Clinical trial NCT06191653: Mindfulness and Self-Compassion With Caregivers Working With Delinquent Youth
Official title: The Efficacy of a Mindful Self-compassion Based Program With Caregivers of Young Offenders Placed at the Portuguese Juvenile Justice Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers of Delinquent Youth
Keywords: Caregivers
Clinical Trial
Delinquent youth
Mindful Self-Compassion
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Foundation for Science and Technology, Portugal
First posted: 2024-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This project will use a longitudinal design. Caregivers recruited from 4 (out of 6) YDC, selected based the number of available caregivers, were allocated to two conditions: 2 to the treatment group and the other 2 to the wait-list control group. The criteria of this allocation was the number of caregivers available in each institution: the treatment group was composed of the two YDC with the larger number of caregivers in order to increase the chance of having a greater number of participants and dealing with natural dropout levels. A sample of youth was all recruited in all 4 YDC to assess the indirect impact of the intervention program. This trial included a Treatment group (N=34), a Waiting list Control group (N=36), and a sample of youth (45 recruited from the Treatment YDC and 31 recruited from the Control YDC).
Primary purpose: TREATMENT

Brief summary: The work carried out in Youth Detention Centers (YDC) represents a set of challenges for caregivers, who are in the frontline of juvenile delinquency. These professionals have daily to cope daily with work and relational challenges, while experiencing high levels of stress and physical and emotional fatigue. As such, taking care of the well-being of these professionals is of paramount importance, moreso as they are fundamental in the rehabilitation of young offenders. Still, the usual training/interventions offered to these professionals does not consider/fit to their psychological, emotional, or psychical difficulties. Recent studies have explored the impact of contextual cognitive-behavioral interventions with caregivers (e.g., parents of individuals with developmental disabilities, nurses, healthcare providers), namely those based on Mindfulness and Self-Compassion. The Mindfulness Self-Compassion Program (MSC) has been found to be effective in reducing caregivers' overwhelmed feelings about their own suffering and/or the suffering of others.

This clinical trial intends to explore the adequacy of the adapted form of MSC (12 group sessions) to caregivers working in YDC, and to establish its effectiveness. Two main studies will be carried out: 1) a parallel non-randomized clinical trial, in which the effectiveness of the program will be explored, as well as the mechanisms of change of the participants' responsiveness to the intervention; and 2) individual interviews to assess qualitatively the participants' perception about the usefulness and impact of the intervention (concerning their relationship with youth and with work colleagues, their relationship with themselves and the general climate of the YDC). A sample of youth placed in each selected YDC will be recruited and will be assessed through self-report questionnaires at the same moments as caregivers samples. It is hypothesized that the adapted form of MSC will produce significant improvements in outcome measures when comparing caregivers who receive the intervention program with those in the control group. Specifically, it is expected an improvement in caregivers' positive feelings and well-being, in their sensitivity and compassion towards others' suffering, as well as a decrease on some indicators of stress and suffering. Consequently, it is also expected that youth in YDC perceive more warmth and safeness experiences with caregivers and report increases in their interpersonal functioning.

Detailed description: Youth delinquency is a relevant social problem and there is growing interest in improving intervention with young offenders. Interventions developed at the Youth Detention Centers (YDC) involve several human resources, who daily supervise the youth routines, care for them, and model their behaviors. The challenges and difficulties of working with people with delinquent behavior have been explored in different groups of caregivers, but little studied in caregivers of young offenders. Such difficulties are identified as risk factors for the development of physical and psychological symptoms in caregivers, and seem to be related to personal issues (e.g., gender, age, education level, personal beliefs, work-related motivations and levels of perceived social support), but also with issues inherent to the work context, characterized as challenging, demanding and of great responsibility (e.g., the ambiguity of professional role, time spent in a corrective context, supervision, and support from hierarchical superiors, job satisfaction, and commitment. Some authors argue that the constraints placed on caregivers significantly predict high levels of stress and compassion fatigue/burnout manifested by symptoms of depression, anxiety, and physical/psychological exhaustion, with a negative impact on levels of compassion for others, on the performance of professional duties and on the satisfaction of those who are cared for. As a result of these difficulties, self-care practices have been recommended in order to prevent and/or relieve these symptoms in caregivers. Still, also in Portugal, tutelary/educative interventions are predominant, with efforts being focused on the psychological rehabilitation of delinquent youth and disregarding those responsible for that rehabilitation.

