Antisocial BehaviorMCTNCT06981351
Matching Treatments to Cognitive Deficits in Offenders With Substance Use Disorders
A study testing Attention to Context (ATC) training in people with Antisocial Behavior, run by The Mind Research Network at 1 site in United States.
Trial summary
The goal of this clinical trial is to investigate the effect of two types of cognitive remediation training on real-world behavioral outcomes including substance use, institutional adjustment, and recidivism following release from prison. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Antisocial Behavior
- What is being tested?
- Attention to Context (ATC) training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2025to 31 May 2029
- 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 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Currently incarcerated
- No uncorrectable auditory or visual deficits
- Able to speak and/or understand English
- 5th grade reading level or higher
- IQ score = 80 or above
- Lifetime history of substance use disorder based on DSM criteria
Show all 10Show fewer
- No history of dementia or other cognitive disability
- No indication of current psychotic disorder
- No major medical illness or CNS disease
- Scores from the Psychopathy Checklist-Revised (PCL-R) meet criteria for one of the designated treatment groups
Who cannot join
- -
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, 1 recruiting
- Recruiting
Mind Research Network/Lovelace Biomedical Research Institute
Albuquerque, New Mexico, 87106
Carla Harenski, 505-272-5028, charenski@mrn.org
About this study
The goal of this clinical trial is to investigate the effect of two types of cognitive remediation training on real-world behavioral outcomes including substance use, institutional adjustment, and recidivism following release from prison. Each training type is designed to target one of two subtypes of antisocial criminal offenders, who are characterized by either: 1) Attention to context-based deficits, or 2) Affective cognitive control-based deficits.
The main questions it aims to answer are:
Read more
Does matching deficit type with targeted cognitive training improve outcomes (relative to mismatched training)? What are the functional brain mechanisms that underlie treatment change?
Participants will:
Be assigned to cognitive training that either does or does not match their deficit type.
Complete six one-hour sessions of cognitive skills training. Complete pre and post-training behavioral tasks assessing self-regulation deficits.
Complete structural MRI scans and functional MRI scans assessing cognitive control.
Complete post-treatment follow-up assessments evaluating self-regulation, adjustment, and stressful life events, substance use and recidivism.
Read the detailed description
Prior research has identified two subtypes of antisocial offenders, typified by distinct dysfunctional cognitive emotion interactions undermining self-regulation. One subtype is characterized by an attention-based abnormality, which impairs adaptive processing of contextual information, tangential to one's primary focus. This abnormality is typified by offenders with high levels of callous/unemotional traits. A second subtype is characterized by hyper-reactions to personally relevant cues, interfering with executive functions that are otherwise needed to regulate behavior. This abnormality is prevalent in those with high externalizing characteristics. The investigators have developed cognitive skills training that addresses each of these specific deficits in distinct ways. These distinct interventions are intended to address mechanism-specific cognitive emotional dysfunction, as opposed to treating distinct dysfunctions with a uniform approach. The investigators' NIH-funded pilot work has shown evidence of improving outcomes in offenders by matching specific deficits with focused skills training. This project will execute a well-powered, randomized clinical trial to demonstrate reliability and generalizability of these effects. We expect to verify prior findings of improved outcomes by matching individual deficits with the targeted interventions. Effects of treatment on specific cognitive skills (assessed by laboratory-based tests) and real-world behavioral outcomes including substance use behaviors, institutional adjustment, and recidivism following release from prison will be examined. Further, advanced neuroimaging measures will be used to assess brain changes with treatment. This will aid in specifying potentially different mechanisms of treatment success in each respective group. This project addresses the ongoing need to improve and validate focused interventions that target specific deficits, replacing less-effective one-size-fits-all approaches.
