Maternal-Fetal RelationsNCT05241600
Neurobehavioral Effects of Prenatal Mindfulness Training on Maternal Presence and Compassionate Love
A study testing Mindfulness-Based Childbirth and Parenting and Non-Mindfulness-Based Childbirth Class in people with Maternal-Fetal Relations and Mother-Child Relations, run by Heidemarie Laurent at 2 sites in United States.
Trial summary
This study investigates how prenatal mindfulness training fosters prosocial qualities a mother brings to parenting-specifically, her ability to be present with and experience compassionate love for her child. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal-Fetal Relations, Mother-Child Relations, Maternal Behavior
- What is being tested?
- Mindfulness-Based Childbirth and Parenting and Non-Mindfulness-Based Childbirth Class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2018to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who
- Are less than 28 weeks pregnant.
- Are expecting a singleton child.
- Are between 18 and 40 years old.
- Speak English: Because many of the measures employed in the study have not been validated in other languages, we would not be able to offer equivalent birthing classes in other languages, and we do not have researcher staff who are fluent in other languages, participants must be able to understand written/spoken English.
- Have a Penn State Worry Questionnaire score greater than 50.
- Live within 40 miles and are willing to come for brain scanning to the university-affiliated neuroimaging center OR live greater than 40 miles away and are willing to travel for the videorecording and brain scanning sessions.
Who cannot join
- Pregnant women/new mothers will be excluded if they have
- MRI contraindications
- A serious medical or mental health condition that could impact their ability to participate in study activities. Should a participant endorse a medical or mental health condition that could prevent them from participating in study activities or sessions, a research coordinator, in consultation with the PI, will have a discussion with the participant about whether they feel their condition would prevent them from participating.
- An existing formal mindfulness or long-term yoga practice
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois Urbana-Champaign
Champaign, Illinois, 61820
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: Coping With it All From Labor to Maternity
This study investigates how prenatal mindfulness training fosters prosocial qualities a mother brings to parenting-specifically, her ability to be present with and experience compassionate love for her child. The mother-child relationship profoundly shapes the way humans learn to experience the world and relate to other people. It is known that mothers who respond more sensitively to their infant's emotional cues form more secure attachment relationships that, in turn, foster positive social-emotional development in the child. Thus, programs that strengthen the capacities supporting maternal sensitivity, such as mothers' ability to attend fully to their child's range of emotions with compassion and lovingkindness, hold great potential for promoting intergenerational well-being. Ideally, such capacities would be cultivated before the child is even born so as to have the greatest cumulative impact.
Mindfulness-Based Childbirth and Parenting (MBCP) is a 9-week program developed to train pregnant women and their partners in the foundations of mindfulness and prepare them to apply mindfulness to birthing and parenting an infant. The intervention has shown beneficial effects on women's psychological wellbeing but has not yet been studied in relation to parenting outcomes. In addition, little is known about (a) biobehavioral mechanisms of action in MBCP, and (b) characteristics of expectant mothers that may moderate the impact of the training. It is important to address these gaps to determine the scope of prenatal mindfulness training effects and who could benefit most from such a program.
Read more
This study aims to fill these gaps through an active comparison, randomized controlled trial (RCT) of MBCP compared to (non-mindfulness-based) childbirth education. The investigators will compare mothers who have completed MBCP to mothers with no mindfulness training on both behavioral (self-report) and biological (neural activation to infant cues) indices of prosocial parenting qualities toward the following aims:
Aim 1: Determine the effect of prenatal mindfulness training on self-report measures of maternal presence and compassionate love.
Hypothesis 1: Mothers who have taken part in MBCP will report higher levels of mindful presence, love, and compassion for their infants. These differences will be evident both immediately following the course and sustained later with their infants.
Aim 2: Determine the effect of prenatal mindfulness training on neural activation to one's infant in regions supporting presence and compassionate love.
Including neural measures may reveal intervention effects not yet obvious at the behavioral level that have important consequences for mother/infant functioning.
Hypothesis 2: Mothers who have taken part in MBCP will show increased neural activation to their infant's emotion cues in brain regions involved in present-centered attention (anterior cingulate cortex [ACC] and dorsolateral prefrontal cortex [dlPFC]), emotional resonance (ACC, insula, ventral prefrontal cortex [vPFC]), and mammalian bonding (striatum).
Aim 3: Identify moderating factors that strengthen the effects of prenatal mindfulness training.
Hypothesis 3: Mothers who begin the class with more risk characteristics (single parent, greater distress) will show greater benefits of MBCP, as will those with higher mindfulness practice dosage.
Addressing these aims will shed much-needed light on the ways that mindfulness training during a key developmental life transition can enhance prosocial qualities that contribute to the health and well-being of subsequent generations.
Read the detailed description
This study was initiated at the PI's previous institution, the University of Illinois at Urbana-Champaign (UIUC), under the approval of the UIUC IRB (protocol 19461). Data collection for participants enrolled at UIUC was concluded in December 2021, and study recruitment and data collection for the remainder of the total sample is to commence at the PI's current institution, the Pennsylvania State University, in January 2022.
