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临床试验/NCT03013738
NCT03013738已完成不适用

The Efficacy of the Growing Pro-Social (GPS) Program in Male Prison Inmates: A Randomized Controlled Trial

University of Coimbra0 个研究点目标入组 270 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
270
主要终点
Cognitive distortions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Cognitive distortions

时间窗: 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.

Early maladaptive schemas

时间窗: 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.

次要结局

  • Paranoia(From baseline to 12 months' follow-up)
  • External shame(From baseline to 12 months' follow-up)
  • Anger(From baseline to 12 months' follow-up)
  • Emotion Regulation(From baseline to 12 months' follow-up)
  • Disciplinary incidents inside prison(From baseline to 12 months' follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nelio Brazao

MSc

University of Coimbra

相似试验

The Effects of the GPS Program in Offenders | 临床试验