Male Prison InmatesGPSNCT03013738
The Effects of the GPS Program in Offenders
A study testing Growing Pro-Social Program and Treatment As Usual in people with Male Prison Inmates, run by University of Coimbra.
Trial summary
This randomized controlled trial aimed to assess the efficacy of a 40-session cognitive-behavioral group program, Growing Pro-Social (GPS), in reducing early maladaptive schemas and cognitive distortions (primary outcomes), as well as anger, shame and paranoia (secondary outcomes). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Prison Inmates
- What is being tested?
- Growing Pro-Social Program and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male prison inmates aged between 18 and 40 years old
- remaining in prison for at least 24 months (taking into account GPS's 12-month length and 12-month follow-up assessment), since the beginning of the program.
Who cannot join
- presence of cognitive disabilities (because GPS is not suitable for the cognitively-impaired)
- psychotic symptoms (the experiential exercises used in the program are contraindicated for psychotic patients)
- being treated for drug abuse/dependence (cessation or at least substantial reduction of drug or alcohol use must precede GPS treatment)
- being sentenced exclusively for sexual offenses (sex offenders would benefit from more specific intervention programs)
- NOTE: Female offenders were also excluded from the sample because women represent less than 6% of the total inmates in Portugal, and any possible idiosyncrasies from this cohort would be underrepresented.
About this study
Official title: The Efficacy of the Growing Pro-Social (GPS) Program in Male Prison Inmates: A Randomized Controlled Trial
This randomized controlled trial aimed to assess the efficacy of a 40-session cognitive-behavioral group program, Growing Pro-Social (GPS), in reducing early maladaptive schemas and cognitive distortions (primary outcomes), as well as anger, shame and paranoia (secondary outcomes). The GPS's impact on behavioral change (e.g., in the reduction of disciplinary incidents and prison records) was also tested, in order to ascertain if changes observed in cognitive and emotional variables were reflected in a more adjusted behavioral pattern. Personality Disorders were also tested as moderators of treatment effects.
Read the detailed description
This was a randomized controlled trial with blind assessments, carried out in nine prisons in three city areas in mainland Portugal (Lisbon, Oporto and Coimbra) and in the Madeira Island.
After the study was approved by the Head of the General Directorate of Reintegration and Prison Services of the Portuguese Ministry of Justice, a list of potential participants who did not meet the exclusion criteria was made available to the research team by psychologists from the justice system. Next, a large sample of participants was randomly selected using a random number table by a research assistant who was blind to any personal information about each inmate. Then, a first meeting between the research team and the randomized inmates occurred, in which researchers invited inmates to participate voluntarily. In this meeting, researchers explained the goals of the study and presented a brief overview of the intervention program. It was also explained to inmates that their participation in the study would not impact their sentencing in any way.
Participants who agreed to participate, gave written informed consent, completed the baseline assessment, and were randomly assigned to treatment conditions (treatment and control groups) using a random number table by a research assistant who was blind to any information about each participant. Afterwards, the research team informed the psychologists in each prison of the result of the randomization so that GPS could be initiated. Participants in the control group were informed that they would be offered the GPS treatment after the study's completion (including the follow-up period).
Besides baseline assessment, participants completed the mid-assessment (after the 20th session of the program), post-treatment assessment (at the end of GPS) and follow-up assessment (12 months after GPS completion). Staff who conducted randomization did not serve as therapists or accessors, and accessors were blind to condition assignment. Respondent-specific codes were used to link the data from one time-point to the next one.
GPS's facilitators were chosen among the psychologists who already had training and experience in delivering the program with inmates (who were not selected for this study). In order to assure program integrity and consistency, facilitators received regular supervision by the research team (including the program's main author) during the time GPS was run in prisons. Moreover, the program's structured and manualized design ensures integrity, at least partially.
- Conditions
- Male Prison Inmates
- Being tested
- Growing Pro-Social Program, Treatment As Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growing Pro-Social ProgramBehavioural
GPS is a structured cognitive-behavioral group program aimed to reduce the prominence of early maladaptive schemas
Treatment As UsualOther
TAU in Portuguese prisons is primarily aimed to increase educational and professional qualifications
| Study group | Role | What they receive |
|---|---|---|
| Growing Pro-Social (GPS) program | Experimental | The Growing Pro-Social (GPS) program is a cognitive-behavioral group program for offenders. GPS is based on schema therapy, which conceptualizes aggressiveness as a result of a distorted view of the self and of the others. The ultimate goal of the GPS is to promote change in dysfunctional core beliefs about the self and the others.
