NCT05241600

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

April 2, 2025

Status Verified

June 1, 2024

Enrollment Period

5.9 years

First QC Date

January 26, 2022

Last Update Submit

March 27, 2025

Conditions

Keywords

PerinatalMaternal Mental HealthMother-Infant Bonding

Outcome Measures

Primary Outcomes (6)

  • Five Facet Mindfulness Questionnaire

    Measure of maternal mindful presence across time points; score range 1-5; higher scores indicate better outcome.

    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.

    Time 3 (3 months postnatal)

  • Compassion Scale

    Measure of maternal compassion across time points; score range 1-5; higher scores indicate better outcome.

    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.

    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.

    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.

    Time 3 (3 months postnatal)

Secondary Outcomes (8)

  • Edinburgh Postnatal Depression Scale

    Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)

  • Perceived Stress Scale

    Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)

  • Penn State Worry Questionnaire

    Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)

  • Center for Epidemiologic Studies Depression Scale

    Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)

  • Ruminative Responses Scale

    Time 1 (20-28 weeks pregnancy) through Time 3 (3 months postnatal)

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Non-Mindfulness-Based Childbirth Class

Interventions

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.

Mindfulness-Based Childbirth and Parenting (MBCP)

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.

Treatment as Usual (TAU)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois Urbana-Champaign

Champaign, Illinois, 61820, United States

Location

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (10)

  • Bardacke, N. (2012). Mindful birthing: Training the mind, body, and heart for childbirth and beyond. HarperCollins.

    BACKGROUND
  • 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.

    PMID: 20339571BACKGROUND
  • Duncan 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.

    PMID: 28499376BACKGROUND
  • Laurent 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.

    PMID: 22982277BACKGROUND
  • Laurent 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.

    PMID: 27893234BACKGROUND
  • Laurent 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.

    PMID: 29331659BACKGROUND
  • Montague DP, Walker-Andrews AS. Peekaboo: a new look at infants' perception of emotion expressions. Dev Psychol. 2001 Nov;37(6):826-38.

    PMID: 11699756BACKGROUND
  • Moscardino 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.

    PMID: 17138262BACKGROUND
  • Musser 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.

    PMID: 22652538BACKGROUND
  • Laurent 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Human Development and Family Studies

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 16, 2022

Study Start

December 1, 2018

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

April 2, 2025

Record last verified: 2024-06

Locations