- Conditions
- Antisocial Behavior
- Being tested
- Attention to Context (ATC) training, Affective Cognitive Control (ACC) training
- Keywords
- Cognitive skills training, Attention to Context, Affective Cognitive Control
- Medical subject headings
- Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention to Context (ATC) trainingBehavioural
ATC training focuses on learning to attend to and integrate contextual cues present in the environment. Three tasks, Reversal Learning, Divided Visual Field, and Affective Gaze, require ATC functioning and provide individuals with practice noticing changes in contextual information, such as rule changes and using emotion information to modulate behavior.
Affective Cognitive Control (ACC) trainingBehavioural
ACC training focuses on providing individuals with practice inhibiting behavior, particularly within motivational or affective contexts. Three tasks, Shapes, Numbers, and Lottery, tap ACC functioning and place demands on the basic employment of cognitive control, such as task switching, as well as on the concurrent engagement of cognitive control and affective processing.
| Study group | Role | What they receive |
|---|---|---|
| Attention to context deficit | Experimental | Participants with attention to context deficits will receive treatment either targeted towards their specific deficit (matched) or towards affective cognitive control deficits (mismatched). Receives: Behavioral: Attention to Context (ATC) training; Behavioral: Affective Cognitive Control (ACC) training |
| Affective Cognitive Control deficit | Experimental | Participants with affective cognitive control deficits will receive treatment either targeted towards their specific deficit (matched) or towards attention to context deficits (mismatched). Receives: Behavioral: Attention to Context (ATC) training; Behavioral: Affective Cognitive Control (ACC) training |
| No psychopathology | Experimental | Participants in the no psychopathology group will receive one of the two treatment types (ATC or ACC). Receives: Behavioral: Attention to Context (ATC) training; Behavioral: Affective Cognitive Control (ACC) training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive task performance - Stroop
Stroop task. Performance is quantified by number of correct responses (0 - 100)%.
Measured: From enrollment to end of treatment at six weeks
Cognitive task performance - Lexical Decision Making
Lexical Decision Making task. Performance is quantified by number of correct responses (0 - 100%).
Measured: From enrollment to end of treatment at six weeks
Cognitive task performance - Delay Discounting
Delay Discounting task. Performance is quantified quantified by calculating where the answers place the respondent amid reference discounting curves. Range 0.0-0.5.
Measured: From enrollment to end of treatment at six weeks
Functional MRI - Go/NoGo task performance
Functional MRI task performance (Go/NoGo task). Performance is quantified by the number of 'false alarms' (responding to the NoGo stimulus). Range 0-39.
Measured: Change assessed from enrollment to end of treatment at six weeks
Functional MRI - Go/Nogo brain response
Change (i.e. increased or decreased) in functional brain response (Blood Oxygen Level Dependent/BOLD) in region of interest (anterior cingulate) assessed using Statistical Parametric Mapping (SPM).
Measured: Activity assessed during MRI scan. Change assessed from enrollment to end of treatment at six weeks
Real-World Outcomes - Substance use (TLFB)
Substance use. Assessed using the timeline follow back (TLFB) - calendar recording dates of use for stimulant drugs.
Measured: From enrollment to six months post-release from incarceration
Real-World Outcomes - Substance use (ASE)
Substance use. Assessed using the Abstinence Self Efficacy scale (higher scores indicate greater difficulty with abstinence). Range 0-4.
Measured: From enrollment to six months post-release from incarceration
Real-World Outcomes - Substance use (DUDIT)
Substance use. Assessed using the Drug Use Disorders Identification test (higher scores indicate more/severe substance use). Range 0-44.
Measured: From enrollment to six months post-release from incarceration
Real-World Outcomes - Criminal behavior
Criminal behavior. Assessed using the Crime Inventory - records the number of instances of criminal behavior
Measured: From enrollment to six months post-release from incarceration
Risky Impulsive Self-Destructive Behavior
The RISQ questionnaire measures risky, impulsive, and self-destructive behaviors in 8 domains (aggression, self-harm, gambling, impulsive spending/driving, impulsive eating, risky sex, illegal behavior, and alcohol use). For each behavior, respondents note the number of times they have engaged in the behavior in their lifetime. Higher scores indicate more severe risky, impulsive, and self destructive behavior.
