An interventional study of PSYCHOPATHY.COMP program. and Treatment As Usual - TAU in Psychopathic Personality Trait, Conduct Disorder and Delinquency, sponsored by University of Coimbra. Completed at 1 site in Portugal. Open to male participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-27.
Sponsored by University of Coimbra · Not applicable, Interventional, and Treatment
This non-randomized controlled trial with a control group aimed to assess the efficacy of a 20-session individualized Compassion Focused Therapy-based intervention, the PSYCHOPATHY.COMP, in reducing psychopathic traits (primary outcomes), aggression, shame, emotion regulation problems, and fears of compassion, as well as in increasing social safeness, self-compassion, and compassion towards others (secondary outcomes). The PSYCHOPATHY.COMP's impact on psychophysiological (i.e., Heart Rate/Heart Rate Variability) and behavioral indicators (i.e., number disciplinary infractions and number of days in punishment) were also tested, in order to ascertain if changes observed in self-report questionnaires were reflected in more adjusted psychophysiological and behavioral patterns. Mental Health disorders, as well as the number of Conduct Disorder criteria, were also tested as moderators of treatment effects.
This was a non-randomized controlled trial with a control group carried out in the six Portuguese juvenile detention facilities aimed to test the efficacy of an individual Compassion Focused-based intervention (the PSYCHOPATHY.COMP program) in detained youth.
The ethics committee of the Faculty of Psychology and Educational Sciences of the University of Coimbra, the National Data Protection Agency, and the Portuguese Ministry of Justice approved the study's procedures. Portuguese juvenile detention facilities usually have no more than 150 detained youth (about 30 youth per juvenile detention facility), facing 6 to 36 months of detention, around 10 youth enter and leave Portuguese juvenile detention facilities per month, which makes it difficult to randomly assign participants to conditions. To try to minimize this roadblock and to maximize time and human resources, the research team opted to assign the first 60 youth entering in the juvenile detention facilities during the research period to the treatment group and the following 60 youth to the control group. Participants in the treatment group attended the PSYCHOPATHY.COMP program for about 6 months in addition to the treatment as usual (TAU) delivered at Portuguese juvenile detention facilities. The TAU in Portuguese juvenile detention facilities is primarily aimed to increase educational and professional qualifications, as well as to promote behavioral regulation and encompasses: school frequency, a token economy system for behavior control, the frequency of a cognitive-behavioral group program (the GPS-Growing Pro-Social; Rijo et al., 2007) and individual counseling sessions delivered by psychologists from the juvenile justice system (the treatment group would not attend these sessions). Participants in the control group received TAU, including the individual counseling sessions delivered by psychologists from the juvenile justice system, and did not attend the PSYCHOPATHY.COMP during the research period.
Researchers invited detained youth to voluntarily participate in the study, explained its goals, and presented a brief overview of the intervention program. Confidentiality and anonymity were guaranteed. It was also explained to detained youth that their participation in the study would not impact on their sentencing/school grades in any possible way. Participants who agreed to participate gave written informed consent, in addition to their parents/legal guardians' written consent, and completed the baseline assessment. Participants in the control group were informed that they would benefit from the individualized counseling sessions by the psychologists from the juvenile detention facilities.
Participants in the treatment group were assessed before the first session of the program (baseline assessment), right after its terminus (i.e., post-treatment assessment - about 6 months after the baseline assessment), and 6 months after PSYCHOPATHY.COMP completion (follow-up assessment). Participants in the control group were assessed with the same time intervals. Independent research assistants blind to condition assignment participated in data collection. Respondent-specific codes were used to link the data from one time-point to the next one. These researchers received intensive training on the assessment measures and had supervision sessions with a senior researcher during data collection.
PSYCHOPATHY.COMP's therapists were three psychologists, who had at least six years of clinical experience as well as intensive training and experience in delivering the PSYCHOPATHY.COMP program to young offenders. Moreover, therapists received weekly supervision by a senior CFT expert during the time PSYCHOPATHY.COMP was run in juvenile detention facilities. Therapist and youth rated every session and 5% of the sessions were observed by independent raters in order to assess treatment integrity. Finally, the program's structured and manualized design also accounted for integrity, at least partially.
