The Efficacy of a Compassionate Mind Training Program With Caregivers of Residential Youth Care
The Efficacy of a Compassionate Mind Training Program With Caregivers of Residential Youth Care
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.
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.
Eligibility criteria for clusters:

 Inclusion criteria: Residential care homes (RCH) in the Centre region of Portugal,
 receiving adolescents (both genders) aged between 12 and 25 YO.

 Exclusion criteria: RCH mostly receiving children or specialized in mental and behavioural
 disorders/substance abuse problems will be excluded (to control for mental health
 treatments delivered in these RCH).

 Eligibility criteria for participants:

 Inclusion criteria for caregivers: Professionals working in RCH and directly interacting
 with the adolescents on a regular basis.

 Inclusion criteria for adolescents: have entered in the RCH at least 1-month before the
 study's onset (adjustment time); aged between 12 and 25 YO.

 Exclusion criteria for adolescents: cognitive impairment; remaining in residential care for
 less than 9 months.