Childbirth Education Pilot Study

NCT ID: NCT04327557

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-02
• Study Completion Date: 2027-11-30

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.

Conditions

Pregnancy; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MBCP Childbirth Education Course

This arm will undergo the 9-week MBCP course.

Group Type: EXPERIMENTAL

MBCP Childbirth Education Course

Intervention Type: BEHAVIORAL

The MBCP program is a fully manualized childbirth and parenting preparation course. Developed in 1998 in a clinical context, MBCP is an enhanced version of the Mindfulness Based Stress Reduction (MBSR) program tailored for addressing the concerns of pregnancy and early parenting. Through MBCP, pregnant women and their partners learn mindfulness skills for coping with the anxiety and stress of pregnancy and parenting, and the pain and fear of childbirth. They are given explicit instruction in skills for cultivating positive emotion and developing mindful, sensitive parenting. MBCP groups meet weekly for 9 weeks, with a retreat day between weeks 6 and 7.

Non-MBCP Childbirth Education Course

This arm will undergo the TAU (treatment as usual) childbirth education course (one that does not have a huge mindfulness component).

Group Type: ACTIVE_COMPARATOR

Non-MBCP Childbirth Education Course

Intervention Type: BEHAVIORAL

TAU control participants will undergo standard (real-world) hospital- or community-based childbirth education that does not have a mindfulness focus. They will be able to choose whichever class they want from the list. If they prefer a class that is not on the list, then study staff will obtain the syllabus for that class to check whether there is a mindfulness component.

Interventions

MBCP Childbirth Education Course

The MBCP program is a fully manualized childbirth and parenting preparation course. Developed in 1998 in a clinical context, MBCP is an enhanced version of the Mindfulness Based Stress Reduction (MBSR) program tailored for addressing the concerns of pregnancy and early parenting. Through MBCP, pregnant women and their partners learn mindfulness skills for coping with the anxiety and stress of pregnancy and parenting, and the pain and fear of childbirth. They are given explicit instruction in skills for cultivating positive emotion and developing mindful, sensitive parenting. MBCP groups meet weekly for 9 weeks, with a retreat day between weeks 6 and 7.

Intervention Type: BEHAVIORAL

Non-MBCP Childbirth Education Course

TAU control participants will undergo standard (real-world) hospital- or community-based childbirth education that does not have a mindfulness focus. They will be able to choose whichever class they want from the list. If they prefer a class that is not on the list, then study staff will obtain the syllabus for that class to check whether there is a mindfulness component.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Born to a mother participating in the study

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larissa Duncan, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Healthy Minds

Sarah Short, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Healthy Minds

Locations

University of Wisconsin Madison

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

A271000

Identifier Type: OTHER

Identifier Source: secondary_id

SOHE/GENERAL ADMINISTRATION

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 2/3/2020

Identifier Type: OTHER

Identifier Source: secondary_id

2018-1575

Identifier Type: -

Identifier Source: org_study_id