Coping With it All From Labor to Maternity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Five Facet Mindfulness Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •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
结局指标
主要结局
Five Facet Mindfulness Questionnaire
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
- Parenting Stress Index - Short Form(Time 3 (3 months postnatal))
- Self-Compassion Scale(Time 2 (37 weeks pregnancy))
- Positive and Negative Affect Scale(Time 3 (3 months postnatal))
研究者
Heidemarie Laurent
Associate Professor of Human Development and Family Studies
Penn State University