NCT03713398

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 3, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2020

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 23, 2021

Completed
Last Updated

October 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

October 15, 2018

Results QC Date

August 27, 2021

Last Update Submit

October 8, 2021

Conditions

Mental Disorder

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (3)

  • Change in Overall Interpersonal Problem Solving Score

    Baseline, Month 3

  • Change in Overall Criminal Attitudes Score

    Baseline, Month 3

  • Change in Overall Impulsivity Score

    Baseline, Month 3

Study Arms (2)

T4C-SMI Group

EXPERIMENTAL

Participants will receive the T4C-SMI intervention, in addition to standard prison mental health services

Behavioral: T4C-SMI

Control Group

NO INTERVENTION

The control group receives standard prison mental health services

Interventions

T4C-SMIBEHAVIORAL

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.

T4C-SMI Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • has participated in T4C-SMI within 6 months prior to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina Department of Public Safety

Raleigh, North Carolina, 27699, United States

Location

Related Publications (8)

  • 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

    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.

    PMID: 12216781BACKGROUND

  • 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.

    PMID: 8778124BACKGROUND

  • 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.

    BACKGROUND

  • Raskin A. Discussion: recent developments in ascertainment and scaling of the BPRS. Psychopharmacol Bull. 1988;24(1):122-4. No abstract available.

    PMID: 3387516BACKGROUND

  • 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.

    PMID: 8164605BACKGROUND

  • 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.

    PMID: 37070261DERIVED

MeSH Terms

Conditions

Mental Disorders

Results Point of Contact

Title
Amy Wilson, PhD
Organization
University of North Carolina at Chapel Hill
amyblank@email.unc.edu
919-962-3598

Study Officials

  • Amy B Wilson, PhD

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 19, 2018

Study Start

January 3, 2019

Primary Completion

December 6, 2020

Study Completion

December 6, 2020

Last Updated

October 27, 2021

Results First Posted

September 23, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)