Study Procedures
At 20-28 weeks of pregnancy, participants recruited into the study provide informed consent and complete questionnaire measures either in person at the research lab or remotely via phone or Zoom (baseline assessment). Those randomized to MBCP then complete the 9-week class with their partner or other support person, and those assigned to treatment as usual complete an in-person or online birthing class of their choice from a list provided. After taking part in the birthing class, at approximately 37 weeks of pregnancy, women again complete questionnaires remotely (post-class assessment). At 3-4 months postpartum, women complete a final set of questionnaires and take part in a videorecording session with their infant, followed by a brain scanning session at the university-affiliated neuroimaging center.
Consent: Participants who are deemed eligible for the study are contacted to schedule a consent session (in-person or remote). A trained researcher discusses the study protocol and key details of informed consent. Following consent, the researcher discusses what the MRI session will be like and the participant fills out an online safety screener to identify any MRI contraindications. Participants are also asked about availability for birthing classes and to rank the available birthing classes according to their preference.
Birthing Class Assignment + Pre-Class Questionnaire (T1): Between the participant's 20th and 28th week of pregnancy, a study researcher randomly assigns the participant to the treatment (MBCP) or control (birthing class of the participant's choice) condition. The researcher contacts the participant to schedule a birthing class assignment session (T1; by phone or on Zoom). During the birthing class assignment, participants are told whether they have been assigned to the MBCP course or are able to choose a birthing class from the provided list. They are asked whether they have any questions about their assignment and provided with instructions on how to sign up for their class/seek reimbursement, as needed. Following the session, participants are sent a personalized link to the first questionnaire by email for them to complete.
Child-bearers randomized to MBCP complete the 9-week class with their partner or other support person. The class is taught by experienced midwives or social workers who have completed MBCP teacher training requirements, which include ongoing cultivation of a personal mindfulness practice as well as education and supervision specific to the MBCP program. Participants in this condition have the option of participating in one of several online MBCP classes available that accommodates their pregnancy timeline. Each three-hour MBCP class comprises a mix of instructor-guided mindful meditation practice (e.g., engaging in a body scan, breath meditation; prenatal yoga practice) and inquiry, in which instructors lead discussion of participants' experiences of the practice and how it applies to their lives. Classes also involve psychoeducation on the experience of and ways to engage with pregnancy, birth, and parenting from a mindfulness perspective. Participants are encouraged to engage in at-home practice: at least thirty minutes of formal and/or informal mindfulness practices modeled in class six days a week, and to read Mindful Birthing, a companion book written by MBCP developer Nancy Bardacke.
Child-bearers randomized to the treatment as usual group participate (also with a partner) in a childbirth class of their choice from a list provided. To maintain ecological validity of this treatment as usual condition, using an established comparative-effectiveness/pragmatic trial approach, no attempt is made to control the length or contact hours of the class, but a range of classes with varying time commitments are offered, and this information is collected at the post-class assessment and considered as a control variable in analyses. No data collection occurs during any of the classes.
Post-Class Assessment (T2): At approximately 37 weeks of pregnancy (following birthing class completion), participants are emailed a personalized link to a post-class questionnaire for them to complete at home.
Post-Birth Assessment (T3.1): Approximately three months after their infant is born, participants are emailed a personalized link to a post-birth questionnaire for them to complete at home.
Videorecording Visit (T3.2): If the participant indicates they are comfortable with in-person sessions, a researcher schedules a time to visit their home to videorecord the participant interacting with their infant. At the start, mothers are instructed to play with their infant as they normally would for ten minutes (freeplay). Mothers can feel free to play games, sing, use toys, or read books during freeplay. Following freeplay, mother are asked to engage in a structured peekaboo interaction with their infant, which is designed to elicit positive infant affect. During peekaboo, mothers are asked to hold their hands over their eyes and call their baby's name, then reveal their eyes and say "peekaboo." They repeat the above for two and a half minutes. This task may be repeated up to two more times, if needed.
Then mothers are asked to engage in an arm-restraint task (holding the infant's arms gently by their side to restrict movement while adopting a neutral, still expression), a task designed to elicit distress in infants at this age. This task lasts up to two and a half minutes, although the researcher may stop this task early if the baby is quite distressed. Two 12-second video segments each of infant positive and negative emotion expression (4 total) are selected for presentation in the scanner. Positive/negative video segments of an infant not involved in the study are also collected using similar procedures to create the "other infant" stimuli. Non-infant comparison stimuli are created by editing the unfamiliar infant videos using Matlab Image Scramble and time-domain audio scrambling with shufflewins to create scrambled videos with similar audiovisual characteristics but no recognizable infant features.
Brain Scanning Session (T3.3): After the home visit, participants are scheduled for an MRI session at the university-affiliated neuroimaging center. During this session, participants complete five study scans: two resting state scans (6 minutes, 12 seconds each), a structural scan (5 minutes, 21 seconds), and two functional scans where they view the video clips of their own and another unknown infant, as well as non-infant stimulus blocks (8 minutes, 12 seconds each). The total duration of the scan is 45 minutes.
Functional Scanning - Regional brain activity is assessed with blood oxygen level dependent echoplanar images (BOLD-EPI), T2*-weighted gradient echo sequence, TR = 2 s, TE = 25 ms, flip angle = 90 deg, 38 slices of thickness 3.0 mm, with a slice gap of 0.3 mm, 92 x 92 voxel matrix, FOV = 230 mm.
Structural Scanning - Functional data are mapped onto high-resolution T1-weighted structural images using 3-DMagnetization-Prepared RApid Gradient Echo (MPRAGE) pulse sequence, TR = 23000 ms, TE = 2.32 ms, TI = 900 ms, flip angle = 8 deg, 192 sagittal slices of thickness 0.9 mm, 256 x 256 matrix, FOV = 240 mm.
Mothers view the videos via a mirror positioned over their eyes and hear accompanying sounds via headphones (sound check prior to scanning to ensure audibility). Functional runs present each stimulus block 6 times (3 presentations each of unique positive and negative own infant/other infant/scrambled video segments), in counterbalanced order. Video stimuli accompanied by sound were chosen based on previous research showing stronger neural responses to dynamic (as opposed to still) emotion faces, and the investigators' own work showing mindfulness-related effects on mothers' neural response to similar infant videos. Stimulus presentation protocols were informed by previous maternal neuroimaging research. Following scanning, mothers are asked through both open-ended and forced-choice questions what they were doing during the task (distraction or suppression of emotion, mindfulness practice, etc.). They also rate their own and their infant's emotional valence and intensity during each video segment. Reported activities and emotion ratings will be considered as possible covariates in fMRI analysis.
Study Data Analysis
Baseline characteristics of the sample, stratified by experimental group, will be examined to ensure even distribution of key variables. Completers and drop-outs will be compared on baseline variables, and those showing group differences will be considered as covariates in tests of hypotheses. Primary analyses will be conducted with the full sample according to intent-to-treat principles under CONSORT guidelines.
Aim 1: MBCP > self-reported maternal presence and compassionate love. To test Hypothesis 1 that MBCP mothers will show higher levels of these qualities, both following the course and later with their infants, hierarchical linear modeling (HLM) will be used to examine the main effect of experimental group (expressed as a dummy-coded variable indicating MBCP participation) on slopes of self-report measures of presence and compassionate love across all three assessments, as well as post-intervention levels. These models will demonstrate whether MBCP results in increased levels of these qualities, both more generally and specifically with the mother's own infant.
Aim 2: MBCP > neural response to one's infant. To test Hypothesis 2 that MBCP mothers will show increased neural activation to their infant's emotion cues in brain regions supporting the above qualities-i.e., ACC, dlPFC, insula, vPFC, and striatum-group comparisons will be conducted using the FSL program.
At the intrasubject level, multiple regression with OLS and adjustment for autocorrelation will test contrasts of stimulus-specific regressors. Boxcar models reflecting onset-offset of each infant stimulus will be convolved with an optimal basis set for HRF, generated using FLOBS. Results will be averaged across the 2 runs using fixed-effects analysis. Based on both theorized MBCP mechanisms of action and previous research on mindfulness-related maternal brain effects, two aspects of maternal neural response will be examined as outcomes: (1) more general responsiveness to their infant, indexed by contrasts of activation to own > other infant and own-infant > non-infant videos, and (2) valenced responses to their infant, indexed by contrasts of positive > negative own-infant videos.
At the group level, MBCP-related differences in each of these responses will be tested via MBCP > Control and Control > MBCP contrasts with mixed-effects analysis (FLAME) in the whole brain. Cluster threshold correction with Z > 2.6 and FDR < .05 will be used to define regions of significantly different activation, and correspondence with brain atlas-defined anatomical regions will determine whether hypothesized sites of elevated responsiveness are supported.
Aim 3: Identify MBCP moderators. To test Hypothesis 3 that mothers who begin the class with more risk characteristics and/or who receive a higher dosage of mindfulness practice will show greater benefits of MBCP, interaction terms involving moderator variables will be added to the above models. Based on the hypotheses outlined above, investigators expect significant positive interactions between MBCP participation and single relationship status, distress, and practice dosage.
- Being tested
- Mindfulness-Based Childbirth and Parenting, Non-Mindfulness-Based Childbirth Class
- Keywords
- Perinatal, Maternal Mental Health, Mother-Infant Bonding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Childbirth and ParentingBehavioural
MBCP is an adaptation of MBSR that incorporates both standard mindfulness practices (body scan, sitting meditation, mindful movement) and preparation for mindful birthing and parenting an infant. The class is taught by experienced midwives or social workers who have completed MBCP training requirements, which include ongoing cultivation of a personal mindfulness practice as well as education and supervision specific to the MBCP program. See Bardacke (2012) for further description of the MBCP curriculum.
Non-Mindfulness-Based Childbirth ClassBehavioural
Other childbirth preparation classes available either in-person in the local community or online that do not involve formal mindfulness training will serve as the comparator condition.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Childbirth and Parenting (MBCP) | Experimental | Child-bearers randomized to MBCP participate in the 9-week course with a partner (co-parenting partner or other support person who will be involved in the birth). During the training, mothers receive instruction in formal and informal mindfulness practices, and how these apply to the experience of childbirth and parenting an infant. Each weekly 3-hour class includes demonstration and discussion of a practice to be carried out at home over the coming week. Receives: Behavioral: Mindfulness-Based Childbirth and Parenting |
| Treatment as Usual (TAU) | Active comparator | Child-bearers randomized to the treatment as usual comparison group participate (also with a partner) in a non-mindfulness-based childbirth class of their choice from a list provided. To maintain ecological validity of this treatment as usual condition, using an established comparative-effectiveness/pragmatic trial approach, no attempt is made to control the length or contact hours of the class. Receives: Behavioral: Non-Mindfulness-Based Childbirth Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five Facet Mindfulness Questionnaire
Measure of maternal mindful presence across time points; score range 1-5; higher scores indicate better outcome.