101 studies on the registry are indexed under Conduct Disorder; 15 are open to participants now.
This study's enrollment of 150 is above the median of 124 across 80 interventional studies indexed under Conduct Disorder.
Browse Conduct Disorder studies →University of Coimbra is the lead sponsor of 87 studies on the registry; 25 are open to participants now.
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The PSYCHOPATHY.COMP is a structured individual program for detained youth. This program is based on Compassion Focused Therapy (CFT), which conceptualizes antisocial behavior and psychopathic traits as evolutionary rooted responses to deal with harsh rearing scenarios. The ultimate goal of the PSYCHOPATHY.COMP is to develop a compassionate motivation in these youth. PSYCHOPATHY.COMP consists of 20 individual sessions, each lasting about 60 minutes, which run on a weekly basis. Sessions must be carried out by therapists skillful in CFT. Sessions are grouped into four modules: (1) The basics of our mind; (2) Our mind according to CFT; (3) Compassionate Mind Training; and (4) Recovery, relapse prevention, and finalization. The treatment group attended the PSYCHOPATHY.COMP program in addition to the Treatment As Usual (TAU) delivered at Portuguese juvenile detention facilities.
Behavioral: PSYCHOPATHY.COMP program. · Other: Treatment As Usual - TAU
Treatment As Usual: Subjects in this group received Treatment As Usual in Portuguese juvenile detention facilities (school frequency, token economy system for behavior control, frequency of a structured cognitive-behavioral group program, as well as individualized counseling sessions delivered by psychologists from the juvenile justice system) and did not attend the PSYCHOPATHY.COMP program.
Other: Treatment As Usual - TAU
The PSYCHOPATHY.COMP program is a structured individualized program for detained youth based on Compassion Focused Therapy, aimed to develop a compassionate motivation in these youth. Treatment As Usual Treatment As Usual (TAU) in Portuguese juvenile detention facilities is primarily aimed to increase educational and professional qualifications, as well as to promote behavioral regulation.
Treatment As Usual (TAU) in Portuguese juvenile detention facilities is primarily aimed to increase educational and professional qualifications, as well as to promote behavioral regulation.
Change of psychopathic traits
Participants reported on the Youth Psychopathic Traits Inventory-Short (YPI-S; Van Baardewijk et al. 2010). The YPI-S is an 18-item self-report questionnaire, which assesses psychopathic traits in youth via ratings within three different factors: Grandiose-Manipulative (GM); Callous-Unemotional (CU), and Impulsive-Irresponsible (II). Each factor is estimated by a set of six items; each item is rated on a four-point scale (1 = "Does not apply at all" to 4 = "Applies very well").This assessment was carried out by researchers, who received training in this self-report measures.
Time frame: baseline; 6 months, 12 months
Change psychopathic traits
Participants reported on the Proposed Specifiers for Conduct Disorder (PSCD; Salekin \& Hare, 2016). The PSCD is a 24-item self-report questionnaire, which assesses the above mentioned psychopathic traits, as well as antisocial behavior. Each factor is estimated by a set of six items; each item is rated on a three-point scale (0 = "False" to 2 = "True"). This assessment was carried out by researchers, who received training in this self-report measures.
Time frame: baseline; 6 months, 12 months
External Shame
Participants reported on a questionnaire of external shame, the Other as Shamer Scale Brief-Adolescent version (OASB-A; Vagos et al., 2016b). The OASB-A is an 8-item self-report scale that measures external shame, i.e., a subject's perception of being negatively judged by others. Items are rated on a five-point frequency scale (0= "Never"; 4-"Almost Always"), reporting how frequently one experiences the feelings described in each statement. This assessment was carried out by researchers, who received training in the self-report measure.
Time frame: baseline; 6 months, 12 months
Social Safeness and Pleasure
Participants reported on a questionnaire of social safeness and pleasure, the Social Safeness and Pleasure Scale (SSPS; Cook, 1996). The SSPS is an 11-item self-report scale that measures social safeness, i.e., the extent to which individuals feel a sense of acceptance and connectedness in their social relationships. Items are rated on a 5-point scale (1 = "Almost never" to 5 = "Almost all the time"). This assessment was carried out by researchers, who received training in the self-report measure.