GPS consists of 40 sessions, each lasting about 90 minutes. Sessions must be carried out by two therapists who should be skillful in schema therapy. Sessions are grouped into five modules: (1) human communication, (2) interpersonal relationships, (3) cognitive distortions, (4) function and meaning of emotions, and (5) early maladaptive schemas.
The treatment group attended the GPS program in addition to the Treatment AsUsual (TAU) delivered at Portuguese prisons. Receives: Behavioral: Growing Pro-Social Program; Other: Treatment As Usual |
| Treatment As Usual | Other | Subjects in this group received Treatment As Usual in Portuguese prisons (supervision of school frequency, occupational and job-related tasks and sentence planning supervision over time) and did not attend the GPS program or any other structured program during the research period. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early maladaptive schemas
Participants reported on a questionnaire of early mal-adaptive schemas (EMSs), the Young Schema Questionnaire - YSQ-S3 (Young, 2005). The YSQ-S3 is a widely-used self-report questionnaire including 90 items, measuring the 18 EMSs proposed by Young (1990). Each EMS is evaluated using a set of five items listed randomly, which the individual rates using a Likert-type scale from 1 (completely untrue to me) to 6 (describes me perfectly).
This assessment was carried out by researchers, who received training in the self-report measure.
Measured: From baseline to 12 months' follow-up
Cognitive distortions
Participants reported on a questionnaire of cognitive distortions, the Angry Cognitions Scale - ACS (Martin \& Dahlen, 2007). The ACS consists of 54 items distributed across nine scenarios (e.g., "You get home from the drive-thru and realized that you were given the wrong food"). Participants are asked to imagine that the situation described in each scenario had just happened. For each scenario, there are six items referring to different thoughts that could arise during the situation, which can be rated on a five-point Likert-type scale (1 = very unlikely to 5 = very likely).
This assessment was carried out by researchers, who received training in the self-report measure.
Measured: From baseline to 12 months' follow-up
Secondary outcomes (5)
Anger
Participants reported on a questionnaire of anger, the State-Trait Anger Expression Inventory - STAXI (Spielberger, 1988). The STAXI is a 44-item questionnaire divided into three parts: the first part assesses anger-state (how one feels in the present moment), the second part assesses anger-trait (how one generally feels), and the third part assesses anger-expression (how one generally reacts or behaves when feeling enraged or angry. Anger-trait encompasses two factors (temperament and angry-reaction), and anger-expression is composed by three factors (anger-in, anger-out and anger-control). Each item is rated on a four-point scale (1 = not at all to 4 = almost always).
This assessment was carried out by researchers, who received training in the self-report measure.
Measured: From baseline to 12 months' follow-up
External shame
Participants reported on a questionnaire of external shame, the Other as Shamer Scale - OAS (Allan, Gilbert, \& Goss, 1994). The OAS is an 18-item scale that assesses external shame (i.e., subject's perception of being negatively judged by others). Each item is rated on a five-point scale (0 = never to 4 = almost always) according to how frequently the individual feels s/he is being judged by others (e.g., "Other people seem me as small and insignificant").
This assessment was carried out by researchers, who received training in the self-report measure.
Measured: From baseline to 12 months' follow-up
Paranoia
Participants reported on a questionnaire of paranoia, the Paranoia Scale - PS (Fenigstein \& Vanable, 1992). The PS is a 20-item self-report measure that assesses paranoid ideation. Items are rated on a five-point Likert scale (1 = not at all applicable to 5 = extremely applicable), where higher scores suggest high paranoid ideation.
This assessment was carried out by researchers, who received training in the self-report measure.
Measured: From baseline to 12 months' follow-up
Emotion Regulation
Participants reported on a questionnaire of emotional regulation, the Emotion Regulation Questionnaire - ERQ (Gross \& John, 2003). The ERQ is a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).
This assessment was carried out by researchers, who received training in the self-report measure.
Measured: From baseline to 12 months' follow-up
Disciplinary incidents inside prison
For estimation of the frequency and type of disciplinary incidents and infractions, the individual records of each participant was collected from the prison records, describing their frequency and type during the research period.
