking.
The first aim of the study is to test the relative efficacy of the ACT-P intervention, compared to T4C, on recidivism. Recidivism will be measured in 3 ways: rearrests, reconvictions, and reincarceration during the 3 years post-release. A secondary aim is to test the theory of change and the proposed mechanisms of ACT-P and T4C. By focusing on the mechanisms that account for program success, it will provide insight into the theory of change underlying each program. Based on the theories underlying each treatment, we hypothesize differences in mechanisms of action between the two treatments. Given the emphasis in T4C on cognitive change, we predict stronger mediation effects in T4C for reductions in antisocial/criminal thinking. In contrast, we hypothesize that increases in psychological flexibility would be stronger mediators for ACT-P than for T4C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into either ACT-P or T4C, two group programs that will run simultaneously.
| Arm | Type | Receives |
|---|---|---|
| ACT-P | Experimental | Behavioral: ACT-PACT-P is a cognitive behavioral program based on acceptance and commitment therapy, and it has been modified for use in the prison setting. |
| T4C | Active comparator | Behavioral: T4CThinking for Change (T4C) is an evidence-based cognitive behavioral program focused on changing criminal thinking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- deemed medium or high risk according to the Iowa Risk Revised
- eligible and appropriate for cognitive programming as determined by normal operating procedures
Key exclusion criteria (1 listed)
- court-mandated to either program
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 |
|---|---|---|
| ACT-PACT-P consists of five modules. The Big Picture sessions are interwoven throughout the 24 sessions to introduce the main concepts of the curriculum, such as values identification and awareness of criminal behaviors. The Emotion Regulation and Cognitive Skills modules focus on awareness of internal experiences; learning new ways to respond to internal experiences; identifying and stepping back from problematic/criminal thoughts and beliefs; awareness of behaviors in service of values versus behaviors in service of control/avoidance; and identifying steps for behavior change. The Behavioral Skills module focuses on practicing prosocial behaviors, such as speaking and listening effectively and conflict resolution. Finally, the Barriers to Change module addresses environmental or life circumstances that can hinder successful behavior change (e.g., toxic masculinity, substance use, and parenting difficulties). | Behavioural | ACT-P |
| T4CAlso: Thinking for a ChangeT4C is an integrated cognitive behavioral change program authored by Drs. Jack Bush, Barry Glick, and Juliana Taymans under a cooperative agreement with the National Institute of Corrections (NIC). The program is based on the principle that thinking controls how people act, and that to change the way people act, they have to control their thinking. T4C systematically presents the concept that thoughts cause one's behavior, and offenders learn to identify their own thought patterns that lead to risky behavior, and then to replace those maladaptive thoughts with new ones. T4C incorporates research from cognitive restructuring theory, social skills development, and the learning and use of problem solving skills. | Behavioural | T4C |
Primary outcome
Rearrests, convictions, and reincarcerations
Time frame: 3 years post-release
Criminal activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: Undecided. The investigators are undecided right now.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-P and T4C in people with Criminal Behavior and Violence, run by Iowa State University at 1 site 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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Rearrests, convictions, and reincarcerations (time frame: 3 years post-release). 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 30 Dec 2024.