Pregnancy RelatedCare4mommiesNCT07611175
Care4mommies in Action: A Compassion-based Intervention
A study testing Care4mommies and Birth preparation courses in people with Pregnancy Related, run by Portucalense University at 1 site in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Care4mommies and Birth preparation courses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jan 2026to 8 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being between 26 and 33 weeks into a single-fetus pregnancy,
- being fluent in Portuguese
Who cannot join
- currently receiving another psychological intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Portucalense University
Porto, Porto District, 4200-072
Lara N Palmeira, PhD, +351 225 572 000, larap@upt.pt
About this study
Official title: Care4mommies in Action: Promoting Maternal Psychological Adjustment in the Perinatal Period
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.
Read the detailed description
Developing universal mental health promotion actions in the perinatal period is of paramount importance as the transition to motherhood involves multiple challenges that can hinder women's mental health and well-being. Within the perinatal period, self-compassion seems to be a potentially modifiable cognitive and emotional protective factor that could be a target of interventions contributing to mothers' psychological adjustment and responsiveness towards the baby. Still, Compassion-based Interventions (CBIs) in this period remain scarce. Thus, the current project aims to explore the acceptability, feasibility, and preliminary efficacy of a CBI during pregnancy on mothers' compassion abilities, and the consequent impact on well-being and quality of mother-baby bonding at postpartum. Feasibility studies are a key component of the iterative process for intervention development. It allows for the assessment of practicality, helps to identify challenges, and resource availability, assesses participant recruitment and retention, ensuring the success and ethical conduct of research endeavours. Ultimately, the outcomes of these studies inform the design of a fully powered randomized controlled trial.
This study goal (i.e., 'Does the Care4mommies intervention work to promote mothers' compassion and higher quality of the mother-baby bonding?') will be accomplished using a pilot cluster randomised trial methodology as defined by the CONSORT. Participants will be recruited from public healthcare facilities within an established partnership with ACES Alto Ave. Inclusion criteria will be women aged between 18 to 49 years old (i.e., fertile age), between 26 to 33 weeks into a single-fetus pregnancy, and fluent in Portuguese; otherwise, exclusion criteria will be currently attending another psychological intervention to prevent potential adverse effects from different theoretical approaches to mental health. These participants will be organised into clusters, which will refer to groups attending birth preparation courses as organised by ACES Alto Ave. Those clusters will be randomly assigned to one of two conditions in a 1:1 ratio by a senior member of the research team, not involved in the implementation of the intervention. The conditions are Care4mommies plus TAU (i.e., birth preparation courses) or TAU only. Based on the information provided by ACES Alto Ave, the expected initial sample is 12 clusters, with between 6 and 8 participants. So, 6 experimental groups and 6 control groups will be conducted, for a total of between 36 and 48 participants in each condition.
Participants in both conditions will be asked to fill in a self-report protocol at comparable times: (T1) one week before the intervention starts, (T2) one week after the intervention has ended, and (T3) three months after the intervention has ended (at postpartum). This protocol will address both primary and secondary outcome variables via self-report questionnaires that have previously been appraised for their psychometric properties using Portuguese adult samples. Primary outcomes will be self-compassion, shame and guilt about caring, and mother-infant bonding. Secondary outcomes will be fear of self-compassion, self-criticism, and mental health. All primary and secondary outcomes will be assessed at the three time-points, except for mother-infant bonding, which will be applicable only at T3. Other self-report measures will be used to control potential confounding variables: depressive symptoms, mother's attachment styles, and maternal-fetal attachment at T1, as well as mothers' perspectives of their baby's temperament at T3. Our primary goal will be to assess change in participants over time across conditions; changes are expected only in the Care4mommies plus TAU condition. As a secondary goal, it will be explored if changes in self-compassion-related variables are significant fixed effects of change in mother-fetal attachment and on postpartum mother-infant bonding.