Measured: From enrollment to six months post-release from incarceration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start18 Mar 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antisocial 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Mind Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981351
- Sponsor's protocol ID
- 24615
- Other IDs
- R01DA058004
- Acronym
- MCT
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matching Treatments to Cognitive Deficits in Offenders With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT06981351
- Acronym / sponsor ID
- MCT / 24615
- Conditions
- Antisocial Behavior
- Keywords
- Cognitive skills training, Attention to Context, Affective Cognitive Control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- The Mind Research NetworkUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 20 May 2025 (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 goal of this clinical trial is to investigate the effect of two types of cognitive remediation training on real-world behavioral outcomes including substance use, institutional adjustment, and recidivism following release from prison. Each training type is designed to target one of two subtypes of antisocial criminal offenders, who are characterized by either: 1) Attention to context-based deficits, or 2) Affective cognitive control-based deficits.
The main questions it aims to answer are:
Does matching deficit type with targeted cognitive training improve outcomes (relative to mismatched training)? What are the functional brain mechanisms that underlie treatment change?
Participants will:
Be assigned to cognitive training that either does or does not match their deficit type.
Complete six one-hour sessions of cognitive skills training. Complete pre and post-training behavioral tasks assessing self-regulation deficits.
Complete structural MRI scans and functional MRI scans assessing cognitive control.
Complete post-treatment follow-up assessments evaluating self-regulation, adjustment, and stressful life events, substance use and recidivism.
Detailed description
Prior research has identified two subtypes of antisocial offenders, typified by distinct dysfunctional cognitive emotion interactions undermining self-regulation. One subtype is characterized by an attention-based abnormality, which impairs adaptive processing of contextual information, tangential to one's primary focus. This abnormality is typified by offenders with high levels of callous/unemotional traits. A second subtype is characterized by hyper-reactions to personally relevant cues, interfering with executive functions that are otherwise needed to regulate behavior. This abnormality is prevalent in those with high externalizing characteristics. The investigators have developed cognitive skills training that addresses each of these specific deficits in distinct ways. These distinct interventions are intended to address mechanism-specific cognitive emotional dysfunction, as opposed to treating distinct dysfunctions with a uniform approach. The investigators' NIH-funded pilot work has shown evidence of improving outcomes in offenders by matching specific deficits with focused skills training. This project will execute a well-powered, randomized clinical trial to demonstrate reliability and generalizability of these effects. We expect to verify prior findings of improved outcomes by matching individual deficits with the targeted interventions. Effects of treatment on specific cognitive skills (assessed by laboratory-based tests) and real-world behavioral outcomes including substance use behaviors, institutional adjustment, and recidivism following release from prison will be examined. Further, advanced neuroimaging measures will be used to assess brain changes with treatment. This will aid in specifying potentially different mechanisms of treatment success in each respective group. This project addresses the ongoing need to improve and validate focused interventions that target specific deficits, replacing less-effective one-size-fits-all approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Attention to context deficit | Experimental | Behavioral: Attention to Context (ATC) training, Behavioral: Affective Cognitive Control (ACC) trainingParticipants with attention to context deficits will receive treatment either targeted towards their specific deficit (matched) or towards affective cognitive control deficits (mismatched). |
| Affective Cognitive Control deficit | Experimental | Behavioral: Attention to Context (ATC) training, Behavioral: Affective Cognitive Control (ACC) trainingParticipants with affective cognitive control deficits will receive treatment either targeted towards their specific deficit (matched) or towards attention to context deficits (mismatched). |
