Clinical trial NCT03971682: The Efficacy of a Compassion Focused Therapy-based Intervention in Detained Youth
Official title: The Efficacy of a Compassion Focused Therapy-based Intervention in Detained Youth: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychopathic Personality Trait
Conduct Disorder
Delinquency
Keywords: Conduct Disorder
Compassion Focused Therapy
Detained Youth
Psychopathic Traits
PSYCHOPATHY.COMP
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 150
Sex: MALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change of psychopathic traits
timeFrame: baseline; 6 months, 12 months
measure: Change psychopathic traits
timeFrame: baseline; 6 months, 12 months
Secondary outcomes:
measure: External Shame
timeFrame: baseline; 6 months, 12 months
measure: Social Safeness and Pleasure
timeFrame: baseline; 6 months, 12 months
measure: Self-Compassion
timeFrame: baseline; 6 months, 12 months
measure: Compassion
timeFrame: baseline; 6 months, 12 months
measure: Fears of Compassion
timeFrame: baseline; 6 months, 12 months
measure: Emotion Regulation
timeFrame: baseline; 6 months, 12 months
measure: Heart Rate/Heart Rate Variability
timeFrame: baseline; 6 months, 12 months
measure: Disruptive Behavior
timeFrame: from baseline to 6 months' follow-up
Other outcomes:
measure: Psychopathology
timeFrame: Baseline
measure: Recidivism Risk Assessment
timeFrame: Baseline
Locations:
city: Coimbra
country: Portugal
facility: Faculty of Psychology and Educational Sciencies, University of Coimbra
Study officials:
affiliation: CINEICC
name: Daniel Rijo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.