Researchers expect mothers' self-compassion, mental health, and bonding to their baby will increase from pre- to post-intervention and be sustained in the follow-up period only in the experimental group, whereas shame and guilt about caring, fear of self-compassion, and self-criticism are expected to decrease from pre- to post-intervention and at follow-up.
Data analyses will be based on general linear models considering time, condition, and the time with condition interaction as fixed effects; mothers' depressive symptoms, mothers' attachment style, maternal-fetal attachment, and mothers' perception of the baby's temperament will be taken as random effects, as well as any demographic variables that significantly differ between conditions at pre-intervention. Incidence rate ratios (IRR) and confidence intervals (CI), as well as Intraclass correlation coefficient (ICC), marginal coefficient of determination (marginal R2), and conditional coefficient of determination (conditional R2) will be considered when assessing the model's quality, and level of adjustment. Whenever significant fixed effects are found, differences will be further explored via post-hoc analyses.
Findings from this research will have immediate and noteworthy implications. First, this work will gather evidence on which to tailor an intervention to a specific group and to be delivered within specific ecological contexts where it may be easily and freely accessed by that group. Secondly, this work will gather evidence on the efficacy of that tailored intervention in promoting mental health and the quality of mother-infant bonding. Tailored interventions that are developed jointly with the communities that may come to use them and that have a proven impact are more likely to become institutionalised and an integral part of the offer of a given context. Ultimately, this work may result in diversified offers within healthcare facilities that better address the needs of users in a more comprehensive and integrated manner. To further allow this, a final seminar will be held, and scientific papers will be presented to present the projects' results to a wider community and scientific audience. Moreover, results will also be disseminated to community members (i.e., mothers), academics, and practitioners via the website of the project (https://projetocare4mommie.wixsite.com/care4mommies).
- Conditions
- Pregnancy Related
- Being tested
- Care4mommies, Birth preparation courses
- Keywords
- pregnancy, mother-baby bonding, Compassion focused intervention, self-compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care4mommiesBehavioural
Compassion-focused Therapy based psychological group intervention aimed to cultivate compassion abilities to deal with the challenges of the perinatal period.
Birth preparation coursesOther
Also called Treatment as Usual
Birth preparation courses provided by the ULS Alto-Ave
| Study group | Role | What they receive |
|---|---|---|
| Care4mommies Group | Experimental | Care4mommies is a manualized in-person, compassion-based intervention for pregnant women based on Compassion Focused Therapy (CFT). It comprises 5 weekly sessions of 2h/each aimed to promote mothers' well-being and mother-baby bonding Receives: Behavioral: Care4mommies; Other: Birth preparation courses |
| Treatment as Usual | Active comparator | Usual birth preparation courses delivered by nurses that include theoretical and practical group classes to prepare women for birth and for the challenges of postpartum Receives: Other: Birth preparation courses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three-months follow-up T3 (3 months postpartum)
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.
Measured: 1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).
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.
Measured: three-months follow-up T3 (3 months postpartum)
Secondary outcomes (3)
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.
Measured: 1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).
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.
Measured: 1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).
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.
Measured: 1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start2 Jan 2026
- Primary completion2 Sep 2026 (estimated)
- Study completion8 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portucalense University
- Sponsor type
- University, hospital or other
- Collaborators
- Aveiro University, Unidade Local de Saúde do Alto Ave, EPE
- Responsible party
- Sponsor
- Investigators
- Lara N Palmeira, PhD, Principal investigator, Portucalense University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611175
- Sponsor's protocol ID
- 2023.11605.PEX
- Other IDs
- 2023.11605.PEX, 2023
- Acronym
- Care4mommies
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vagos P, Mateus V, Silva J, Araujo V, Xavier A, Palmeira L. Mother-infant bonding in the first nine months postpartum: the role of mother's attachment style and psychological flexibility. J Reprod Infant Psychol. 2025 Mar;43(2):472-486. doi: 10.1080/02646838.2023.2242379. Epub 2023 Jul 31.
