NCT03971682

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

May 29, 2019

Last Update Submit

April 26, 2021

Conditions

Keywords

Conduct DisorderCompassion Focused TherapyDetained YouthPsychopathic TraitsPSYCHOPATHY.COMP

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    baseline; 6 months, 12 months

Secondary Outcomes (8)

  • External Shame

    baseline; 6 months, 12 months

  • Social Safeness and Pleasure

    baseline; 6 months, 12 months

  • Self-Compassion

    baseline; 6 months, 12 months

  • Compassion

    baseline; 6 months, 12 months

  • Fears of Compassion

    baseline; 6 months, 12 months

  • +3 more secondary outcomes

Other Outcomes (2)

  • Psychopathology

    Baseline

  • Recidivism Risk Assessment

    Baseline

Study Arms (2)

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.

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.

Other: Treatment As Usual - TAU

Interventions

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.

Experimental - PSYCHOPATHY.COMP program.

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.

Experimental - PSYCHOPATHY.COMP program.Treatment As Usual - TAU

Eligibility Criteria

Age14 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Detained youth aged between 14 and 18 years old
  • Presence of Conduct Disorder as the main diagnosis (MINI-KID)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology and Educational Sciencies, University of Coimbra

Coimbra, 3001-802, Portugal

Location

Related Publications (3)

  • 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.

  • Rijo 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.

  • Ribeiro 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.

MeSH Terms

Conditions

Conduct Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Daniel Rijo, PhD

    CINEICC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 3, 2019

Study Start

March 1, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 27, 2021

Record last verified: 2021-04

Locations