NCT04512092

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

2.7 years

First QC Date

August 6, 2020

Last Update Submit

September 28, 2021

Conditions

Keywords

Residential CareCompassionate Mind TrainingCaregiversChildren and adolescents at riskCompassion

Outcome Measures

Primary Outcomes (5)

  • Change of Compassion

    Caregivers reported on the Compassion Scale (CS; Pommier, 2011; Portuguese version by Sousa, Castilho, Vieira, Vagos, \& Rijo, 2017). The CS is a 24-item self-report scale that measures compassion for others. Participants answered each item according to how frequently they feel and act towards others, using a 5-point Likert scale (1 = almost never, to 5 = almost always). In the Portuguese version, a CFA revealed the existence of six subscales and two higher-order factors: Compassion (comprising the positive subscales: Kindness, Common Humanity, Mindfulness) and Disconnectedness (comprising the negative subscales: Indifference, Separation and Disengagement), which represent a positive and a negative valence of compassion.

    baseline; 3 months; 6 months; 9 months; 12 months

  • Change of Self-Compassion

    Caregivers reported on the Self-Compassion Scale (SCS; Neff, 2003; Portuguese version by Castilho, Pinto-Gouveia \& Duarte, 2015). The SCS is a 26 self-reported scale which addresses self-compassion and instructs participants to answer its items, rated in a 5-point Likert scale (1 = almost never, to 5 = almost always), regarding "how I typically act towards myself in difficult times". In the original version, the scale has a total score and six subscales (Self-Kindness; Self-Judgement; Common Humanity; Isolation; Mindfulness; and Over-Identification). The Portuguese version tested a two-factor model, finding that a Self-Compassionate attitude (comprising the positive subscales: Self-Kindness, Common Humanity, Mindfulness) and Self-Critical attitude (comprising the negative subscales: Self-Judgement, Isolation and Over-Identification).

    baseline; 3 months; 6 months; 9 months; 12 months

  • Change of Fears of Compassion

    Caregivers reported on the Fears of Compassion Scales (FCS; Gilbert, McEwan, Matos, \& Rivis, 2011; Portuguese version by Matos, Pinto-Gouveia, Duarte, \& Simões, 2011). The FCS integrates three self-reported scales designed to assess fears of being compassionate toward others (10 items), receiving compassion from others (13 items) and being self-compassionate (15 items). The items were rated on a 5-point Likert scale (0 = Do not agree at all, to 4 = Completely agree).

    baseline; 3 months; 6 months; 9 months; 12 months

  • Change of Social Safeness

    Caregivers reported on the Social Safeness and Pleasure Scale (SSPS; Gilbert et al., 2009; Portuguese version by Dinis, Castilho, Xavier, \& Pinto-Gouveia, 2008). The SSPS is an 11-item unidimensional self-reported scale that assesses the frequency with which individuals experience positive feelings in their social relationships, as well as, they experience the world as a safe and soothing place. Items are rated through a 5-point Likert scale (1 =almost never, to 5=almost always).

    baseline; 3 months; 6 months; 9 months; 12 months

  • Change of Emotional Climate at the workplace

    Caregivers reported on the Emotional Climate in Organizations Scale Adults (ECOS-A; Albuquerque et al., 2018). The ECOS-A is a 30-item self-report scale, aiming to assess how workers felt and behaved at their workplace, over the past two weeks. This scale has two parts (i.e., emotions and motives) with 15 items each. Each one is divided into 3 subscales, with 5 items, referring to the three affect's regulation systems: the threat system, the soothing system and the drive system. All items are answered according to a 5-points Likert's scale (0 =Never, to 4= Always).

    baseline; 3 months; 6 months; 9 months; 12 months

Secondary Outcomes (11)

  • Emotion regulation

    baseline; 3 months; 6 months; 9 months; 12 months

  • Mental Health Symptoms

    baseline; 3 months; 6 months; 9 months; 12 months

  • Professional Quality of Life

    baseline; 3 months; 6 months; 9 months; 12 months

  • Empathy

    baseline; 3 months; 6 months; 9 months; 12 months

  • Resilience

    baseline; 3 months; 6 months; 9 months; 12 months

  • +6 more secondary outcomes

Other Outcomes (1)

  • Focus groups for the assessement of organizational change

    Two weeks after post-intervention assessments

Study Arms (2)

CMT-C group

EXPERIMENTAL

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.

Behavioral: Compassionate Mind Training for Caregivers

Control group

NO INTERVENTION

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

Interventions

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).

CMT-C group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Eligibility criteria for participants:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology and Educational Sciencies, University of Coimbra

Coimbra, 3001-802, Portugal

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Caregivers

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Daniel Rijo, PhD

    CINEICC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 13, 2020

Study Start

May 1, 2019

Primary Completion

December 30, 2021

Study Completion

January 30, 2022

Last Updated

October 6, 2021

Record last verified: 2021-09

Locations