Psychopathic Personality TraitPSYCOMPNCT03971682
The Efficacy of a Compassion Focused Therapy-based Intervention in Detained Youth
A study testing PSYCHOPATHY.COMP program. and Treatment As Usual - TAU in people with Psychopathic Personality Trait and Conduct Disorder, run by University of Coimbra at 1 site in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psychopathic Personality Trait, Conduct Disorder, Delinquency
- What is being tested?
- PSYCHOPATHY.COMP program. and Treatment As Usual - TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2018to 31 Mar 2020
- 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 14 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Detained youth aged between 14 and 18 years old
- Presence of Conduct Disorder as the main diagnosis (MINI-KID)
Who cannot join
- Non-Portuguese speaking (to avoid communication issues);
- Remaining in the juvenile detention facility less than 12 months since the beginning of the program (taking into account PSYCHOPATHY.COMP length and assessment period)
- Presence of cognitive disabilities (because PSYCHOPATHY.COMP is not suitable for cognitively-impaired youth)
- Presence of psychotic symptoms (the experiential exercises used in the program are contraindicated for psychotic patients)
- Presence of autism spectrum disorders (because PSYCHOPATHY.COMP was not designed considering the social impairments of these youth).
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculty of Psychology and Educational Sciencies, University of Coimbra
Coimbra, 3001-802
About this study
Official title: The Efficacy of a Compassion Focused Therapy-based Intervention in Detained Youth: A Clinical Trial
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.
Read the detailed description
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.
- Being tested
- PSYCHOPATHY.COMP program., Treatment As Usual - TAU
- Keywords
- Conduct Disorder, Compassion Focused Therapy, Detained Youth, Psychopathic Traits, PSYCHOPATHY.COMP
- Medical subject headings
- Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSYCHOPATHY.COMP program.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - PSYCHOPATHY.COMP program. | Experimental | 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. Receives: Behavioral: PSYCHOPATHY.COMP program.; Other: Treatment As Usual - TAU |
| Treatment As Usual - TAU | Active comparator | 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. Receives: Other: Treatment As Usual - TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline; 6 months, 12 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from baseline to 6 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 posted3 Jun 2019
- Study start1 Mar 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
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 Psychopathic Personality TraitStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Ribeiro da Silva, University of Coimbra
- Investigators
- Daniel Rijo, PhD, Principal investigator, CINEICC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971682
- Sponsor's protocol ID
- CINEICC-1-DRS
- Other IDs
- SFRH/BD/99795/2014, POCI-01-0145-FEDER-016724
- Acronym
- PSYCOMP
- Status last verified
- Apr 2021
- First submitted
- 29 May 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sousa R, Ribeiro da Silva D, Petrocchi N, Gilbert P, Rijo D. At the heart of change: Differences in young offenders' HRV patterns after the delivery of the PSYCHOPATHY.COMP program. Front Psychiatry. 2023 Jan 10;13:1032011. doi: 10.3389/fpsyt.2022.1032011. eCollection 2022.
PubMed 36704737Rijo D, Ribeiro da Silva D, Brazao N, Paulo M, Ramos Miguel R, Castilho P, Vagos P, Gilbert P. Promoting a compassionate motivation in detained youth: A secondary analysis of a controlled trial with the PSYCHOPATHY.COMP program. Personal Disord. 2023 Mar;14(2):223-236. doi: 10.1037/per0000594. Epub 2022 Jul 28.
PubMed 35901377Ribeiro da Silva D, Rijo D, Brazao N, Paulo M, Miguel R, Castilho P, Vagos P, Gilbert P, Salekin RT. The efficacy of the PSYCHOPATHY.COMP program in reducing psychopathic traits: A controlled trial with male detained youth. J Consult Clin Psychol. 2021 Jun;89(6):499-513. doi: 10.1037/ccp0000659.
