The Efficacy of a Compassion Focused Therapy-based Intervention in Detained Youth

NCT ID: NCT03971682

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-03-31

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.

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.

Conditions

Psychopathic Personality Trait; Conduct Disorder; Delinquency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental - PSYCHOPATHY.COMP program.

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.

Group Type: EXPERIMENTAL

PSYCHOPATHY.COMP program.

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Treatment As Usual - TAU

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment As Usual - TAU

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Diana Ribeiro da Silva

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Rijo, PhD

Role: PRINCIPAL_INVESTIGATOR

CINEICC

Locations

Faculty of Psychology and Educational Sciencies, University of Coimbra

Coimbra, , Portugal

Countries

Portugal

References

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.

Reference Type: DERIVED

PMID: 36704737 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35901377 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34264698 (View on PubMed)

Other Identifiers

SFRH/BD/99795/2014

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

POCI-01-0145-FEDER-016724

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CINEICC-1-DRS

Identifier Type: -

Identifier Source: org_study_id