Measured: From baseline to 12 months' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startMay 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Male Prison InmatesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelio Brazao, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013738
- Sponsor's protocol ID
- CINEICC-1-NB
- Other IDs
- SFRH/BD/89283/2012
- Acronym
- GPS
- Status last verified
- Jan 2017
- First submitted
- 4 Jan 2017
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
PubMed 32880104Brazao N, Rijo D, Salvador MDC, Pinto-Gouveia J. The effects of the growing pro-social program on cognitive distortions and early maladaptive schemas over time in male prison inmates: A randomized controlled trial. J Consult Clin Psychol. 2017 Nov;85(11):1064-1079. doi: 10.1037/ccp0000247.
PubMed 29083222Brazao N, Rijo D, Salvador MDC, Pinto-Gouveia J. Promoting emotion and behavior regulation in male prison inmates: A secondary data analysis from a randomized controlled trial testing the efficacy of the growing pro-social program. Law Hum Behav. 2018 Feb;42(1):57-70. doi: 10.1037/lhb0000267. Epub 2017 Oct 26.
PubMed 29072472
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Growing Pro-Social (GPS) Program in Male Prison Inmates: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03013738
- Acronym / sponsor ID
- GPS / CINEICC-1-NB
- Conditions
- Male Prison Inmates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aimed to assess the efficacy of a 40-session cognitive-behavioral group program, Growing Pro-Social (GPS), in reducing early maladaptive schemas and cognitive distortions (primary outcomes), as well as anger, shame and paranoia (secondary outcomes). The GPS's impact on behavioral change (e.g., in the reduction of disciplinary incidents and prison records) was also tested, in order to ascertain if changes observed in cognitive and emotional variables were reflected in a more adjusted behavioral pattern. Personality Disorders were also tested as moderators of treatment effects.
Detailed description
This was a randomized controlled trial with blind assessments, carried out in nine prisons in three city areas in mainland Portugal (Lisbon, Oporto and Coimbra) and in the Madeira Island.
After the study was approved by the Head of the General Directorate of Reintegration and Prison Services of the Portuguese Ministry of Justice, a list of potential participants who did not meet the exclusion criteria was made available to the research team by psychologists from the justice system. Next, a large sample of participants was randomly selected using a random number table by a research assistant who was blind to any personal information about each inmate. Then, a first meeting between the research team and the randomized inmates occurred, in which researchers invited inmates to participate voluntarily. In this meeting, researchers explained the goals of the study and presented a brief overview of the intervention program. It was also explained to inmates that their participation in the study would not impact their sentencing in any way.
Participants who agreed to participate, gave written informed consent, completed the baseline assessment, and were randomly assigned to treatment conditions (treatment and control groups) using a random number table by a research assistant who was blind to any information about each participant. Afterwards, the research team informed the psychologists in each prison of the result of the randomization so that GPS could be initiated. Participants in the control group were informed that they would be offered the GPS treatment after the study's completion (including the follow-up period).
Besides baseline assessment, participants completed the mid-assessment (after the 20th session of the program), post-treatment assessment (at the end of GPS) and follow-up assessment (12 months after GPS completion). Staff who conducted randomization did not serve as therapists or accessors, and accessors were blind to condition assignment. Respondent-specific codes were used to link the data from one time-point to the next one.
GPS's facilitators were chosen among the psychologists who already had training and experience in delivering the program with inmates (who were not selected for this study). In order to assure program integrity and consistency, facilitators received regular supervision by the research team (including the program's main author) during the time GPS was run in prisons. Moreover, the program's structured and manualized design ensures integrity, at least partially.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growing Pro-Social (GPS) program | Experimental | Behavioral: Growing Pro-Social Program, Other: Treatment As UsualThe Growing Pro-Social (GPS) program is a cognitive-behavioral group program for offenders. GPS is based on schema therapy, which conceptualizes aggressiveness as a result of a distorted view of the self and of the others. The ultimate goal of the GPS is to promote change in dysfunctional core beliefs about the self and the others. GPS consists of 40 sessions, each lasting about 90 minutes. Sessions must be carried out by two therapists who should be skillful in schema therapy. Sessions are grouped into five modules: (1) human communication, (2) interpersonal relationships, (3) cognitive distortions, (4) function and meaning of emotions, and (5) early maladaptive schemas. The treatment group attended the GPS program in addition to the Treatment AsUsual (TAU) delivered at Portuguese prisons. |
| Treatment As Usual | Other | Other: Treatment As UsualSubjects in this group received Treatment As Usual in Portuguese prisons (supervision of school frequency, occupational and job-related tasks and sentence planning supervision over time) and did not attend the GPS program or any other structured program during the research period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male prison inmates aged between 18 and 40 years old
- remaining in prison for at least 24 months (taking into account GPS's 12-month length and 12-month follow-up assessment), since the beginning of the program.