PubMed 34264698
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Compassion Focused Therapy-based Intervention in Detained Youth: A Clinical Trial
- ClinicalTrials.gov ID
- NCT03971682
- Acronym / sponsor ID
- PSYCOMP / CINEICC-1-DRS
- Keywords
- Conduct Disorder, Compassion Focused Therapy, Detained Youth, Psychopathic Traits, PSYCHOPATHY.COMP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 3 Jun 2019 (actual)
- 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - PSYCHOPATHY.COMP program. | Experimental | Behavioral: PSYCHOPATHY.COMP program., Other: Treatment As Usual - TAUThe 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. |
| Treatment As Usual - TAU | Active comparator | Other: Treatment As Usual - TAUTreatment 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Detained youth aged between 14 and 18 years old
- Presence of Conduct Disorder as the main diagnosis (MINI-KID)
Key exclusion criteria (5 listed)
- Non-Portuguese speaking (to avoid communication issues);
- Remaining in the juvenile detention facility less than 12 months since the beginning of the program (taking into account PSYCHOPATHY.COMP length and assessment period)
- Presence of cognitive disabilities (because PSYCHOPATHY.COMP is not suitable for cognitively-impaired youth)
- Presence of psychotic symptoms (the experiential exercises used in the program are contraindicated for psychotic patients)
- Presence of autism spectrum disorders (because PSYCHOPATHY.COMP was not designed considering the social impairments of these youth).
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 |
|---|---|---|
| PSYCHOPATHY.COMP program.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. | Behavioural | Experimental - PSYCHOPATHY.COMP program. |
| Treatment As Usual - TAUTreatment As Usual (TAU) in Portuguese juvenile detention facilities is primarily aimed to increase educational and professional qualifications, as well as to promote behavioral regulation. | Other | Experimental - PSYCHOPATHY.COMP program., Treatment As Usual - TAU |
Primary outcome
Change of psychopathic traits
Time frame: baseline; 6 months, 12 months
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.
Change psychopathic traits
Time frame: baseline; 6 months, 12 months
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.
8 secondary outcomes
External Shame
Time frame: baseline; 6 months, 12 months
Social Safeness and Pleasure
Time frame: baseline; 6 months, 12 months
Self-Compassion
Time frame: baseline; 6 months, 12 months
Compassion
Time frame: baseline; 6 months, 12 months
Fears of Compassion
Time frame: baseline; 6 months, 12 months
Emotion Regulation
Time frame: baseline; 6 months, 12 months
Heart Rate/Heart Rate Variability
Time frame: baseline; 6 months, 12 months
Disruptive Behavior
Time frame: from baseline to 6 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 27 Apr 2021.
- Derived from this study: PubMed 36704737Sousa R, Ribeiro da Silva D, Petrocchi N, Gilbert P, Rijo D. At the heart of change: Differences in young offenders' HRV patterns after the delivery of the PSYCHOPATHY.COMP program. Front Psychiatry. 2023 Jan 10;13:1032011. doi: 10.3389/fpsyt.2022.1032011. eCollection 2022.
- Derived from this study: PubMed 35901377Rijo D, Ribeiro da Silva D, Brazao N, Paulo M, Ramos Miguel R, Castilho P, Vagos P, Gilbert P. Promoting a compassionate motivation in detained youth: A secondary analysis of a controlled trial with the PSYCHOPATHY.COMP program. Personal Disord. 2023 Mar;14(2):223-236. doi: 10.1037/per0000594. Epub 2022 Jul 28.
- Derived from this study: PubMed 34264698Ribeiro da Silva D, Rijo D, Brazao N, Paulo M, Miguel R, Castilho P, Vagos P, Gilbert P, Salekin RT. The efficacy of the PSYCHOPATHY.COMP program in reducing psychopathic traits: A controlled trial with male detained youth. J Consult Clin Psychol. 2021 Jun;89(6):499-513. doi: 10.1037/ccp0000659.
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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.
Daniel Rijo, PhD principal investigator
CINEICC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSYCHOPATHY.COMP program. and Treatment As Usual - TAU in people with Psychopathic Personality Trait and Conduct Disorder, run by University of Coimbra at 1 site in Portugal.
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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change of psychopathic traits (time frame: baseline; 6 months, 12 months). 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 NCT03971682, 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 27 Apr 2021.