Clinical trial NCT04512092: The Efficacy of a Compassionate Mind Training Program With Caregivers of Residential Youth Care
Official title: Affiliative Mentality in Residential Youth Care: A Cluster Randomized Trial of a Compassionate Mind Training Program With Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Compassion
Keywords: Residential Care
Compassionate Mind Training
Caregivers
Children and adolescents at risk
Compassion
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2020-08-13
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Compassion
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Change of Self-Compassion
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Change of Fears of Compassion
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Change of Social Safeness
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Change of Emotional Climate at the workplace
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
Secondary outcomes:
measure: Emotion regulation
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Mental Health Symptoms
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Professional Quality of Life
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Empathy
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Resilience
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Satisfaction with life
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Positive and negative affect
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Warmth and Safeness experiences
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Social safeness
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Emotional Climate in Residential Care Home
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
measure: Internalizing and externalizing problems
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
Other outcomes:
measure: Focus groups for the assessement of organizational change
timeFrame: Two weeks after post-intervention assessments
Locations:
city: Coimbra
country: Portugal
facility: Faculty of Psychology and Educational Sciencies, University of Coimbra
Study officials:
affiliation: CINEICC
name: Daniel Rijo, PhD
role: STUDY_DIRECTOR
References: