Care4mommies in Action: A Compassion-based Intervention
ConditionPregnancy Related
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorPortucalense University
About this trial
Becoming a mother is a life-changing event that many experience as a time of joy and affection. However, it can also be a period of great vulnerability and uncertainty with the potential to hinder the mother's well-being and bonding with the baby, and undermine the child's later emotional, social, and cognitive development. The mothers' emotional regulation skills, namely self-compassion, may be useful in protecting the mother and the mother-baby bonding, making them a valuable target of intervention during the perinatal period and a potential protective factor for mental health. Although compassion-based interventions (CBIs) have been proven effective in promoting well-being and reducing mental health difficulties across diverse populations, including the perinatal period, evidence of their impact on maternal well-being and the mother-baby bond remains limited. Thus, the research team propose to explore the acceptability, feasibility, and preliminary efficacy of a CBI during pregnancy on mothers' compassion abilities, and consequent impact on well-being and quality of mother-baby bonding at postpartum.
This pilot cluster randomised trial addresses the research question of 'Does the Care4mommies intervention work to promote mothers' compassion and higher quality of the mother-baby bonding?' Participants will be mothers enrolled in group birth preparation courses (i.e., TAU); those groups will be randomly allocated to Care4mommies plus TAU or TAU only and assessed at pre-intervention and post-intervention(prepartum), and 3-month follow-up(postpartum). At pre- and postintervention, participants will be asked to provide self-reported information on self-compassion, shame and guilt about caring, maternal-fetal attachment, fear of self-compassion, self-criticism, and mental health. At post-intervention, they will also be asked to appraise data collection procedures and the implementation feasibility of the Care4mommies; at follow-up, they will be asked to report on their bonding to their baby. Researchers expect that participants in the Care4mommies plus TAU condition will report significant gains at post-intervention and sustain them until follow-up, both in relation to the mother and in mother-baby bonding, compared to the TAU group. Also it is expected that changes in self-compassion-related variables will explain changes in mother-fetal attachment and postpartum mother-infant bonding.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
being between 26 and 33 weeks into a single-fetus pregnancy,
being fluent in Portuguese
Disqualifiers
currently receiving another psychological intervention
Trial design
Design model
Parallel
Treatments tested in this trial
Care4mommies
BehavioralCompassion-focused Therapy based psychological group intervention aimed to cultivate compassion abilities to deal with the challenges of the perinatal period.
Birth preparation courses
Other interventionBirth preparation courses provided by the ULS Alto-Ave
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Care4mommies GroupExperimental treatment 2 interventions
Group B: Treatment as UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Parent Bonding Questionnaire (PBQ)
The Parent Bonding Questionnaire is a 12-item self-reported questionnaire that assesses Mother-baby bonding. The responses are given on a 6-point Likert scale (ranging from 0 = 'Never' to 5 = 'Always'). Scores range from 0 to 60. Items with negative valence will be reverse-coded so that higher scores reflect better quality of mother-infant bonding.
Time frame
three-months follow-up T3 (3 months postpartum)2
Self- Compassion scale from the Compassionate Engagement and Action Scales (CEAS-SC)
The Self- Compassion scale from the Compassionate Engagement and Action Scales is an 11-item self-reported questionnaire that assesses self-compassion engagement and actions. The responses are given on a 10-point Likert scale (from 1 = "never" to 10 = "always"). Scores range from 11 to 110, with higher scores reflecting more self-compassion abilities.
Time frame
1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).3
Caring shame and guilt scale- Adapted (CSGS)
Caring shame and guilt scale- Adapted is a 12-item self-reported questionnaire that assesses shame and guilt about caring. The responses are given on a 5-point Likert scale (ranging from 1 = "Not at all typical/characteristic of me" to "0 = "Extremely typical/characteristic of me"). Scores range from 0 to 48, with higher scores reflecting higher levels of shame and guilt feelings.
Time frame
three-months follow-up T3 (3 months postpartum)Secondary outcomes
1
Fears of Self-Compassion Scale from the Fears of Compassion scales (FSC)
The Fears of Self-Compassion Scale from the Fears of Compassion scales is a 15-item self-reported questionnaire that assesses fear of self-compassion. The responses are given on a 5-point Likert scale (from 0 = "completely disagree" to 5 = "completely agree"). Scores range from 0 to 75, with higher scores reflecting higher levels of fear of compassion towards the self.
Time frame
1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).2
Forms of Self-Criticising/Attacking & Self-Reassuring Scale (FSCSR)
The Forms of Self-Criticising/Attacking \& Self-Reassuring Scale is a 22-item self-reported questionnaire that assesses self-criticism and self-reassurance. The responses are given on a 5-point Likert scale (ranging from 0 = not at all like me' to 4 = extremely like me). Scores range from 0 to 88. For this study, only the two subscales regarding self-criticism will be used (inadequate-self with 9 items and hated-self with 5 items), with higher scores reflecting higher levels of self-criticism.
Time frame
1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).3
Mental health continuum - Short-form (MHC-SF)
The Mental Health Continuum Short-form is a 14-item self-reported questionnaire that assesses mental health. The responses are given on a 6-point Likert-type scale (from 0 = "never" to 5 = "every day". Scores range from 0 to 70, with higher scores representing better mental health.
Time frame
1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Portucalense University
Lead sponsor
Aveiro University
Collaborator
Unidade Local de Saúde do Alto Ave, EPE
Collaborator
Source ClinicalTrials.gov