Mental Health Services for Prisoners With SMI

• ClinicalTrials.gov Identifier: NCT03713398
• Recruitment Status: Completed
• First Posted: October 19, 2018
• Results First Posted: September 23, 2021
• Last Update Posted: October 27, 2021
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

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).

Condition or disease	Intervention/treatment	Phase
Mental Disorder	Behavioral: T4C-SMI	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving Mental Health Services for Prisoners With Serious Mental Illnesses
• Actual Study Start Date: January 3, 2019
• Actual Primary Completion Date: December 6, 2020
• Actual Study Completion Date: December 6, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: T4C-SMI Group; Participants will receive the T4C-SMI intervention, in addition to standard prison mental health services	Behavioral: T4C-SMI; 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.
No Intervention: Control Group; The control group receives standard prison mental health services

Outcome Measures

Primary Outcome Measures :

1. Change in Levels of Aggression Score From Baseline to Month 3 [ Time Frame: Baseline, 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.
2. Change in Levels of Aggression Score From Baseline to Month 6 [ Time Frame: Baseline, 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.
3. Number of Participants With Post Test Behavioral Infractions [ Time Frame: End of intervention through Month 9, approximately 6 months total ]
   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.
4. Median Number of Days in Administrative Segregation [ Time Frame: End of intervention through Month 9, approximately 6 months total ]
   Prison records will be used to determine the total number of days participants are placed in administrative segregation.

Secondary Outcome Measures :

1. Change in Overall Interpersonal Problem Solving Score [ Time Frame: Baseline, Month 3 ]
   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.
2. Change in Overall Criminal Attitudes Score [ Time Frame: Baseline, Month 3 ]
   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.
3. Change in Overall Impulsivity Score [ Time Frame: Baseline, Month 3 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, North Carolina

North Carolina Department of Public Safety

Raleigh, North Carolina, United States, 27699

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Amy B Wilson, PhD; UNC Chapel Hill

  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

Study Protocol and Statistical Analysis Plan  [PDF] June 15, 2021

More Information

Publications:

Bryant FB, Smith BD. Aggression Questionnaire--Short Form. Psyctests. 2001. doi:10.1037/t09754-000

D'Zurilla TJ, Nezu AM, Maydeu-Olivares A (n.d). Social Problem-Solving Inventory - Revised. Psyctests. doi:10.1037/t05068-000

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.

Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74.

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.

Raskin A. Discussion: recent developments in ascertainment and scaling of the BPRS. Psychopharmacol Bull. 1988;24(1):122-4.

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.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03713398
• Other Study ID Numbers: 16-3154; R34MH111855 ( U.S. NIH Grant/Contract )
• First Posted: October 19, 2018
• Results First Posted: September 23, 2021
• Last Update Posted: October 27, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Mental Disorders