Measured: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Inventory of Mindfulness in Parenting - Infant Measure
Measure of maternal mindful presence with infant at final time point; score range 1-5; higher scores indicate better outcome.
Measured: Time 3 (3 months postnatal)
Compassion Scale
Measure of maternal compassion across time points; score range 1-5; higher scores indicate better outcome.
Measured: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Prenatal Antenatal Attachment Scale
Measure of maternal bonding with fetus at first two time points; score range 1-5; higher scores indicate better outcome.
Measured: Time 1 (20-28 weeks pregnancy) and Time 2 (37 weeks pregnancy)
Maternal Postnatal Attachment Scale
Measure of maternal bonding with infant at final time point; score range 1-5; higher scores indicate better outcome.
Measured: Time 3 (3 months postnatal)
Maternal Neural Response to Infant
Mothers' BOLD signal during the infant task; functional MRI scans will be analyzed as described above. In particular, two aspects of maternal neural response will be examined as outcomes: (1) more general responsiveness to their infant, indexed by contrasts of activation to own > other infant and own infant > non-infant videos, and (2) valenced responses to their infant, indexed by contrasts of positive > negative own infant videos.
Measured: Time 3 (3 months postnatal)
Secondary outcomes (8)
Edinburgh Postnatal Depression Scale
Measure of maternal distress (mood problems) across time points; score range 0-3; higher scores indicate worse outcome.
Measured: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Perceived Stress Scale
Measure of maternal distress (subjective stress) across time points; score range 0-4; higher scores indicate worse outcome.
Measured: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Penn State Worry Questionnaire
Measure of maternal distress (anxiety) across time points; score range 1-5; higher scores indicate worse outcome
Measured: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Center for Epidemiologic Studies Depression Scale
Measure of maternal distress (depression) across time points; score range 0-3; higher scores indicate worse outcome
Measured: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Ruminative Responses Scale
Measure of maternal distress (rumination) across time points; score range 1-4; higher scores indicate worse outcome
Measured: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Parenting Stress Index - Short Form
Measure of maternal parenting stress at final time; score range 1-5; higher scores indicate worse outcome
Measured: Time 3 (3 months postnatal)
Self-Compassion Scale
Measure of maternal self-compassion at post-intervention; score range 1-5; higher scores indicate better outcome
Measured: Time 2 (37 weeks pregnancy)
Positive and Negative Affect Scale
Measure of maternal affect at brain scan session; score range 1-5; higher scores for Positive indicate better outcome; higher scores for Negative indicate worse outcome
Measured: Time 3 (3 months postnatal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Dec 2018
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Maternal-Fetal RelationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the MBCP condition (intervention under study) or treatment as usual condition (non-mindfulness-based childbirth class of participant's choice from a list provided).
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidemarie Laurent
- Sponsor type
- University, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts, University of Wisconsin, Madison
- Responsible party
- Sponsor-investigator, Heidemarie Laurent, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241600
- Sponsor's protocol ID
- 19138
- Other IDs
- 19461
- Status last verified
- Jun 2024
- First submitted
- 26 Jan 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do plan to share some portion of (deidentified) data in an open access research platform but are still determining which types of data to share and what the most appropriate platform would be.
Publications
Bardacke, N. (2012). Mindful birthing: Training the mind, body, and heart for childbirth and beyond. HarperCollins.
Duncan LG, Bardacke N. Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period. J Child Fam Stud. 2010 Apr;19(2):190-202. doi: 10.1007/s10826-009-9313-7. Epub 2009 Oct 10.
PubMed 20339571Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017 May 12;17(1):140. doi: 10.1186/s12884-017-1319-3.
PubMed 28499376Laurent HK, Ablow JC. The missing link: mothers' neural response to infant cry related to infant attachment behaviors. Infant Behav Dev. 2012 Dec;35(4):761-72. doi: 10.1016/j.infbeh.2012.07.007. Epub 2012 Sep 13.
PubMed 22982277Laurent HK, Duncan LG, Lightcap A, Khan F. Mindful parenting predicts mothers' and infants' hypothalamic-pituitary-adrenal activity during a dyadic stressor. Dev Psychol. 2017 Mar;53(3):417-424. doi: 10.1037/dev0000258. Epub 2016 Nov 28.
PubMed 27893234Laurent HK, Wright D, Finnegan M. Mindfulness-related differences in neural response to own infant negative versus positive emotion contexts. Dev Cogn Neurosci. 2018 Apr;30:70-76. doi: 10.1016/j.dcn.2018.01.002. Epub 2018 Jan 5.
PubMed 29331659Montague DP, Walker-Andrews AS. Peekaboo: a new look at infants' perception of emotion expressions. Dev Psychol. 2001 Nov;37(6):826-38.
PubMed 11699756Moscardino U, Axia G. Infants' responses to arm restraint at 2 and 6 months: a longitudinal study. Infant Behav Dev. 2006 Jan;29(1):59-69. doi: 10.1016/j.infbeh.2005.07.002. Epub 2005 Aug 3.
