The Effects of the GPS Program in Offenders (GPS)
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ClinicalTrials.gov Identifier: NCT03013738 |
Recruitment Status :
Completed
First Posted : January 6, 2017
Last Update Posted : January 6, 2017
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Tracking Information | |||
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First Submitted Date ICMJE | January 4, 2017 | ||
First Posted Date ICMJE | January 6, 2017 | ||
Last Update Posted Date | January 6, 2017 | ||
Study Start Date ICMJE | May 2013 | ||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures |
Personality Disorders [ Time Frame: Baseline ] Participants were interviewed with the SCID-II - Structured Clinical Interview for DSM-IV Axis II Personality Disorders (First, Gibbon, Spitzer, Williams, & Benjamim, 1997), a widely known semistructured diagnostic interview which assesses 10 Axis II Personality Disorders from the DSM-IV (APA, 2000), and the Depressive and Passive-Aggressive Personality Disorders (included in DSM-IV's appendix).
This assessment was carried out by researchers who had special training in the diagnosis of Personality Disorders and previous experience administering the SCID-II interview.
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Original Other Pre-specified Outcome Measures | Same as current | ||
Descriptive Information | |||
Brief Title ICMJE | The Effects of the GPS Program in Offenders | ||
Official Title ICMJE | The Efficacy of the Growing Pro-Social (GPS) Program in Male Prison Inmates: A Randomized Controlled Trial | ||
Brief 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). 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. |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Male Prison Inmates | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
270 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | July 2016 | ||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 40 Years (Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT03013738 | ||
Other Study ID Numbers ICMJE | CINEICC-1-NB SFRH/BD/89283/2012 ( Other Grant/Funding Number: Portuguese Foundation for Science and Technology ) |
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Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Nelio Brazao, University of Coimbra | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | University of Coimbra | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | University of Coimbra | ||
Verification Date | January 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |