Clinical trial NCT04327557: Childbirth Education Pilot Study
Official title: Pilot Study on Effectiveness of Childbirth Education
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pregnancy
Anxiety
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to either MBCP childbirth education course or a non-MBCP childbirth course to look at effects of different types of childbirth education.
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effects of mindfulness training on prenatal maternal anxiety using a randomized controlled trial (RCT). An RCT of mindfulness training for prenatal anxiety has distinct clinical and scientific advantages.

The investigators will use the Mindfulness-Based Childbirth and Parenting (MBCP) intervention in this study to build on previous findings by focusing on anxiety in pregnancy while also teaching mindfulness skills shown to promote positive childbirth appraisals and sensitive parenting through mindful parenting skills that have been shown to be linked to maternal-infant stress physiology in other work.

This study will enroll pregnant women with elevated anxiety (N = 60) who will be randomly assigned to the MBCP condition (n = 30) or an active control condition (a treatment as usual (TAU) condition; n = 30) which is a standard childbirth education class. Mothers will be assessed pre- and post-intervention and postpartum. Infant multi-modal neuroimaging will occur at age 1 month, at home questionnaire follow-up will occur at age 3 months, and a behavioral observation of parenting and child social-emotional functioning will occur at age 12 months. The hypothesis is that there will be greater benefits from MBCP relative to TAU controls, and enhanced connectivity between the amygdala and relevant cortico-limbic areas in from MBCP relative to TAU controls.

Detailed description: Baseline (Pre-Class) Visit : Once study eligibility has been confirmed, the participant will come to the lab for an in-person visit. If they choose to continue in the study after reading and signing the consent form, they will complete a series of questionnaires and collect saliva samples at home.

Childbirth Education Intervention: The participant will be randomly assigned to one of two childbirth and parenting education groups (either the MBCP course offered at UW Health or a TAU course). Participants in the TAU group will be provided options of courses to select. Courses may last up to 9 weeks long. The course is provided as part of the study. Participants are asked to complete the course before the 37th week of pregnancy.

Post-Intervention (Post-Class) Visit: After completing the childbirth and parenting education course, the participant will complete a series of questionnaires and collect another set of saliva samples. This can happen in person or remotely.

1-Month Follow-Up Visit: One month after birth, the participant and their child will come to the lab for an MRI scan of the child's brain while he or she sleeps as well as complete another series of questionnaires.

3-Month Follow-Up Visit: Three months after birth, the participant will complete a series of questionnaires.

12-Month Follow-Up Visit: Twelve months after birth, the participant and their child will come to the lab for one final visit to do a behavioral assessment as well as complete a final series of questionnaires.

Eligibility criteria: Maternal Inclusion Criteria:

* A score on the Penn State Worry Questionnaire (PSWQ) of 50 or greater
* Nulliparous and expecting a healthy (i.e., normal/low medical risk), singleton pregnancy
* No more than 28 weeks gestation at time of enrollment (to allow time to complete the intervention before 37 weeks)
* Comfortable reading, writing, and conversing in English.
* Available and able to enroll in the MBCP class

Infant Inclusion Criteria:

* Born to a mother participating in the study

Maternal Exclusion Criteria:

* Severe medical conditions that would compromise the pregnancy (e.g., pre-eclampsia, severe hyperthyroidism);
* Current or past bipolar disorder, schizophrenia, or post-traumatic stress disorder (PTSD);
* Active psychopharmacological treatment (current or in the past 6 months).
* Formal mindfulness meditation practice or long-term yoga practice
* Significant injuries, illness or surgery that may impair parent-child interaction (e.g., traumatic brain injury) or that is unstably treated.
* HIV or AIDS
* Cancer in the past year
* Major Autoimmune Disease
* Infection while pregnant such as Toxoplasmosis, Rubella, Cytomegalovirus (CMV) infection, Herpes Simplex Virus (HSV), Syphilis
* Prior childbirth

Infant Exclusion Criteria:

* Major neurosensory impairment: legally blind or coloboma
* Isoimmunization
* Severe jaundice
* Facial cleft
* Abnormal heart rate: ECG \>180 or \<80

Primary outcomes:
measure: Maternal Stress Physiology as Measured by Change in Slope for Salivary Cortisol from Pre-Class to Post-Class Phase
timeFrame: At pre-class and post-class phases approximately within a 12 week window
measure: Change in Anxiety Levels as Measured by the State Trait Anxiety Inventory-X2 (STAI-X2)
timeFrame: Up to 12 months post birth
measure: Change in Depression Levels as Measured by the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Up to 12 months post birth
measure: Change in Depression Levels as Measured by the Center for Epidemiologic Studies Depression (CESD) Scale
timeFrame: Up to 12 months post birth
measure: Change in Positive and Negative Emotions as Measured by the Positive And Negative Affect Scale (PANAS)
timeFrame: Up to 12 months post birth
measure: Emotional State as Measured by the Differential Emotions Scale (DES)
timeFrame: Up to 12 months post birth
measure: Change in Mindfulness Levels as Measured by the Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Up to 12 months post birth
measure: Change in Worry Levels as Measured by the Penn State Worry Questionnaire (PSWQ)
timeFrame: Up to 12 months post birth
measure: Infant Emotion Regulation as Measured by the Infant Behavior Questionnaire-Revised (IBQ-R)
timeFrame: At 3 month and 12 month post birth
measure: Change in Parenting Stress Levels as Measured by the Parenting Stress Index-Short Form (PSI-SF)
timeFrame: At 1 month, 3 month and 12 month post birth
measure: Change in Parenting Competence Levels as Measured by the Parenting Sense of Competence Scale (PSC)
timeFrame: At 1 month, 3 month and 12 month post birth
measure: Change in Compassion Levels as Measured by the Compassion Scale (CS)
timeFrame: Up to 12 months post birth
measure: Change in Self-Compassion Levels as Measured by the Self-Compassion Scale-Short Form (SCS-SF)
timeFrame: Up to 12 months post birth
measure: Change in Antenatal Attachment Levels as Measured by the Maternal Antenatal Attachment Scale (MAAS)
timeFrame: At pre-class and post-class phases approximately within a 12 week window
measure: Change in Postnatal Attachment Levels as Measured by the Maternal Postnatal Attachment Scale (MPAS)
timeFrame: At 1 month, 3 month and 12 month post birth
measure: Change in Parental Mindfulness Levels as Measured by the Interpersonal Mindfulness in Parenting (IM-P) Questionnaire
timeFrame: At 1 month, 3 month and 12 month post birth
measure: Physical Activity Levels as Measured by the International Physical Activity Questionnaire-Long (IPAQ-Long)
timeFrame: At 1 month, 3 month and 12 month post birth
measure: Change in Sleep Quality Levels as Measured by the General Sleep Disturbance Scale (GSDS)
timeFrame: Up to 12 months post birth
measure: Pregnancy Substance Use as Measured by Retrospective Substance Use (RSU)
timeFrame: At post-class phase within a 1 week window
measure: Change in Relationship Strength Levels as Measured by the Perceived Relationship Quality Components Inventory (PRQC)
timeFrame: Up to 12 months post birth
measure: Change in Quality of Life as Measured by the EQ-5D5L Questionnaire
timeFrame: Up to 12 months post birth
Secondary outcomes:
measure: Infant Enjoyment and Mother-Infant Attachment Differences as Measured by the Puppet Task (Lab-TAB Task)
timeFrame: At 12 months post birth
measure: Infant Anger and Mother-Infant Attachment Differences as Measured by the Arm Restraint Task (Lab-TAB Task)
timeFrame: At 12 months post birth
measure: Infant Pleasure and Mother-Infant Attachment Differences as Measured by the Peek-A-Boo Task (Lab-TAB Task)
timeFrame: At 12 months post birth
measure: Emotion Regulation and Mother-Infant Attachment Differences as Measured by the Strange Situation
timeFrame: At 12 months post birth
measure: Brain Structure and Functional Connectivity Differences as Measured by Magnetic Resonance Imaging (MRI) Scans
timeFrame: At 1 month post birth
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
Study officials:
affiliation: Center for Healthy Minds
name: Larissa Duncan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Healthy Minds
name: Sarah Short, PhD
role: PRINCIPAL_INVESTIGATOR
References: