Matching Treatments to Cognitive Deficits in Offenders With Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- Cognitive task performance - Stroop
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Staff that conduct cognitive skills training sessions will be blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- 未提供
研究组 & 干预措施
No psychopathology
Participants in the no psychopathology group will receive one of the two treatment types (ATC or ACC).
干预措施: Affective Cognitive Control (ACC) training (Behavioral)
Attention to context deficit
Participants with attention to context deficits will receive treatment either targeted towards their specific deficit (matched) or towards affective cognitive control deficits (mismatched).
干预措施: Attention to Context (ATC) training (Behavioral)
Affective Cognitive Control deficit
Participants with affective cognitive control deficits will receive treatment either targeted towards their specific deficit (matched) or towards attention to context deficits (mismatched).
干预措施: Attention to Context (ATC) training (Behavioral)
Affective Cognitive Control deficit
Participants with affective cognitive control deficits will receive treatment either targeted towards their specific deficit (matched) or towards attention to context deficits (mismatched).
干预措施: Affective Cognitive Control (ACC) training (Behavioral)
No psychopathology
Participants in the no psychopathology group will receive one of the two treatment types (ATC or ACC).
干预措施: Attention to Context (ATC) training (Behavioral)
Attention to context deficit
Participants with attention to context deficits will receive treatment either targeted towards their specific deficit (matched) or towards affective cognitive control deficits (mismatched).
干预措施: Affective Cognitive Control (ACC) training (Behavioral)
结局指标
主要结局
Cognitive task performance - Stroop
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点