Key exclusion criteria (5 listed)
- presence of cognitive disabilities (because GPS is not suitable for the cognitively-impaired)
- psychotic symptoms (the experiential exercises used in the program are contraindicated for psychotic patients)
- being treated for drug abuse/dependence (cessation or at least substantial reduction of drug or alcohol use must precede GPS treatment)
- being sentenced exclusively for sexual offenses (sex offenders would benefit from more specific intervention programs)
- NOTE: Female offenders were also excluded from the sample because women represent less than 6% of the total inmates in Portugal, and any possible idiosyncrasies from this cohort would be underrepresented.
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 |
|---|---|---|
| Growing Pro-Social ProgramGPS is a structured cognitive-behavioral group program aimed to reduce the prominence of early maladaptive schemas | Behavioural | Growing Pro-Social (GPS) program |
| Treatment As UsualTAU in Portuguese prisons is primarily aimed to increase educational and professional qualifications | Other | Growing Pro-Social (GPS) program, Treatment As Usual |
Primary outcome
Early maladaptive schemas
Time frame: From baseline to 12 months' follow-up
Participants reported on a questionnaire of early mal-adaptive schemas (EMSs), the Young Schema Questionnaire - YSQ-S3 (Young, 2005). The YSQ-S3 is a widely-used self-report questionnaire including 90 items, measuring the 18 EMSs proposed by Young (1990). Each EMS is evaluated using a set of five items listed randomly, which the individual rates using a Likert-type scale from 1 (completely untrue to me) to 6 (describes me perfectly). This assessment was carried out by researchers, who received training in the self-report measure.
Cognitive distortions
Time frame: From baseline to 12 months' follow-up
Participants reported on a questionnaire of cognitive distortions, the Angry Cognitions Scale - ACS (Martin \& Dahlen, 2007). The ACS consists of 54 items distributed across nine scenarios (e.g., "You get home from the drive-thru and realized that you were given the wrong food"). Participants are asked to imagine that the situation described in each scenario had just happened. For each scenario, there are six items referring to different thoughts that could arise during the situation, which can be rated on a five-point Likert-type scale (1 = very unlikely to 5 = very likely). This assessment was carried out by researchers, who received training in the self-report measure.
5 secondary outcomes
Anger
Time frame: From baseline to 12 months' follow-up
External shame
Time frame: From baseline to 12 months' follow-up
Paranoia
Time frame: From baseline to 12 months' follow-up
Emotion Regulation
Time frame: From baseline to 12 months' follow-up
Disciplinary incidents inside prison
Time frame: From baseline to 12 months' follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Derived from this study: PubMed 32880104Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
- Derived from this study: PubMed 29083222Brazao N, Rijo D, Salvador MDC, Pinto-Gouveia J. The effects of the growing pro-social program on cognitive distortions and early maladaptive schemas over time in male prison inmates: A randomized controlled trial. J Consult Clin Psychol. 2017 Nov;85(11):1064-1079. doi: 10.1037/ccp0000247.
- Derived from this study: PubMed 29072472Brazao N, Rijo D, Salvador MDC, Pinto-Gouveia J. Promoting emotion and behavior regulation in male prison inmates: A secondary data analysis from a randomized controlled trial testing the efficacy of the growing pro-social program. Law Hum Behav. 2018 Feb;42(1):57-70. doi: 10.1037/lhb0000267. Epub 2017 Oct 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Growing Pro-Social Program and Treatment As Usual in people with Male Prison Inmates, run by University of Coimbra.
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 2 inclusion and 5 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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Early maladaptive schemas (time frame: From baseline to 12 months' follow-up). The study lists 2 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 NCT03013738, which also lists 3 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 6 Jan 2017.