The Efficacy of a Compassionate Mind Training Program With Caregivers of Residential Youth Care

NCT ID: NCT04512092

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-01-30

Brief Summary

This clinical trial aims to improve the quality of the care provided in residential youth care, through a Compassionate Mind Training (CMT-C) program targeted to caregivers. The promotion of an affiliative mentality of caring, warmth and affection in the residential care setting is operationalized through the development of a compassionate-self and compassionate care skills. A cluster randomized trial with a control group was carried out in order to test the efficacy of a 12-session Compassionate Mind Training Program to caregivers of residential youth care in increasing compassion, self-compassion, social safeness, emotional climate, empathy, emotion regulation, satisfaction with life, and resiliency and in reducing self-criticism, fears of compassion as well as stress, burnout, anxiety and depression. Youths in residential care were also assessed as informants, thought self-reported questionnaires on current experiences of warmth and safeness, social safeness, emotional climate, positive and negative affect. The organizational impact was assessed via focus groups. It is hypothesized that the CMT-C would produce significant improvements in outcome measures, when comparing caregivers who receive the CMT-C with those in the control group. It is expected that after the training, caregivers will present a greater sensibility to their own and others suffering and motivation to relieve it, exhibiting and experiencing empathic responses. Consequently, it is also expected that youths in care perceive more warmth and safeness experiences with caregivers and a more secure and safe emotional climate in the residential care home.

Detailed Description

This was a Cluster Randomized Trial with a control group carried out in twelve Portuguese Residential Youth Care facilities. It aimed to test the efficacy of a group-based Compassionate Mind Training program (CMT-C) targeted to caregivers, in promoting significant changes both in caregivers and adolescents in residential youth care. This trial was carried out in accordance with the ethical principles of the Declaration of Helsinki and the applicable national laws and regulations. The ethics committee of the Faculty of Psychology and Educational Sciences of the University of Coimbra approved the study's procedures.

Since CMT-C is targeted for residential care homes' (RCH) teams, for practical reasons (to maximize time and human resources) and to avoid contamination, the unit of randomization was the RCH (i.e., cluster), hence a cluster randomized design was followed according CONSORT guidelines. From the 32 RCH within the Centre region of Portugal, 19 RCH obeying to cluster eligibility criteria were invited to participate. Twelve RCH agreed to enter the trial. Their caregivers and adolescents, who were eligible for the study, were informed of the goals and procedures of this research, and invited to voluntarily participate. No incentives were offered for participation. Written informed consent were sought at the cluster level (from the board of each RCH), and at the individual level to caregivers and adolescents (and their legal guardians), before the randomization occurred. Adolescents aged between 14 and 16 YO, gave informed assent, while the older than 16 YO will give written informed consent. A written informed consent was also gathered from guardians/legal representatives of all adolescent participants under 18 YO. The anonymity of all participants responses was guaranteed, with the use of respondent-specific codes, which were also used to link the data from one time point to the other. Data was collectively collected in each RCH with the presence of an independent researcher, in order to answer any questions and ensure confidentiality. All participants (caregivers and adolescents) were assessed through self-report measures 5 times across 12 months. Specifically, participants were assessed 3 months before the beginning of the CMT-C (Baseline 0 - time 0), before the first session of the program (baseline 1 - 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 were assessed with the same time intervals as those in intervention group.

After the first baseline assessment, a computer-generated randomization was conducted at the cluster level, following a completely randomized design. Each RCH (i.e., cluster) was randomly assigned to one of two conditions: CMT-C and control group. Six RCH were allocated in the experimental group and received the TMC for caregivers, the remaining 6 constituted the control group. Caregivers in the treatment group attended the CMT-C for about 12 weeks. The CMT-C consisted of twelve, 2.5-hr weekly group sessions, delivered in each RCH to a group of 7 to 10 participants. Caregivers in the control group did not received any mind training or group intervention.

After post-treatment assessments, focus groups were carried out with the caregivers allocated in the CMT-C group, in order to enrich understanding about the participants' experience with the intervention and their perception of change at 3 different levels (individual, interindividual and organizational).

Treatment integrity were ensured through: a) specific treatment manuals; b) direct training of the therapist; c) supervision; and d) assessment of adherence and competence through an integrity rating scale.

Treatment effects will be analyzed following an intention-to-treat analysis using Latent Growth Curve Models (LGCM). The intercept (i.e., initial status) and slope (i.e., change over time) will be modeled as latent variables from longitudinal data (T0 to T4). Per-protocol analysis will also be carried out to investigate treatment effects in completers. Moderator (e.g., clusters) effects will also be tested with Conditional LGCM, and will be included as predictors of change over time in the outcome measures. Nested qualitative evaluation with thematic analysis will be carried out after the last follow-up.

Conditions

Compassion

Study Design

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

Study Groups

CMT-C group

Compassion Mind Training for Caregivers (CMT-C) is a 12-session structured program to be delivered in a group format, aiming to cultivate a compassionate-self and compassionate care practices in residential youth care.

Group Type: EXPERIMENTAL

Compassionate Mind Training for Caregivers

Intervention Type: BEHAVIORAL

CMT-C is a 12-session group program, each lasting about 2,5 hours, which run on a weekly basis. The program is organized across 3 modules: 1) Our mind according to a compassion-based approach (to provide insight into the evolved and socially shaped mind and the affect regulation systems); 2) Compassionate mind training (understanding and cultivating the attributes and competencies of compassion in its three flows, and addressing its fears); and 3) final session (revising key information and practices and its application to the RCH practices/routines). Its sessions have the following structure: 1) Check-in (grounding exercise, reviewing the previous session, sharing the weekly practice); 2) Exploration of the session theme (psychoeducation and experiential practices followed by group opportunities for share experiences and discussion); 3) Check-out (session summary and application to the self, youths and RCH practices, weekly practice challenge, session evaluation, session take-off).

Control group

This group did not receive any mind training or group intervention during the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Compassionate Mind Training for Caregivers

CMT-C is a 12-session group program, each lasting about 2,5 hours, which run on a weekly basis. The program is organized across 3 modules: 1) Our mind according to a compassion-based approach (to provide insight into the evolved and socially shaped mind and the affect regulation systems); 2) Compassionate mind training (understanding and cultivating the attributes and competencies of compassion in its three flows, and addressing its fears); and 3) final session (revising key information and practices and its application to the RCH practices/routines). Its sessions have the following structure: 1) Check-in (grounding exercise, reviewing the previous session, sharing the weekly practice); 2) Exploration of the session theme (psychoeducation and experiential practices followed by group opportunities for share experiences and discussion); 3) Check-out (session summary and application to the self, youths and RCH practices, weekly practice challenge, session evaluation, session take-off).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

Eligibility criteria for participants:

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role: collaborator

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Laura Filipa Seiça Matias Santos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Rijo, PhD

Role: STUDY_DIRECTOR

CINEICC

Locations

Faculty of Psychology and Educational Sciencies, University of Coimbra

Coimbra, , Portugal

Countries

Portugal

References

Santos L, Pinheiro MDR, Rijo D. The Effects of the Compassionate Mind Training for Caregivers on Professional Quality of Life and Mental Health: Outcomes from a Cluster Randomized Trial in Residential Youth Care Settings. Child Youth Care Forum. 2023 May 3:1-21. doi: 10.1007/s10566-023-09749-6. Online ahead of print.

Reference Type: DERIVED

PMID: 37360762 (View on PubMed)

Other Identifiers

SFRH/BD/132327/2017

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SFRH/BD/132327/2017

Identifier Type: -

Identifier Source: org_study_id