Time frame: baseline; 6 months, 12 months
Self-Compassion
Participants reported on a questionnaire of self-compassion, the Self-Compassion Scale (SCS; Neff 2003a). The SCS is a 26-item self-report scale, which assesses trait levels of self-compassion. It includes items that measure how often people respond to feelings of inadequacy or suffering with self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Responses are given on a 5-point scale from (1 = "Almost Never" to 5 = "Almost Always"). This assessment was carried out by researchers, who received training in the self-report measure.
Time frame: baseline; 6 months, 12 months
Compassion
Participants reported on a questionnaire of compassion, the Compassion Scale (CS; Pommier, 2011). The CS is a 24-item self-report questionnaire that measures compassion for others, and it is composed by six subscales: Kindness; Common Humanity; Mindfulness; Indifference; Separation, and Disengagement. Participants rate each item according to how frequently they feel and act towards others, using a five-point scale (1 = "Almost Never" to 5 = "Almost Always"). This assessment was carried out by researchers, who received training in the self-report measure.
Time frame: baseline; 6 months, 12 months
Fears of Compassion
Participants reported on a questionnaire of fears of compassion, the Fears of Compassion Scale (FCS; Gilbert, McEwan, Matos, \& Rivis, 2011). The FCS is a three-section measure that assesses fears related to giving and receiving compassion and fears of self-compassion. Items are rated on a 5-point scale (0 = "Totally disagree" to 4 = "Totally Agree"). This assessment was carried out by researchers, who received training in the self-report measure.
Time frame: baseline; 6 months, 12 months
Emotion Regulation
Participants reported on a questionnaire of emotion regulation, the Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004). The DERS is a 36-item self-report measure that assesses individuals' typical levels of emotion dysregulation across six separate domains: non-acceptance of negative emotions, inability to engage in goal-directed behaviors when experiencing negative emotions, difficulties controlling impulsive behaviors when experiencing negative emotions, limited access to emotion regulation strategies perceived as effective, lack of emotional awareness, and lack of emotional clarity. Items are scored on a 5-point scale (1 = "Almost never" to 5 = "Almost Always"). This assessment was carried out by researchers, who received training in the self-report measure.
Time frame: baseline; 6 months, 12 months
Heart Rate/Heart Rate Variability
Psychophysiological measures of HR/HRV of the participants were collected throughout an experimental procedure designed in accordance to the conceptual model of Compassion Focused Therapy. This assessment was carried out by researchers, who received specific training.
Time frame: baseline; 6 months, 12 months
Disruptive Behavior
To assess behavior regulation during the research period, a grid was developed to collect the following data from participants' record files: number of disciplinary infractions and number of days in punishment.
Time frame: from baseline to 6 months' follow-up
Psychopathology
Participants were interviewed with the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID; Sheehan et al., 2010). The MINI-KID is a structured clinical diagnostic interview, which assesses DSM disorders in children and adolescents. This assessment was carried out by researchers who had special training in the diagnosis of psychopathological disorders and previous experience administering the MINI-KID interview.
Time frame: Baseline
Recidivism Risk Assessment
Recidivism risk was assessed through the Youth Level of Service/Case Management Inventory (YLS/CMI; Hoge, Andrews, \& Leschied, 2002). This assessment was completed by a probation officer. The YLS/CMI is a 42-item checklist, which assesses eight different risk factors/needs: Prior and Current Offenses/Disposition, Family Circumstances/Parenting, Education/Employment, Peer Relations, Substance Abuse, Leisure/Recreation, Personality/Behavior, and Attitudes/Orientation. Each item is scored dichotomously (present/absent). Each response in the affirmative receives a point towards the respective factor score and also to the total score (i.e., the sum of all eight risk/need scores). In this trial, the total risk score of the YLS/CMI was used as a measure of recidivism risk. Based on the total score, youth can be categorized into four levels of recidivism risk: low (0-8 points), moderate (9-22 points), high (23-34 points), or very high (35-42 points).
Time frame: Baseline
Ran from Mar 2018 to primary completion in Mar 2020, 24 months.
Of 29 interventional studies with no phase under Conduct Disorder, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's 24 months is below that.
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University of Coimbra