Mental Health Services for Prisoners With SMI
Primary Purpose
Mental Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
T4C-SMI
Sponsored by
About this trial
This is an interventional health services research trial for Mental Disorder
Eligibility Criteria
Inclusion Criteria:
- aged 18 years or older
- have a diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder, bipolar disorder with psychotic features or major depressive disorder with psychotic features
- have moderate to high risk levels of criminogenic risk factors as determined by the Level of Service and Case Management Inventory (LS/CMI)
- have at least one year or more remaining on their prison sentence at the time of the screening interview
Exclusion Criteria:
- has participated in T4C-SMI within 6 months prior to study
Sites / Locations
- North Carolina Department of Public Safety
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
T4C-SMI Group
Control Group
Arm Description
Participants will receive the T4C-SMI intervention, in addition to standard prison mental health services
The control group receives standard prison mental health services
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03713398
First Posted
October 15, 2018
Last Updated
October 8, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03713398
Brief Title
Mental Health Services for Prisoners With SMI
Official Title
Improving Mental Health Services for Prisoners With Serious Mental Illnesses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
December 6, 2020 (Actual)
Study Completion Date
December 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T4C-SMI Group
Arm Type
Experimental
Arm Description
Participants will receive the T4C-SMI intervention, in addition to standard prison mental health services
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group receives standard prison mental health services
Intervention Type
Behavioral
Intervention Name(s)
T4C-SMI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Levels of Aggression Score From Baseline to Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Change in Levels of Aggression Score From Baseline to Month 6
Description
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.
Time Frame
Baseline, Month 6
Title
Number of Participants With Post Test Behavioral Infractions
Description
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.
Time Frame
End of intervention through Month 9, approximately 6 months total
Title
Median Number of Days in Administrative Segregation
Description
Prison records will be used to determine the total number of days participants are placed in administrative segregation.
Time Frame
End of intervention through Month 9, approximately 6 months total
Secondary Outcome Measure Information:
Title
Change in Overall Interpersonal Problem Solving Score
Description
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.
Time Frame
Baseline, Month 3
Title
Change in Overall Criminal Attitudes Score
Description
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.
Time Frame
Baseline, Month 3
Title
Change in Overall Impulsivity Score
Description
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.
Time Frame
Baseline, Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18 years or older
have a diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder, bipolar disorder with psychotic features or major depressive disorder with psychotic features
have moderate to high risk levels of criminogenic risk factors as determined by the Level of Service and Case Management Inventory (LS/CMI)
have at least one year or more remaining on their prison sentence at the time of the screening interview
Exclusion Criteria:
has participated in T4C-SMI within 6 months prior to study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy B Wilson, PhD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Carolina Department of Public Safety
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27699
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Bryant FB, Smith BD. Aggression Questionnaire--Short Form. Psyctests. 2001. doi:10.1037/t09754-000
Results Reference
background
Citation
D'Zurilla TJ, Nezu AM, Maydeu-Olivares A (n.d). Social Problem-Solving Inventory - Revised. Psyctests. doi:10.1037/t05068-000
Results Reference
background
PubMed Identifier
12216781
Citation
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.
Results Reference
background
PubMed Identifier
8778124
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
3387516
Citation
Raskin A. Discussion: recent developments in ascertainment and scaling of the BPRS. Psychopharmacol Bull. 1988;24(1):122-4. No abstract available.
Results Reference
background
PubMed Identifier
8164605
Citation
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.
Results Reference
background
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Mental Health Services for Prisoners With SMI
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