PubMed 17138262Musser ED, Kaiser-Laurent H, Ablow JC. The neural correlates of maternal sensitivity: an fMRI study. Dev Cogn Neurosci. 2012 Oct;2(4):428-36. doi: 10.1016/j.dcn.2012.04.003. Epub 2012 May 10.
PubMed 22652538Laurent HK, Haigler KL, Sbrilli MD, Suzuki K, Duncan LG. The relational dimension in mindfulness intervention effects: results of a randomized controlled trial of mindfulness-based childbirth and parenting. BMC Pregnancy Childbirth. 2025 May 10;25(1):560. doi: 10.1186/s12884-025-07676-z.
PubMed 40348986
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping With it All From Labor to Maternity
- ClinicalTrials.gov ID
- NCT05241600
- Acronym / sponsor ID
- 19138
- Keywords
- Perinatal, Maternal Mental Health, Mother-Infant Bonding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Heidemarie LaurentUniversity, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts, University of Wisconsin, Madison
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 16 Feb 2022 (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.
This study investigates how prenatal mindfulness training fosters prosocial qualities a mother brings to parenting-specifically, her ability to be present with and experience compassionate love for her child. The mother-child relationship profoundly shapes the way humans learn to experience the world and relate to other people. It is known that mothers who respond more sensitively to their infant's emotional cues form more secure attachment relationships that, in turn, foster positive social-emotional development in the child. Thus, programs that strengthen the capacities supporting maternal sensitivity, such as mothers' ability to attend fully to their child's range of emotions with compassion and lovingkindness, hold great potential for promoting intergenerational well-being. Ideally, such capacities would be cultivated before the child is even born so as to have the greatest cumulative impact.
Mindfulness-Based Childbirth and Parenting (MBCP) is a 9-week program developed to train pregnant women and their partners in the foundations of mindfulness and prepare them to apply mindfulness to birthing and parenting an infant. The intervention has shown beneficial effects on women's psychological wellbeing but has not yet been studied in relation to parenting outcomes. In addition, little is known about (a) biobehavioral mechanisms of action in MBCP, and (b) characteristics of expectant mothers that may moderate the impact of the training. It is important to address these gaps to determine the scope of prenatal mindfulness training effects and who could benefit most from such a program.
This study aims to fill these gaps through an active comparison, randomized controlled trial (RCT) of MBCP compared to (non-mindfulness-based) childbirth education. The investigators will compare mothers who have completed MBCP to mothers with no mindfulness training on both behavioral (self-report) and biological (neural activation to infant cues) indices of prosocial parenting qualities toward the following aims:
Aim 1: Determine the effect of prenatal mindfulness training on self-report measures of maternal presence and compassionate love.
Hypothesis 1: Mothers who have taken part in MBCP will report higher levels of mindful presence, love, and compassion for their infants. These differences will be evident both immediately following the course and sustained later with their infants.
Aim 2: Determine the effect of prenatal mindfulness training on neural activation to one's infant in regions supporting presence and compassionate love.
Including neural measures may reveal intervention effects not yet obvious at the behavioral level that have important consequences for mother/infant functioning.
Hypothesis 2: Mothers who have taken part in MBCP will show increased neural activation to their infant's emotion cues in brain regions involved in present-centered attention (anterior cingulate cortex [ACC] and dorsolateral prefrontal cortex [dlPFC]), emotional resonance (ACC, insula, ventral prefrontal cortex [vPFC]), and mammalian bonding (striatum).
Aim 3: Identify moderating factors that strengthen the effects of prenatal mindfulness training.
Hypothesis 3: Mothers who begin the class with more risk characteristics (single parent, greater distress) will show greater benefits of MBCP, as will those with higher mindfulness practice dosage.
Addressing these aims will shed much-needed light on the ways that mindfulness training during a key developmental life transition can enhance prosocial qualities that contribute to the health and well-being of subsequent generations.
Detailed description
This study was initiated at the PI's previous institution, the University of Illinois at Urbana-Champaign (UIUC), under the approval of the UIUC IRB (protocol 19461). Data collection for participants enrolled at UIUC was concluded in December 2021, and study recruitment and data collection for the remainder of the total sample is to commence at the PI's current institution, the Pennsylvania State University, in January 2022.
Study Procedures
At 20-28 weeks of pregnancy, participants recruited into the study provide informed consent and complete questionnaire measures either in person at the research lab or remotely via phone or Zoom (baseline assessment). Those randomized to MBCP then complete the 9-week class with their partner or other support person, and those assigned to treatment as usual complete an in-person or online birthing class of their choice from a list provided. After taking part in the birthing class, at approximately 37 weeks of pregnancy, women again complete questionnaires remotely (post-class assessment). At 3-4 months postpartum, women complete a final set of questionnaires and take part in a videorecording session with their infant, followed by a brain scanning session at the university-affiliated neuroimaging center.
Consent: Participants who are deemed eligible for the study are contacted to schedule a consent session (in-person or remote). A trained researcher discusses the study protocol and key details of informed consent. Following consent, the researcher discusses what the MRI session will be like and the participant fills out an online safety screener to identify any MRI contraindications. Participants are also asked about availability for birthing classes and to rank the available birthing classes according to their preference.
