Mental Disorder
Conditions
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.
Interventions
BEHAVIORALT4C-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.
Sponsors
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Levels of Aggression Score From Baseline to Month 3 | 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. |
| Change in Levels of Aggression Score From Baseline to Month 6 | 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. |
| Number of Participants With Post Test Behavioral Infractions | 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. |
| Median Number of Days in Administrative Segregation | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Criminal Attitudes Score | 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. |
| Change in Overall Impulsivity Score | 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. |
| Change in Overall Interpersonal Problem Solving Score | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Control Group The control group receives standard prison treatment and programming | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | T4C-SMI Group | Control Group | Total |
|---|---|---|---|
| Age, Customized < 18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 18 years and older | 50 Participants | 50 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 7 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 43 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 19 Participants | 14 Participants | 33 Participants |
| Race/Ethnicity, Customized More than one race | 8 Participants | 9 Participants | 17 Participants |
| Race/Ethnicity, Customized Other/unknown | 7 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 21 Participants | 37 Participants |
| Region of Enrollment United States | 50 Participants | 50 Participants | 100 Participants |
| Sex/Gender, Customized Female | 14 Participants | 14 Participants | 28 Participants |
| Sex/Gender, Customized Male | 36 Participants | 36 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: Baseline, Month 3
Population: Data not collected for 2 participants
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T4C-SMI Group | Change in Levels of Aggression Score From Baseline to Month 3 | -4.81 score on a scale | Standard Error 2.34 |
| Control Group | Change in Levels of Aggression Score From Baseline to Month 3 | -2.68 score on a scale | Standard Error 2.32 |
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.
Time frame: Baseline, Month 6
Population: Data not collected for 2 participants
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T4C-SMI Group | Change in Levels of Aggression Score From Baseline to Month 6 | -9.16 score on a scale | Standard Error 2.57 |
| Control Group | Change in Levels of Aggression Score From Baseline to Month 6 | -5.21 score on a scale | Standard Error 2.59 |
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.
Time frame: End of intervention through Month 9, approximately 6 months total
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| T4C-SMI Group | Median Number of Days in Administrative Segregation | 0 Days |
| Control Group | Median Number of Days in Administrative Segregation | 0 Days |
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.
Time frame: End of intervention through Month 9, approximately 6 months total
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| T4C-SMI Group | Number of Participants With Post Test Behavioral Infractions | Received infraction | 8 Participants |
| T4C-SMI Group | Number of Participants With Post Test Behavioral Infractions | No infraction | 16 Participants |
| Control Group | Number of Participants With Post Test Behavioral Infractions | Received infraction | 6 Participants |
| Control Group | Number of Participants With Post Test Behavioral Infractions | No infraction | 17 Participants |
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.
Time frame: Baseline, Month 3
Population: Data not collected for 4 participants
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T4C-SMI Group | Change in Overall Criminal Attitudes Score | -5.32 score on a scale | Standard Error 1.56 |
| Control Group | Change in Overall Criminal Attitudes Score | -1.68 score on a scale | Standard Error 1.51 |
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.
Time frame: Baseline, Month 3
Population: Data not collected for 3 participants
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T4C-SMI Group | Change in Overall Impulsivity Score | -7.61 score on a scale | Standard Error 2.02 |
| Control Group | Change in Overall Impulsivity Score | -0.51 score on a scale | Standard Error 2.03 |
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.
Time frame: Baseline, Month 3
Population: Data not collected for 3 participants
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T4C-SMI Group | Change in Overall Interpersonal Problem Solving Score | 1.38 score on a scale | Standard Error 0.48 |
| Control Group | Change in Overall Interpersonal Problem Solving Score | 0.68 score on a scale | Standard Error 0.48 |