Mental DisorderNCT03713398
Mental Health Services for Prisoners With SMI
A study testing T4C-SMI in people with Mental Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorder
- What is being tested?
- T4C-SMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 6 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- has participated in T4C-SMI within 6 months prior to study
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Department of Public Safety
Raleigh, North Carolina, 27699
About this study
Official title: Improving Mental Health Services for Prisoners With Serious Mental Illnesses
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).
Read the 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.
- Conditions
- Mental Disorder
- Being tested
- T4C-SMI
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T4C-SMIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| T4C-SMI Group | Experimental | Participants will receive the T4C-SMI intervention, in addition to standard prison mental health services Receives: Behavioral: T4C-SMI |
| Control Group | No intervention | The control group receives standard prison mental health services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of intervention through Month 9, approximately 6 months total
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start3 Jan 2019
- Primary completion6 Dec 2020
- Study completion6 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Amy B Wilson, PhD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713398
- Sponsor's protocol ID
- 16-3154
- Other IDs
- R34MH111855
- Status last verified
- Aug 2021
- First submitted
- 15 Oct 2018
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1177/1073191102009003003.
PubMed 12216781Patton 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.
PubMed 8778124Stanford 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. No abstract available.
PubMed 3387516Shern 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.
PubMed 8164605Wilson 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.
PubMed 37070261
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Health Services for Prisoners With Serious Mental Illnesses
- ClinicalTrials.gov ID
- NCT03713398
- Acronym / sponsor ID
- 16-3154
- Conditions
- Mental Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 6 Dec 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 23 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T4C-SMI Group | Experimental | Behavioral: T4C-SMIParticipants will receive the T4C-SMI intervention, in addition to standard prison mental health services |
| Control Group | No intervention | –The control group receives standard prison mental health services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- has participated in T4C-SMI within 6 months prior to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T4C-SMIT4C-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. | Behavioural | T4C-SMI Group |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Change in Overall Interpersonal Problem Solving Score
Time frame: Baseline, Month 3
Change in Overall Criminal Attitudes Score
Time frame: Baseline, Month 3
Change in Overall Impulsivity Score
Time frame: Baseline, Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBryant FB, Smith BD. Aggression Questionnaire--Short Form. Psyctests. 2001. doi:10.1037/t09754-000
- BackgroundD'Zurilla TJ, Nezu AM, Maydeu-Olivares A (n.d). Social Problem-Solving Inventory - Revised. Psyctests. doi:10.1037/t05068-000
- Background: PubMed 12216781Mills 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.
- Background: PubMed 8778124Patton 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.
- BackgroundStanford 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.
- Background: PubMed 3387516Raskin A. Discussion: recent developments in ascertainment and scaling of the BPRS. Psychopharmacol Bull. 1988;24(1):122-4. No abstract available.
- Background: PubMed 8164605Shern 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.
- Derived from this study: PubMed 37070261Wilson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy B Wilson, PhD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T4C-SMI in people with Mental Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Levels of Aggression Score From Baseline to Month 3 (time frame: Baseline, Month 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713398, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.