Birthing Class Assignment + Pre-Class Questionnaire (T1): Between the participant's 20th and 28th week of pregnancy, a study researcher randomly assigns the participant to the treatment (MBCP) or control (birthing class of the participant's choice) condition. The researcher contacts the participant to schedule a birthing class assignment session (T1; by phone or on Zoom). During the birthing class assignment, participants are told whether they have been assigned to the MBCP course or are able to choose a birthing class from the provided list. They are asked whether they have any questions about their assignment and provided with instructions on how to sign up for their class/seek reimbursement, as needed. Following the session, participants are sent a personalized link to the first questionnaire by email for them to complete.
Child-bearers randomized to MBCP complete the 9-week class with their partner or other support person. The class is taught by experienced midwives or social workers who have completed MBCP teacher training requirements, which include ongoing cultivation of a personal mindfulness practice as well as education and supervision specific to the MBCP program. Participants in this condition have the option of participating in one of several online MBCP classes available that accommodates their pregnancy timeline. Each three-hour MBCP class comprises a mix of instructor-guided mindful meditation practice (e.g., engaging in a body scan, breath meditation; prenatal yoga practice) and inquiry, in which instructors lead discussion of participants' experiences of the practice and how it applies to their lives. Classes also involve psychoeducation on the experience of and ways to engage with pregnancy, birth, and parenting from a mindfulness perspective. Participants are encouraged to engage in at-home practice: at least thirty minutes of formal and/or informal mindfulness practices modeled in class six days a week, and to read Mindful Birthing, a companion book written by MBCP developer Nancy Bardacke.
Child-bearers randomized to the treatment as usual group participate (also with a partner) in a childbirth class of their choice from a list provided. To maintain ecological validity of this treatment as usual condition, using an established comparative-effectiveness/pragmatic trial approach, no attempt is made to control the length or contact hours of the class, but a range of classes with varying time commitments are offered, and this information is collected at the post-class assessment and considered as a control variable in analyses. No data collection occurs during any of the classes.
Post-Class Assessment (T2): At approximately 37 weeks of pregnancy (following birthing class completion), participants are emailed a personalized link to a post-class questionnaire for them to complete at home.
Post-Birth Assessment (T3.1): Approximately three months after their infant is born, participants are emailed a personalized link to a post-birth questionnaire for them to complete at home.
Videorecording Visit (T3.2): If the participant indicates they are comfortable with in-person sessions, a researcher schedules a time to visit their home to videorecord the participant interacting with their infant. At the start, mothers are instructed to play with their infant as they normally would for ten minutes (freeplay). Mothers can feel free to play games, sing, use toys, or read books during freeplay. Following freeplay, mother are asked to engage in a structured peekaboo interaction with their infant, which is designed to elicit positive infant affect. During peekaboo, mothers are asked to hold their hands over their eyes and call their baby's name, then reveal their eyes and say "peekaboo." They repeat the above for two and a half minutes. This task may be repeated up to two more times, if needed.
Then mothers are asked to engage in an arm-restraint task (holding the infant's arms gently by their side to restrict movement while adopting a neutral, still expression), a task designed to elicit distress in infants at this age. This task lasts up to two and a half minutes, although the researcher may stop this task early if the baby is quite distressed. Two 12-second video segments each of infant positive and negative emotion expression (4 total) are selected for presentation in the scanner. Positive/negative video segments of an infant not involved in the study are also collected using similar procedures to create the "other infant" stimuli. Non-infant comparison stimuli are created by editing the unfamiliar infant videos using Matlab Image Scramble and time-domain audio scrambling with shufflewins to create scrambled videos with similar audiovisual characteristics but no recognizable infant features.
Brain Scanning Session (T3.3): After the home visit, participants are scheduled for an MRI session at the university-affiliated neuroimaging center. During this session, participants complete five study scans: two resting state scans (6 minutes, 12 seconds each), a structural scan (5 minutes, 21 seconds), and two functional scans where they view the video clips of their own and another unknown infant, as well as non-infant stimulus blocks (8 minutes, 12 seconds each). The total duration of the scan is 45 minutes.
Functional Scanning - Regional brain activity is assessed with blood oxygen level dependent echoplanar images (BOLD-EPI), T2*-weighted gradient echo sequence, TR = 2 s, TE = 25 ms, flip angle = 90 deg, 38 slices of thickness 3.0 mm, with a slice gap of 0.3 mm, 92 x 92 voxel matrix, FOV = 230 mm.
Structural Scanning - Functional data are mapped onto high-resolution T1-weighted structural images using 3-DMagnetization-Prepared RApid Gradient Echo (MPRAGE) pulse sequence, TR = 23000 ms, TE = 2.32 ms, TI = 900 ms, flip angle = 8 deg, 192 sagittal slices of thickness 0.9 mm, 256 x 256 matrix, FOV = 240 mm.
