NCT06191653

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2024

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

December 19, 2023

Last Update Submit

March 17, 2025

Conditions

Keywords

CaregiversClinical TrialDelinquent youthMindful Self-Compassion

Outcome Measures

Primary Outcomes (4)

  • The Self-Compassion Scale (SCS)

    The SCS (original version (OV) Neff, 2003; Portuguese version (PV) Castilho \& Pinto-Gouveia, 2012) consists of a 26-item scale that intends to assess levels of self-compassion. It is composed of six factors, threebeing positive (i.e., Self-kindness, Common humanity, and Mindfulness) and three being and focusing on a lack of self-compassion (i.e., Self-judgment, Isolation, and Over-identification). Items are rated on a 5-point Likert scale (1 - almost never to 5 - almost always). Previous research on SCS has shown good psychometric properties (Castilho \& Pinto-Gouveia, 2012; Neff, 2003).

    Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months

  • Compassion Scale (CS)

    The CS (OV: Pommier, 2011; PV: Sousa et al., 2017) is a 24-item self-report questionnaire that measures compassion towards others and is composed of six subscales: Kindness; Common Humanity; Mindfulness; Indifference; Separation, and Disengagement. Items are rated using a five-point Likert scale (from 1 = almost never to 5 = almost always) according to how frequently participants feel and act towards others. Previous psychometric information showed good internal consistency values (Pommier, 2011; Sousa et al., 2017).

    Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months

  • Fears of Compassion Scale (FCS)

    The FCS (OV: Gilbert et al. 2011; PV: Simões, 2012) is a 38-item scale that comprises three subscales measuring: Fears of expressing compassion for others (composed of 10 items, 9 in the Portuguese version); Fears of receiving compassion from others; and Fears of expressing self-compassion (assessed for 15 items). The items are rated on a five-point Likert scale (0 = Do not agree at all to 4 = Completely agree). Previous psychometric studies reported very good internal consistency levels (Gilbert et al., 2011; Simões, 2012).

    Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months

  • Cognitive and Affective Mindfulness Scale - Revised Form (CAMS-R)

    The CAMS-R (OV: Feldman et al., 2007; PV: Teixeira \& Pereira, 2015) consists of 12 itens intending to the degree to which individuals experience their thoughts and feelings and does not require meditation training. Items are answered on a 4-point Likert scale from 1 (not at all) to 4 (almost always). Previous research on CAMS-R reported acceptable to good internal consistency values (Feldman et al., 2007; Teixeira \& Pereira, 2015).

    Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months

Secondary Outcomes (13)

  • Professional Quality of Life Scale - version 5 (ProQOL-5)

    Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months

  • Depression, Anxiety, and Stress Scale - 21 (DASS-21)

    Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months

  • The Caring Shame and Guilt Scale (CSGS)

    Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months

  • Social Connectedness Scale - Revised Form (SCS-R)

    Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months

  • General Work-Related Stress Questionnaire (QSo-G)

    Baseline, Week 13, Follow-Up 3 Months and Follow-Up 6 Months

  • +8 more secondary outcomes

Other Outcomes (1)

  • Individual interviews for assessing qualitatively the perception of the impact of the MSC program

    Follow-Up 3 Months and Follow-Up 6 Months

Study Arms (2)

Treatment group

EXPERIMENTAL

The adapted form of the MSC, composed for 12 sessions, will be delivered on a weekly basis in group. This intervention program intends to cultivate a compassionate-self as well as increase the awareness of personal patterns of functioning and learning to respond to them in a kind, courageous, and fierce way. All the sessions will be delivered in a space on each YDC.

Behavioral: Mindfulness and Self-Compassion for Caregivers working in Youth Detention Centres

Control Group

NO INTERVENTION

This group, wich will be a waiting list control goup, will not receive any mind training or group intervention during the study. Participants of this group will be assessed at 4 different time points (pre- and post-treatment and at a 3- and 6-month follow-up). After all assessment moments are completed, the intervention program will be delivered with the caregivers of this group. These caregivers will 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 wokers in the TG and CG will not receive any intervention during the study.

Interventions

The adapted form of the MSC is a 12-session structured program, delivered on a weekly basis in group. It intends to cultivate a compassionate-self as well as increase the awareness of personal patterns of functioning and learning to respond to them in a kind and courageous way. Each session lasts about 2 hours. Each session has the following structure: Grounding exercise; sharing individual insights about the weekly practice; Reviewing the previous session and link for the session theme; coffee break; soft landing exercise; Formal/Informal practice(s); Session summary and challenges to be applied during the week; Session evaluation and take-off. Each participant receives a manual with the contents shared in each session as well as some space for individual reflections. On the day after each session, a summary email is sent to the participants, resuming the contents and with records of the (in)formal practices delivered. All the sessions will be delivered in a space on each YDC.

Treatment group

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra

Coimbra, 3000-375, Portugal

Location

Related Publications (52)

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MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marlene M Paulo, Master

    Faculty of Psychology and Educational Sciences - University of Coimbra.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This project will use a longitudinal design. Caregivers recruited from 4 (out of 6) YDC, selected based the number of available caregivers, will be allocated to two conditions: 2 to the treatment group and the other 2 to the wait-list control group. The criteria of this allocation is the number of caregivers available in each institution: the treatment group will be 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 will be recruited in all 4 YDC to assess the indirect impact of the intervention program. This trial will include a Treatment group (N=25), a Waiting list Control group (N=25), and a sample of youth (20 recruited from the Treatment YDC and 20 recruited from the Control YDC).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

September 15, 2022

Primary Completion

October 30, 2022

Study Completion

March 28, 2024

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations