Ignite Creation Date:
2024-05-06 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05241600
Status:
RECRUITING
Last Update Posted:
2023-04-25
First Post:
2022-01-26
Brief Title:
Neurobehavioral Effects of Prenatal Mindfulness Training on Maternal Presence and Compassionate Love
Sponsor:
Heidemarie Laurent
Organization:
Penn State University
Study Overview
Official Title:
Coping With it All From Labor to Maternity
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infants 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 childs 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 womens 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 ones 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 motherinfant functioning
Hypothesis 2 Mothers who have taken part in MBCP will show increased neural activation to their infants 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 history of birth complications or losses 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
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 womens 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 ones 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 motherinfant functioning
Hypothesis 2 Mothers who have taken part in MBCP will show increased neural activation to their infants 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 history of birth complications or losses 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 PIs 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 PIs 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 participants 20th and 28th week of pregnancy a study researcher randomly assigns the participant to the treatment MBCP or control birthing class of the participants 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 classseek 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 eg 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 andor 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-effectivenesspragmatic 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 T31 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 T32 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 babys 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 infants 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 Positivenegative 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 T33 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 30 mm with a slice gap of 03 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 232 ms TI 900 ms flip angle 8 deg 192 sagittal slices of thickness 09 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 infantother infantscrambled 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 infants 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 multiple regression models will examine the main effect of experimental group expressed as a dummy-coded variable indicating MBCP participation on self-report measures of presence and compassionate love at post-class and postnatal times controlling for baseline measures These models will demonstrate whether MBCP results in increased levels of these qualities both more generally and specifically with the mothers own infant
In addition hierarchical linear modeling HLM will be used to compare MBCP and control mothers slopes on each measure available across all three assessments This will offer a more nuanced longitudinal test of how prenatal mindfulness training may impact the development of mindful presence and compassion not specific to ones infant from pregnancy through the first postpartum months
Aim 2 MBCP neural response to ones infant To test Hypothesis 2 that MBCP mothers will show increased neural activation to their infants emotion cues in brain regions supporting the above qualities-ie 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 26 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 andor 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 history of birth complications or losses distress and practice dosage
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 participants 20th and 28th week of pregnancy a study researcher randomly assigns the participant to the treatment MBCP or control birthing class of the participants 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 classseek 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 eg 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 andor 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-effectivenesspragmatic 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 T31 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 T32 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 babys 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 infants 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 Positivenegative 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 T33 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 30 mm with a slice gap of 03 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 232 ms TI 900 ms flip angle 8 deg 192 sagittal slices of thickness 09 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 infantother infantscrambled 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 infants 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 multiple regression models will examine the main effect of experimental group expressed as a dummy-coded variable indicating MBCP participation on self-report measures of presence and compassionate love at post-class and postnatal times controlling for baseline measures These models will demonstrate whether MBCP results in increased levels of these qualities both more generally and specifically with the mothers own infant
In addition hierarchical linear modeling HLM will be used to compare MBCP and control mothers slopes on each measure available across all three assessments This will offer a more nuanced longitudinal test of how prenatal mindfulness training may impact the development of mindful presence and compassion not specific to ones infant from pregnancy through the first postpartum months
Aim 2 MBCP neural response to ones infant To test Hypothesis 2 that MBCP mothers will show increased neural activation to their infants emotion cues in brain regions supporting the above qualities-ie 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 26 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 andor 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 history of birth complications or losses distress and practice dosage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19461 | OTHER | University of Illinois | None |