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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH111855 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Interventions that address criminogenic risk factors, such as Thinking for a Change (T4C), are not used with prisoners with serious mental illness (SMI) because of the neurocognitive and social impairments associated with SMI. This study examines the effectiveness of T4C with a modified delivery system designed specifically to address the unique needs of persons with SMI in prison, including improving impulsivity, criminal attitudes, and interpersonal problem solving (treatment targets) and levels of aggression, and the amount of behavioral infractions and time spent in administrative segregation in prison (outcomes).
Interventions are urgently needed to improve the delivery and impact of mental health services for persons with serious mental illnesses (SMI) in prison. Treatments addressing the symptoms of mental illness form a critical component of the continuum of services needed by prisoners with SMI. However, a growing body of literature shows that mental health treatments need to be combined with treatments that directly address criminogenic risk factors (i.e., those factors most closely associated with criminal activities). Despite promising evidence, interventions that address criminogenic risk factors, such as Thinking for a Change (T4C), are not used with prisoners with SMI because of the neurocognitive and social impairments associated with SMI. This study examines the effectiveness of T4C with a modified delivery system designed specifically to address the unique needs of persons with SMI in prison. This small-scale randomized controlled trail (RCT) explores the potential effectiveness of T4C-SMI towards improving impulsivity, criminal attitudes, and interpersonal problem solving (treatment targets) and levels of aggression, and the amount of behavioral infractions and time spent in administrative segregation in prison (outcomes). The study will also examine whether the treatment targets for T4C-SMI mediate the intervention's impact on outcomes.
The long-term goal is to grow the evidence-base for interventions with the capacity to improve prison and community-reentry outcomes for persons with SMI. This study will provide the data needed to implement a rigorous RCT in a future study and supports NIMH's mission to develop innovative interventions in mental health services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T4C-SMI Group | Experimental | Participants will receive the T4C-SMI intervention, in addition to standard prison mental health services |
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| Control Group | No Intervention | The control group receives standard prison mental health services |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T4C-SMI | Behavioral | T4C-SMI entails a 25-session, manualized intervention that is delivered in a closed-group format at least twice a week over a three-month period. The intervention curriculum includes three modules: nine sessions on social skills training, five sessions on cognitive restructuring activities, and ten sessions on problem-solving methods. Participants assigned to T4C-SMI receive this intervention in addition to any other prison mental health services that they are otherwise eligible to receive during their incarceration. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Levels of Aggression Score From Baseline to Month 3 | Aggression Questionnaire - Short Form is a 12-item measure with four subscales: physical aggression, verbal aggression, anger, and hostility. Items are scored on a 6-point Likert scale. Scores range from 12 to 72. The higher the score the more aggression present. | Baseline, Month 3 |
| Change in Levels of Aggression Score From Baseline to Month 6 | Aggression Questionnaire - Short Form is a 12-item measure with four subscales: physical aggression, verbal aggression, anger, and hostility. Items are scored on a 6-point Likert scale. Scores range from 12 to 72. The higher the score the more aggression present. | Baseline, Month 6 |
| Number of Participants With Post Test Behavioral Infractions | Number of participants who have at least 1 behavioral infraction following the intervention. Prison records used to ascertain the number of participants who receive behavioral infractions. | End of intervention through Month 9, approximately 6 months total |
| Median Number of Days in Administrative Segregation | Prison records will be used to determine the total number of days participants are placed in administrative segregation. | End of intervention through Month 9, approximately 6 months total |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overall Interpersonal Problem Solving Score | The Social Problem Solving Inventory - Revised, Long (SPSI-R:L) is a 52-item measure of problem solving skills and problem orientation. Items are measured on a 5-point Likert scale. It has three subscales: problem orientation, problem solving skills, and social problem-solving inventory. The total raw score range is from 0 to 20. Higher score mean more positive social problem solving skills. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy B Wilson, PhD | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina Department of Public Safety | Raleigh | North Carolina | 27699 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bryant FB, Smith BD. Aggression Questionnaire--Short Form. Psyctests. 2001. doi:10.1037/t09754-000 | ||
| Background | D'Zurilla TJ, Nezu AM, Maydeu-Olivares A (n.d). Social Problem-Solving Inventory - Revised. Psyctests. doi:10.1037/t05068-000 | ||
| 12216781 | Background | Mills JF, Kroner DG, Forth AE. Measures of Criminal Attitudes and Associates (MCAA): development, factor structure, reliability, and validity. Assessment. 2002 Sep;9(3):240-53. doi: 10.1177/1073191102009003003. | |
| 8778124 |
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| ID | Title | Description |
|---|---|---|
| FG000 | T4C-SMI Group | The research intervention is Thinking for Change for prisoners with mental illness (T4C-MI). This intervention has two components. The first component is Thinking for a Change (T4C), a CBT based group intervention that includes three treatment modules delivered over the course of 25-sessions in a closed-group format to 8-12 people up to twice a week over 12-14 weeks. The second component of T4C-MI is the Targeted Service Delivery Approach (TSDA) that this research team developed for use during the delivery of T4C to compensate for the impact of the neurocognitive and social impairments associated with mental illness on participants' ability to fully engage in and understand T4C's intervention materials. |