Recent research has evaluated the impact of contextual cognitive-behavioral interventions with groups of caregivers. Interventions based on Mindfulness, which aims to promote non-reactive awareness of thoughts, emotions, and bodily sensations, and those that promote Self-compassion have stood out for their effectiveness. In particular, the Mindful Self-Compassion Program (MSC) encompasses the two previously described components and, despite being less studied than approaches based solely on Mindfulness, has gathered effectiveness evidence with various groups of caregivers (e.g., nurses, healthcare providers) and on skills considered essential for caregivers to respond to the needs of those they care (e.g., reduction of physical/psychological problems; increases quality/satisfaction with life and levels of empathy and compassion towards others. Recent research has shown that the MSC seems to be effective in reducing the caregiver's feeling of burden with their own suffering and/or with the suffering of others.

Despite the importance of establishing positive and safe relationships between young offenders and their caregivers, studies carried out with caregivers are scarce and focus mainly on assessing their needs and/or difficulties, not aiming to intervene on them. Interventions offered to these caregivers aim to train them to deal with youth behavioral problems, to improve their knowledge on delinquent developmental trajectories, or to improve the physical/relational settings of caregiving contexts.

This work aims to fulfill this gap, by studying the effectiveness of an adapted form of MSC in promoting self-care and satisfaction with life and work, which are considered essential for effective care provision, in caregivers of young people in Portuguese YDC. This clinical trial is a parallel non-randomized controlled trial, designed according to the CONSORT guidelines, and carried out in 4 (out of 6) YDC. It aimed to test the efficacy of an adapted form of the MSC applied to caregivers working on YDC. It is expected that the application of the adapted form of MSC to the YDC caregivers will contribute to an increase in caregivers' physical, emotional, and psychological well-being and job satisfaction. In addition, it is also expected that the improvements mentioned above have a positive impact on the quality of the provided care and the interpersonal functioning of delinquent youth.

All procedures involved in this project (described elsewhere in this form) were carried out according to the ethical principles of the Declaration of Helsinki and the applicable national laws and regulations. Moreover, all procedures were approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences, University of Coimbra as well as by the Portuguese Juvenile Ministry of Justice.

Informed consent will be required for all potential participants prior to any data collection. Caregivers will give informed consent. Adolescents aged between 14 and 16 years old (YO), will give informed assent, while those older than 16 YO will give written informed consent. A written informed consent will be gathered from guardians/legal representatives of all adolescent participants under 18 YO. All participants (i.e., caregivers and adolescents, as well as their parents/legal guardians) will be informed that their participation is voluntary and that they could decline to participate at any time during the project without any negative consequence. Moreover, participants will be informed that the confidentiality of responses would be assured at all moments. The anonymity of all participants' responses is guaranteed, with the use of respondent-specific codes, which will be also used to link the data from one time point to the other.

From the 6 Portuguese YDC, 4 will be selected considering the number of caregivers. YDC with the highest number of staff will be selected for participation. Two YDC will be allocated to the Treatment Group (TG) and the other two to the Control Group (CG); one treatment and one control group will be considered during the year of execution of this research, and the other treatment and control groups will be sequentially considered in the following year after all procedures with the first groups were concluded.