Mothers view the videos via a mirror positioned over their eyes and hear accompanying sounds via headphones (sound check prior to scanning to ensure audibility). Functional runs present each stimulus block 6 times (3 presentations each of unique positive and negative own infant/other infant/scrambled video segments), in counterbalanced order. Video stimuli accompanied by sound were chosen based on previous research showing stronger neural responses to dynamic (as opposed to still) emotion faces, and the investigators' own work showing mindfulness-related effects on mothers' neural response to similar infant videos. Stimulus presentation protocols were informed by previous maternal neuroimaging research. Following scanning, mothers are asked through both open-ended and forced-choice questions what they were doing during the task (distraction or suppression of emotion, mindfulness practice, etc.). They also rate their own and their infant's emotional valence and intensity during each video segment. Reported activities and emotion ratings will be considered as possible covariates in fMRI analysis.
Study Data Analysis
Baseline characteristics of the sample, stratified by experimental group, will be examined to ensure even distribution of key variables. Completers and drop-outs will be compared on baseline variables, and those showing group differences will be considered as covariates in tests of hypotheses. Primary analyses will be conducted with the full sample according to intent-to-treat principles under CONSORT guidelines.
Aim 1: MBCP > self-reported maternal presence and compassionate love. To test Hypothesis 1 that MBCP mothers will show higher levels of these qualities, both following the course and later with their infants, hierarchical linear modeling (HLM) will be used to examine the main effect of experimental group (expressed as a dummy-coded variable indicating MBCP participation) on slopes of self-report measures of presence and compassionate love across all three assessments, as well as post-intervention levels. These models will demonstrate whether MBCP results in increased levels of these qualities, both more generally and specifically with the mother's own infant.
Aim 2: MBCP > neural response to one's infant. To test Hypothesis 2 that MBCP mothers will show increased neural activation to their infant's emotion cues in brain regions supporting the above qualities-i.e., ACC, dlPFC, insula, vPFC, and striatum-group comparisons will be conducted using the FSL program.
At the intrasubject level, multiple regression with OLS and adjustment for autocorrelation will test contrasts of stimulus-specific regressors. Boxcar models reflecting onset-offset of each infant stimulus will be convolved with an optimal basis set for HRF, generated using FLOBS. Results will be averaged across the 2 runs using fixed-effects analysis. Based on both theorized MBCP mechanisms of action and previous research on mindfulness-related maternal brain effects, two aspects of maternal neural response will be examined as outcomes: (1) more general responsiveness to their infant, indexed by contrasts of activation to own > other infant and own-infant > non-infant videos, and (2) valenced responses to their infant, indexed by contrasts of positive > negative own-infant videos.
At the group level, MBCP-related differences in each of these responses will be tested via MBCP > Control and Control > MBCP contrasts with mixed-effects analysis (FLAME) in the whole brain. Cluster threshold correction with Z > 2.6 and FDR < .05 will be used to define regions of significantly different activation, and correspondence with brain atlas-defined anatomical regions will determine whether hypothesized sites of elevated responsiveness are supported.
Aim 3: Identify MBCP moderators. To test Hypothesis 3 that mothers who begin the class with more risk characteristics and/or who receive a higher dosage of mindfulness practice will show greater benefits of MBCP, interaction terms involving moderator variables will be added to the above models. Based on the hypotheses outlined above, investigators expect significant positive interactions between MBCP participation and single relationship status, distress, and practice dosage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the MBCP condition (intervention under study) or treatment as usual condition (non-mindfulness-based childbirth class of participant's choice from a list provided).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Childbirth and Parenting (MBCP) | Experimental | Behavioral: Mindfulness-Based Childbirth and ParentingChild-bearers randomized to MBCP participate in the 9-week course with a partner (co-parenting partner or other support person who will be involved in the birth). During the training, mothers receive instruction in formal and informal mindfulness practices, and how these apply to the experience of childbirth and parenting an infant. Each weekly 3-hour class includes demonstration and discussion of a practice to be carried out at home over the coming week. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Non-Mindfulness-Based Childbirth ClassChild-bearers randomized to the treatment as usual comparison group participate (also with a partner) in a non-mindfulness-based childbirth class of their choice from a list provided. To maintain ecological validity of this treatment as usual condition, using an established comparative-effectiveness/pragmatic trial approach, no attempt is made to control the length or contact hours of the class. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women who
- Are less than 28 weeks pregnant.
- Are expecting a singleton child.
- Are between 18 and 40 years old.
- Speak English: Because many of the measures employed in the study have not been validated in other languages, we would not be able to offer equivalent birthing classes in other languages, and we do not have researcher staff who are fluent in other languages, participants must be able to understand written/spoken English.
Key exclusion criteria (4 listed)
- Pregnant women/new mothers will be excluded if they have
- MRI contraindications
- A serious medical or mental health condition that could impact their ability to participate in study activities. Should a participant endorse a medical or mental health condition that could prevent them from participating in study activities or sessions, a research coordinator, in consultation with the PI, will have a discussion with the participant about whether they feel their condition would prevent them from participating.
- An existing formal mindfulness or long-term yoga practice
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 |
|---|---|---|
| Mindfulness-Based Childbirth and ParentingMBCP is an adaptation of MBSR that incorporates both standard mindfulness practices (body scan, sitting meditation, mindful movement) and preparation for mindful birthing and parenting an infant. The class is taught by experienced midwives or social workers who have completed MBCP training requirements, which include ongoing cultivation of a personal mindfulness practice as well as education and supervision specific to the MBCP program. See Bardacke (2012) for further description of the MBCP curriculum. | Behavioural | Mindfulness-Based Childbirth and Parenting (MBCP) |
| Non-Mindfulness-Based Childbirth ClassOther childbirth preparation classes available either in-person in the local community or online that do not involve formal mindfulness training will serve as the comparator condition. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Five Facet Mindfulness Questionnaire
Time frame: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Measure of maternal mindful presence across time points; score range 1-5; higher scores indicate better outcome.
