Clinical trial NCT03013738: The Effects of the GPS Program in Offenders
Official title: The Efficacy of the Growing Pro-Social (GPS) Program in Male Prison Inmates: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Prison Inmates
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 270
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. male prison inmates aged between 18 and 40 years old
2. 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.

Exclusion Criteria:

1. presence of cognitive disabilities (because GPS is not suitable for the cognitively-impaired)
2. psychotic symptoms (the experiential exercises used in the program are contraindicated for psychotic patients)
3. being treated for drug abuse/dependence (cessation or at least substantial reduction of drug or alcohol use must precede GPS treatment)
4. 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.

Primary outcomes:
measure: Early maladaptive schemas
timeFrame: From baseline to 12 months' follow-up
measure: Cognitive distortions
timeFrame: From baseline to 12 months' follow-up
Secondary outcomes:
measure: Anger
timeFrame: From baseline to 12 months' follow-up
measure: External shame
timeFrame: From baseline to 12 months' follow-up
measure: Paranoia
timeFrame: From baseline to 12 months' follow-up
measure: Emotion Regulation
timeFrame: From baseline to 12 months' follow-up
measure: Disciplinary incidents inside prison
timeFrame: From baseline to 12 months' follow-up
Other outcomes:
measure: Personality Disorders
timeFrame: Baseline
Locations:
Study officials:
References:
citation: 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.
citation: Brazao 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.
citation: Brazao 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.