Trial Outcomes & Findings for Mental Health Services for Prisoners With SMI (NCT NCT03713398)
NCT ID: NCT03713398
Last Updated: 2021-10-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Baseline, Month 3
Results posted on
2021-10-27
Participant Flow
Participant milestones
| Measure |
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.
|
Control Group
The control group receives standard prison treatment and programming
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
26
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mental Health Services for Prisoners With SMI
Baseline characteristics by cohort
| Measure |
T4C-SMI Group
n=50 Participants
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.
|
Control Group
n=50 Participants
The control group receives standard prison treatment and programming
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
18 years and older
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/unknown
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: Data not collected for 2 participants
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.
Outcome measures
| Measure |
T4C-SMI Group
n=22 Participants
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.
|
Control Group
n=23 Participants
The control group receives standard prison treatment and programming
|
|---|---|---|
|
Change in Levels of Aggression Score From Baseline to Month 3
|
-4.81 score on a scale
Standard Error 2.34
|
-2.68 score on a scale
Standard Error 2.32
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Data not collected for 2 participants
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.
Outcome measures
| Measure |
T4C-SMI Group
n=22 Participants
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.
|
Control Group
n=23 Participants
The control group receives standard prison treatment and programming
|
|---|---|---|
|
Change in Levels of Aggression Score From Baseline to Month 6
|
-9.16 score on a scale
Standard Error 2.57
|
-5.21 score on a scale
Standard Error 2.59
|
PRIMARY outcome
Timeframe: End of intervention through Month 9, approximately 6 months totalNumber 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.
Outcome measures
| Measure |
T4C-SMI Group
n=24 Participants
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.
|
Control Group
n=23 Participants
The control group receives standard prison treatment and programming
|
|---|---|---|
|
Number of Participants With Post Test Behavioral Infractions
Received infraction
|
8 Participants
|
6 Participants
|
|
Number of Participants With Post Test Behavioral Infractions
No infraction
|
16 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: End of intervention through Month 9, approximately 6 months totalPrison records will be used to determine the total number of days participants are placed in administrative segregation.
Outcome measures
| Measure |
T4C-SMI Group
n=24 Participants
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.
|
Control Group
n=23 Participants
The control group receives standard prison treatment and programming
|
|---|---|---|
|
Median Number of Days in Administrative Segregation
|
0 Days
Interval 0.0 to 20.0
|
0 Days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Data not collected for 3 participants
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.
Outcome measures
| Measure |
T4C-SMI Group
n=22 Participants
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.
|
Control Group
n=22 Participants
The control group receives standard prison treatment and programming
|
|---|---|---|
|
Change in Overall Interpersonal Problem Solving Score
|
1.38 score on a scale
Standard Error 0.48
|
0.68 score on a scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Data not collected for 4 participants
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.
Outcome measures
| Measure |
T4C-SMI Group
n=22 Participants
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.
|
Control Group
n=21 Participants
The control group receives standard prison treatment and programming
|
|---|---|---|
|
Change in Overall Criminal Attitudes Score
|
-5.32 score on a scale
Standard Error 1.56
|
-1.68 score on a scale
Standard Error 1.51
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Data not collected for 3 participants
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.
Outcome measures
| Measure |
T4C-SMI Group
n=22 Participants
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.
|
Control Group
n=22 Participants
The control group receives standard prison treatment and programming
|
|---|---|---|
|
Change in Overall Impulsivity Score
|
-7.61 score on a scale
Standard Error 2.02
|
-0.51 score on a scale
Standard Error 2.03
|
Adverse Events
T4C-SMI Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amy Wilson, PhD
University of North Carolina at Chapel Hill
Phone: 919-962-3598
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place