Inventory of Mindfulness in Parenting - Infant Measure
Time frame: Time 3 (3 months postnatal)
Measure of maternal mindful presence with infant at final time point; score range 1-5; higher scores indicate better outcome.
Compassion Scale
Time frame: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Measure of maternal compassion across time points; score range 1-5; higher scores indicate better outcome.
Prenatal Antenatal Attachment Scale
Time frame: Time 1 (20-28 weeks pregnancy) and Time 2 (37 weeks pregnancy)
Measure of maternal bonding with fetus at first two time points; score range 1-5; higher scores indicate better outcome.
Maternal Postnatal Attachment Scale
Time frame: Time 3 (3 months postnatal)
Measure of maternal bonding with infant at final time point; score range 1-5; higher scores indicate better outcome.
Maternal Neural Response to Infant
Time frame: Time 3 (3 months postnatal)
Mothers' BOLD signal during the infant task; functional MRI scans will be analyzed as described above. In particular, two aspects of maternal neural response will be examined as outcomes: (1) more general responsiveness to their infant, indexed by contrasts of activation to own > other infant and own infant > non-infant videos, and (2) valenced responses to their infant, indexed by contrasts of positive > negative own infant videos.
8 secondary outcomes
Edinburgh Postnatal Depression Scale
Time frame: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Perceived Stress Scale
Time frame: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Penn State Worry Questionnaire
Time frame: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Center for Epidemiologic Studies Depression Scale
Time frame: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Ruminative Responses Scale
Time frame: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)
Parenting Stress Index - Short Form
Time frame: Time 3 (3 months postnatal)
Self-Compassion Scale
Time frame: Time 2 (37 weeks pregnancy)
Positive and Negative Affect Scale
Time frame: Time 3 (3 months postnatal)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- BackgroundBardacke, N. (2012). Mindful birthing: Training the mind, body, and heart for childbirth and beyond. HarperCollins.
- Background: PubMed 20339571Duncan LG, Bardacke N. Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period. J Child Fam Stud. 2010 Apr;19(2):190-202. doi: 10.1007/s10826-009-9313-7. Epub 2009 Oct 10.
- Background: PubMed 28499376Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017 May 12;17(1):140. doi: 10.1186/s12884-017-1319-3.
- Background: PubMed 22982277Laurent HK, Ablow JC. The missing link: mothers' neural response to infant cry related to infant attachment behaviors. Infant Behav Dev. 2012 Dec;35(4):761-72. doi: 10.1016/j.infbeh.2012.07.007. Epub 2012 Sep 13.
- Background: PubMed 27893234Laurent HK, Duncan LG, Lightcap A, Khan F. Mindful parenting predicts mothers' and infants' hypothalamic-pituitary-adrenal activity during a dyadic stressor. Dev Psychol. 2017 Mar;53(3):417-424. doi: 10.1037/dev0000258. Epub 2016 Nov 28.
- Background: PubMed 29331659Laurent HK, Wright D, Finnegan M. Mindfulness-related differences in neural response to own infant negative versus positive emotion contexts. Dev Cogn Neurosci. 2018 Apr;30:70-76. doi: 10.1016/j.dcn.2018.01.002. Epub 2018 Jan 5.
- Background: PubMed 11699756Montague DP, Walker-Andrews AS. Peekaboo: a new look at infants' perception of emotion expressions. Dev Psychol. 2001 Nov;37(6):826-38.
- Background: PubMed 17138262Moscardino U, Axia G. Infants' responses to arm restraint at 2 and 6 months: a longitudinal study. Infant Behav Dev. 2006 Jan;29(1):59-69. doi: 10.1016/j.infbeh.2005.07.002. Epub 2005 Aug 3.
- Background: PubMed 22652538Musser ED, Kaiser-Laurent H, Ablow JC. The neural correlates of maternal sensitivity: an fMRI study. Dev Cogn Neurosci. 2012 Oct;2(4):428-36. doi: 10.1016/j.dcn.2012.04.003. Epub 2012 May 10.
- Derived from this study: PubMed 40348986Laurent HK, Haigler KL, Sbrilli MD, Suzuki K, Duncan LG. The relational dimension in mindfulness intervention effects: results of a randomized controlled trial of mindfulness-based childbirth and parenting. BMC Pregnancy Childbirth. 2025 May 10;25(1):560. doi: 10.1186/s12884-025-07676-z.
- Individual participant dataSharing planned: Undecided. We do plan to share some portion of (deidentified) data in an open access research platform but are still determining which types of data to share and what the most appropriate platform would be.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Childbirth and Parenting and Non-Mindfulness-Based Childbirth Class in people with Maternal-Fetal Relations and Mother-Child Relations, run by Heidemarie Laurent at 2 sites in United States.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five Facet Mindfulness Questionnaire (time frame: Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)). The study lists 6 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 NCT05241600, which also lists 10 linked publications.
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 2 Apr 2025.