PubMed 37525320
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care4mommies in Action: Promoting Maternal Psychological Adjustment in the Perinatal Period
- ClinicalTrials.gov ID
- NCT07611175
- Acronym / sponsor ID
- Care4mommies / 2023.11605.PEX
- Conditions
- Pregnancy Related
- Keywords
- pregnancy, mother-baby bonding, Compassion focused intervention, self-compassion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Portucalense UniversityUniversity, hospital or other
- Collaborators
- Aveiro University, Unidade Local de Saúde do Alto Ave, EPE
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 8 Dec 2026 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Developing universal mental health promotion actions in the perinatal period is of paramount importance as the transition to motherhood involves multiple challenges that can hinder women's mental health and well-being. Within the perinatal period, self-compassion seems to be a potentially modifiable cognitive and emotional protective factor that could be a target of interventions contributing to mothers' psychological adjustment and responsiveness towards the baby. Still, Compassion-based Interventions (CBIs) in this period remain scarce. Thus, the current project aims to explore the acceptability, feasibility, and preliminary efficacy of a CBI during pregnancy on mothers' compassion abilities, and the consequent impact on well-being and quality of mother-baby bonding at postpartum. Feasibility studies are a key component of the iterative process for intervention development. It allows for the assessment of practicality, helps to identify challenges, and resource availability, assesses participant recruitment and retention, ensuring the success and ethical conduct of research endeavours. Ultimately, the outcomes of these studies inform the design of a fully powered randomized controlled trial.
This study goal (i.e., 'Does the Care4mommies intervention work to promote mothers' compassion and higher quality of the mother-baby bonding?') will be accomplished using a pilot cluster randomised trial methodology as defined by the CONSORT. Participants will be recruited from public healthcare facilities within an established partnership with ACES Alto Ave. Inclusion criteria will be women aged between 18 to 49 years old (i.e., fertile age), between 26 to 33 weeks into a single-fetus pregnancy, and fluent in Portuguese; otherwise, exclusion criteria will be currently attending another psychological intervention to prevent potential adverse effects from different theoretical approaches to mental health. These participants will be organised into clusters, which will refer to groups attending birth preparation courses as organised by ACES Alto Ave. Those clusters will be randomly assigned to one of two conditions in a 1:1 ratio by a senior member of the research team, not involved in the implementation of the intervention. The conditions are Care4mommies plus TAU (i.e., birth preparation courses) or TAU only. Based on the information provided by ACES Alto Ave, the expected initial sample is 12 clusters, with between 6 and 8 participants. So, 6 experimental groups and 6 control groups will be conducted, for a total of between 36 and 48 participants in each condition.
Participants in both conditions will be asked to fill in a self-report protocol at comparable times: (T1) one week before the intervention starts, (T2) one week after the intervention has ended, and (T3) three months after the intervention has ended (at postpartum). This protocol will address both primary and secondary outcome variables via self-report questionnaires that have previously been appraised for their psychometric properties using Portuguese adult samples. Primary outcomes will be self-compassion, shame and guilt about caring, and mother-infant bonding. Secondary outcomes will be fear of self-compassion, self-criticism, and mental health. All primary and secondary outcomes will be assessed at the three time-points, except for mother-infant bonding, which will be applicable only at T3. Other self-report measures will be used to control potential confounding variables: depressive symptoms, mother's attachment styles, and maternal-fetal attachment at T1, as well as mothers' perspectives of their baby's temperament at T3. Our primary goal will be to assess change in participants over time across conditions; changes are expected only in the Care4mommies plus TAU condition. As a secondary goal, it will be explored if changes in self-compassion-related variables are significant fixed effects of change in mother-fetal attachment and on postpartum mother-infant bonding.
Researchers expect mothers' self-compassion, mental health, and bonding to their baby will increase from pre- to post-intervention and be sustained in the follow-up period only in the experimental group, whereas shame and guilt about caring, fear of self-compassion, and self-criticism are expected to decrease from pre- to post-intervention and at follow-up.