Caregivers in the TG will attend the adapted form of MSC for about 12 weeks. The intervention consists of 12 two-hour weekly group sessions (including a 10-minute coffee break), delivered in each YDC to a group of 4 to 8 participants. The hours spent participating in the project (24 hours) will be given as time off. Caregivers in the CG, which functions as a waiting list control group, did not receive any intervention during the study. It is intended that those caregivers receive the intervention after the end of all assessment moments and at a time to be agreed with the Portuguese Juvenile Ministry of Justice. Adolescents cared both by workers in the TG and CG will not receive any intervention during the study. Treatment integrity will be ensured through: a) specific treatment manuals; b) direct training of the therapist and c) supervision by a senior therapist, with advanced training on the MSC program.

Caregivers of both groups will fill out the assessment protocol individually during working hours in each YDC and the adolescents of both groups will complete the self-report questionnaires, individually, in the presence of the researcher responsible for the project. All participants (caregivers and adolescents) will be assessed through self-report measures 4 times across 12 months. Specifically, participants will be assessed before the first session of the program (baseline - time 1), right after its terminus (i.e., post-treatment assessment - time 2), and 3 and 6 months after intervention terminus (follow-up 1 and 2 - time 3 and time 4). Participants in the control group (both youth and caregivers) will be assessed using the same self-report instruments and with the same time intervals as those in the intervention group. Quantitative analyses will be carried out according to the principle of Intention-to-treat analysis (including all participants regardless of whether or not they participated in all sessions). Analyses will also be carried out only with participants who completed the protocol (Peer-protocol analysis). Treatment effects and covariate effects will be analysed with mixed MANOVAs. Change mechanism studies will be analysed with two-wave latent growth curve models.

On 3 and 6-months follow-up assessments, in addition to the assessment protocol, caregivers of the TG will also be qualitatively evaluated, through individual interviews. The participants will be asked about their perception of the impact of participating in the MSC program on their relationships at the YDC (namely with youth and with colleagues), their perception of institutional climate, their relationship with themselves, and difficulties they might have felt during on using the strategies and contents learned on the MSC program. This data will be analysed through thematic, content, and discourse analysis.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for caregivers:

Professionals working in YDC for at least 6 months Professionals that directly interacte with the delinquent youth on a regular basis (minimum of 30/hours per week).

* Inclusion criteria for youth:

Youth that entered the YDC at least 3 months before the study's onset (adjustment time); Aged between 14 and 18 YO; Know how to read/write and Portuguese language.

Exclusion Criteria:

- Exclusion criteria for youth: Cognitive impairment or diagnosis of a psychotic disorder; Remaining in YDC for less than 9 months.

-

Primary outcomes:
measure: The Self-Compassion Scale (SCS)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: Compassion Scale (CS)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: Fears of Compassion Scale (FCS)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: Cognitive and Affective Mindfulness Scale - Revised Form (CAMS-R)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
Secondary outcomes:
measure: Professional Quality of Life Scale - version 5 (ProQOL-5)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: Depression, Anxiety, and Stress Scale - 21 (DASS-21)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: The Caring Shame and Guilt Scale (CSGS)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: Social Connectedness Scale - Revised Form (SCS-R)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: General Work-Related Stress Questionnaire (QSo-G)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: OSQ (Ocupational satisfaction questionnaire)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: World Health Organization Quality of Life-Brief (WHOQOL-BRIEF)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: Current Warmth and Safeness experiences (CEWSS-A)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: Social Connectedness Scale - Revised Adolescents Form (SCS-RA)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: Other as Shamer - Brief Form for adolescents (OAS-BA)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: Self-Compassion Scale - Adolescent version (SCS-A)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: KIDSSCREEN-27
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
measure: Proposed Specifiers for Conduct Disorder (PSCD)
timeFrame: Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months
Other outcomes:
measure: Individual interviews for assessing qualitatively the perception of the impact of the MSC program
timeFrame: Follow-Up 3 Months and Follow-Up 6 Months
Locations:
city: Coimbra
country: Portugal
facility: Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra
Study officials:
affiliation: Faculty of Psychology and Educational Sciences - University of Coimbra.
name: Marlene M Paulo, Master
role: PRINCIPAL_INVESTIGATOR
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