| No psychopathology | Experimental | Behavioral: Attention to Context (ATC) training, Behavioral: Affective Cognitive Control (ACC) trainingParticipants in the no psychopathology group will receive one of the two treatment types (ATC or ACC). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Currently incarcerated
- No uncorrectable auditory or visual deficits
- Able to speak and/or understand English
- 5th grade reading level or higher
- IQ score = 80 or above
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Attention to Context (ATC) trainingATC training focuses on learning to attend to and integrate contextual cues present in the environment. Three tasks, Reversal Learning, Divided Visual Field, and Affective Gaze, require ATC functioning and provide individuals with practice noticing changes in contextual information, such as rule changes and using emotion information to modulate behavior. | Behavioural | Affective Cognitive Control deficit, Attention to context deficit, No psychopathology |
| Affective Cognitive Control (ACC) trainingACC training focuses on providing individuals with practice inhibiting behavior, particularly within motivational or affective contexts. Three tasks, Shapes, Numbers, and Lottery, tap ACC functioning and place demands on the basic employment of cognitive control, such as task switching, as well as on the concurrent engagement of cognitive control and affective processing. | Behavioural | Affective Cognitive Control deficit, Attention to context deficit, No psychopathology |
Primary outcome
Cognitive task performance - Stroop
Time frame: From enrollment to end of treatment at six weeks
Stroop task. Performance is quantified by number of correct responses (0 - 100)%.
Cognitive task performance - Lexical Decision Making
Time frame: From enrollment to end of treatment at six weeks
Lexical Decision Making task. Performance is quantified by number of correct responses (0 - 100%).
Cognitive task performance - Delay Discounting
Time frame: From enrollment to end of treatment at six weeks
Delay Discounting task. Performance is quantified quantified by calculating where the answers place the respondent amid reference discounting curves. Range 0.0-0.5.
Functional MRI - Go/NoGo task performance
Time frame: Change assessed from enrollment to end of treatment at six weeks
Functional MRI task performance (Go/NoGo task). Performance is quantified by the number of 'false alarms' (responding to the NoGo stimulus). Range 0-39.
Functional MRI - Go/Nogo brain response
Time frame: Activity assessed during MRI scan. Change assessed from enrollment to end of treatment at six weeks
Change (i.e. increased or decreased) in functional brain response (Blood Oxygen Level Dependent/BOLD) in region of interest (anterior cingulate) assessed using Statistical Parametric Mapping (SPM).
Real-World Outcomes - Substance use (TLFB)
Time frame: From enrollment to six months post-release from incarceration
Substance use. Assessed using the timeline follow back (TLFB) - calendar recording dates of use for stimulant drugs.
Real-World Outcomes - Substance use (ASE)
Time frame: From enrollment to six months post-release from incarceration
Substance use. Assessed using the Abstinence Self Efficacy scale (higher scores indicate greater difficulty with abstinence). Range 0-4.
Real-World Outcomes - Substance use (DUDIT)
Time frame: From enrollment to six months post-release from incarceration
Substance use. Assessed using the Drug Use Disorders Identification test (higher scores indicate more/severe substance use). Range 0-44.
Real-World Outcomes - Criminal behavior
Time frame: From enrollment to six months post-release from incarceration
Criminal behavior. Assessed using the Crime Inventory - records the number of instances of criminal behavior
Risky Impulsive Self-Destructive Behavior
Time frame: From enrollment to six months post-release from incarceration
The RISQ questionnaire measures risky, impulsive, and self-destructive behaviors in 8 domains (aggression, self-harm, gambling, impulsive spending/driving, impulsive eating, risky sex, illegal behavior, and alcohol use). For each behavior, respondents note the number of times they have engaged in the behavior in their lifetime. Higher scores indicate more severe risky, impulsive, and self destructive behavior.
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 17 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention to Context (ATC) training in people with Antisocial Behavior, run by The Mind Research Network 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 10 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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?
Contact Carla Harenski (505-272-5028, charenski@mrn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive task performance - Stroop (time frame: From enrollment to end of treatment at six weeks). The study lists 10 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 17 Aug 2026.