Data analyses will be based on general linear models considering time, condition, and the time with condition interaction as fixed effects; mothers' depressive symptoms, mothers' attachment style, maternal-fetal attachment, and mothers' perception of the baby's temperament will be taken as random effects, as well as any demographic variables that significantly differ between conditions at pre-intervention. Incidence rate ratios (IRR) and confidence intervals (CI), as well as Intraclass correlation coefficient (ICC), marginal coefficient of determination (marginal R2), and conditional coefficient of determination (conditional R2) will be considered when assessing the model's quality, and level of adjustment. Whenever significant fixed effects are found, differences will be further explored via post-hoc analyses.
Findings from this research will have immediate and noteworthy implications. First, this work will gather evidence on which to tailor an intervention to a specific group and to be delivered within specific ecological contexts where it may be easily and freely accessed by that group. Secondly, this work will gather evidence on the efficacy of that tailored intervention in promoting mental health and the quality of mother-infant bonding. Tailored interventions that are developed jointly with the communities that may come to use them and that have a proven impact are more likely to become institutionalised and an integral part of the offer of a given context. Ultimately, this work may result in diversified offers within healthcare facilities that better address the needs of users in a more comprehensive and integrated manner. To further allow this, a final seminar will be held, and scientific papers will be presented to present the projects' results to a wider community and scientific audience. Moreover, results will also be disseminated to community members (i.e., mothers), academics, and practitioners via the website of the project (https://projetocare4mommie.wixsite.com/care4mommies).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Care4mommies Group | Experimental | Behavioral: Care4mommies, Other: Birth preparation coursesCare4mommies is a manualized in-person, compassion-based intervention for pregnant women based on Compassion Focused Therapy (CFT). It comprises 5 weekly sessions of 2h/each aimed to promote mothers' well-being and mother-baby bonding |
| Treatment as Usual | Active comparator | Other: Birth preparation coursesUsual birth preparation courses delivered by nurses that include theoretical and practical group classes to prepare women for birth and for the challenges of postpartum |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- being between 26 and 33 weeks into a single-fetus pregnancy,
- being fluent in Portuguese
Key exclusion criteria (1 listed)
- currently receiving another psychological intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care4mommiesCompassion-focused Therapy based psychological group intervention aimed to cultivate compassion abilities to deal with the challenges of the perinatal period. | Behavioural | Care4mommies Group |
| Birth preparation coursesAlso: Treatment as UsualBirth preparation courses provided by the ULS Alto-Ave | Other | Care4mommies Group, Treatment as Usual |
Primary outcome
Parent Bonding Questionnaire (PBQ)
Time frame: three-months follow-up T3 (3 months postpartum)
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.
Self- Compassion scale from the Compassionate Engagement and Action Scales (CEAS-SC)
Time frame: 1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).
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.
Caring shame and guilt scale- Adapted (CSGS)
Time frame: three-months follow-up T3 (3 months postpartum)
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.
3 secondary outcomes
Fears of Self-Compassion Scale from the Fears of Compassion scales (FSC)
Time frame: 1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).
Forms of Self-Criticising/Attacking & Self-Reassuring Scale (FSCSR)
Time frame: 1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).
Mental health continuum - Short-form (MHC-SF)
Time frame: 1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 37525320Vagos P, Mateus V, Silva J, Araujo V, Xavier A, Palmeira L. Mother-infant bonding in the first nine months postpartum: the role of mother's attachment style and psychological flexibility. J Reprod Infant Psychol. 2025 Mar;43(2):472-486. doi: 10.1080/02646838.2023.2242379. Epub 2023 Jul 31.
- Project's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lara N Palmeira, PhD principal investigator
Portucalense University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care4mommies and Birth preparation courses in people with Pregnancy Related, run by Portucalense University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lara N Palmeira, PhD (+351 225 572 000, larap@upt.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Bonding Questionnaire (PBQ) (time frame: three-months follow-up T3 (3 months postpartum)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07611175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.