| FG001 | Control Group | The control group receives standard prison treatment and programming |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | T4C-SMI Group | The research intervention is Thinking for Change for prisoners with mental illness (T4C-MI). This intervention has two components. The first component is Thinking for a Change (T4C), a CBT based group intervention that includes three treatment modules delivered over the course of 25-sessions in a closed-group format to 8-12 people up to twice a week over 12-14 weeks. The second component of T4C-MI is the Targeted Service Delivery Approach (TSDA) that this research team developed for use during the delivery of T4C to compensate for the impact of the neurocognitive and social impairments associated with mental illness on participants' ability to fully engage in and understand T4C's intervention materials. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Levels of Aggression Score From Baseline to Month 3 | Aggression Questionnaire - Short Form is a 12-item measure with four subscales: physical aggression, verbal aggression, anger, and hostility. Items are scored on a 6-point Likert scale. Scores range from 12 to 72. The higher the score the more aggression present. | Data not collected for 2 participants | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
|
From the signing of the Informed consent up to a total of approximately 9 months afterward.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T4C-SMI Group | The research intervention is Thinking for Change for prisoners with mental illness (T4C-MI). This intervention has two components. The first component is Thinking for a Change (T4C), a CBT based group intervention that includes three treatment modules delivered over the course of 25-sessions in a closed-group format to 8-12 people up to twice a week over 12-14 weeks. The second component of T4C-MI is the Targeted Service Delivery Approach (TSDA) that this research team developed for use during the delivery of T4C to compensate for the impact of the neurocognitive and social impairments associated with mental illness on participants' ability to fully engage in and understand T4C's intervention materials. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Wilson, PhD | University of North Carolina at Chapel Hill | 919-962-3598 | amyblank@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2021 | Aug 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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|
| Baseline, Month 3 |
| Change in Overall Criminal Attitudes Score | The Measure of Criminal Attitudes and Associates (MCAA) Part B is a 46-item measure. Responses are recorded in an agree/disagree format. MCAA includes four scales: attitudes toward violence, sentiments of entitlement, antisocial intent, and associates. Scores range from 0 to 46. Lower scores indicate lower levels of criminal attitudes. | Baseline, Month 3 |
| Change in Overall Impulsivity Score | Barratt Impulsiveness Scale (BIS-11) is a 30 item self-report measure. Items scored on a 4-point Likert scale. It is comprised of six subscales including attention, cognitive instability, perseverance, self-control, motor impulsiveness, and cognitive complexity. The total score ranges from 30 to 120. Lower scores indicate lower levels of impulsiveness. | Baseline, Month 3 |
| Background |
| Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. doi: 10.1002/1097-4679(199511)51:63.0.co;2-1. |
| Background | Stanford MS, Mathias CW, Dougherty DM, Lake SL, Anderson NE, Patton JH. Fifty years of the Barratt Impulsiveness Scale: An update and review. Personality and individual differences. 2009;47(5): 385-395. |
| 3387516 | Background | Raskin A. Discussion: recent developments in ascertainment and scaling of the BPRS. Psychopharmacol Bull. 1988;24(1):122-4. No abstract available. |
| 8164605 | Background | Shern DL, Wilson NZ, Coen AS, Patrick DC, Foster M, Bartsch DA, Demmler J. Client outcomes II: Longitudinal client data from the Colorado treatment outcome study. Milbank Q. 1994;72(1):123-48. |
| 37070261 | Derived | Wilson AB, Phillips J, L Villodas M, Parisi A, Dohler E, Ginley C. Assessing the Potential Efficacy of an Intervention for Incarcerated People With Mental Illness. Psychiatr Serv. 2023 Oct 1;74(10):1072-1076. doi: 10.1176/appi.ps.20220355. Epub 2023 Apr 18. |
| BG001 | Control Group | The control group receives standard prison treatment and programming |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Gender was assigned by the prison where the person was incarcerated. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Cells <5 participants were collapsed into Other/unknown to mitigate deductive disclosure. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Control Group | The control group receives standard prison treatment and programming |
|
|
| Primary | Change in Levels of Aggression Score From Baseline to Month 6 | Aggression Questionnaire - Short Form is a 12-item measure with four subscales: physical aggression, verbal aggression, anger, and hostility. Items are scored on a 6-point Likert scale. Scores range from 12 to 72. The higher the score the more aggression present. | Data not collected for 2 participants | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 6 |
|
|
|
| Primary | Number of Participants With Post Test Behavioral Infractions | Number of participants who have at least 1 behavioral infraction following the intervention. Prison records used to ascertain the number of participants who receive behavioral infractions. | Posted | Count of Participants | Participants | End of intervention through Month 9, approximately 6 months total |
|
|
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| Primary | Median Number of Days in Administrative Segregation | Prison records will be used to determine the total number of days participants are placed in administrative segregation. | Posted | Median | Inter-Quartile Range | Days | End of intervention through Month 9, approximately 6 months total |
|
|
|
| Secondary | Change in Overall Interpersonal Problem Solving Score | The Social Problem Solving Inventory - Revised, Long (SPSI-R:L) is a 52-item measure of problem solving skills and problem orientation. Items are measured on a 5-point Likert scale. It has three subscales: problem orientation, problem solving skills, and social problem-solving inventory. The total raw score range is from 0 to 20. Higher score mean more positive social problem solving skills. | Data not collected for 3 participants | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
|
|
|
| Secondary | Change in Overall Criminal Attitudes Score | The Measure of Criminal Attitudes and Associates (MCAA) Part B is a 46-item measure. Responses are recorded in an agree/disagree format. MCAA includes four scales: attitudes toward violence, sentiments of entitlement, antisocial intent, and associates. Scores range from 0 to 46. Lower scores indicate lower levels of criminal attitudes. | Data not collected for 4 participants | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
|
|
|
| Secondary | Change in Overall Impulsivity Score | Barratt Impulsiveness Scale (BIS-11) is a 30 item self-report measure. Items scored on a 4-point Likert scale. It is comprised of six subscales including attention, cognitive instability, perseverance, self-control, motor impulsiveness, and cognitive complexity. The total score ranges from 30 to 120. Lower scores indicate lower levels of impulsiveness. | Data not collected for 3 participants | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Control Group | The control group receives standard prison treatment and programming | 0 | 50 | 0 | 50 | 0 | 50 |
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