Clinical trial NCT02856711: Assessing the CenteringPregnancy Planning to Parent Innovation
Official title: Assessing the CenteringPregnancy Planning to Parent Innovation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychologic
Pregnancy
Keywords: Group Prenatal Visits,CenteringPregnancy
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2016-08-05
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators propose to evaluate how the CenteringPregnancy curriculum compared with an enhanced curriculum, with the addition of 2 trauma-informed interventions, affects how new parents prepare for parenting and respond to common stressors.

Detailed description: The two interventions will be 1) A viewing of "All Babies Cry" and a discussion of what it's like to be a new parent and 2) A "Planning to Parent" stress activity where parents discuss when they have felt overwhelmed, the coping mechanisms they used, and what can be done to manage those emotions in the future. The goal of this project is to gain insight from current participants in CenteringPregnancy group care around the ways that these interventions can better prepare parents to deal with the common stresses of parenthood.

The investigators will assess the curriculum by administering pre-test and post-test surveys to CenteringPregancy patients within 6 groups. Three of the groups will use the regular CenteringPregnancy curriculum and 3 of the groups will use the enhanced Centering Pregnancy curriculum. Participants will be recruited to CenteringPregnancy, and thus this study, as part of Boston Medical Center Obstetrics/Gynecology Associate's regular prenatal registration process and will be assigned to prenatal groups based on due date. The informed consent and pre-test will be administered to patients at Session 7 of the CenteringPregnancy curriculum and the post-test will be administered to patients at the postpartum visit. The control CenteringPregnancy groups will follow the regular curriculum as written in the CenteringPregnancy Facilitator's Guide. The experimental CenteringPregnancy groups will follow the regular CenteringPregnancy curriculum, with the addition of the "All Babies Cry" intervention during Session 7 (30-34 weeks) and the "Planning to Parent" stress intervention during Session 8 (32-36 weeks). There will be no individual interviews of participants. Following the postpartum survey, the Research Assistant will conduct electronic medical record chart reviews of the study participants.

The investigators propose to seek between 24 and 36 patients for the 3 control groups and between 24 and 36 patients for the 3 experimental groups, for a total of 48-72 subjects. Pre-test and post-test surveys will be collected by a member of the research team. Surveys will be kept in a locked desk and will later analyzed. The intent of this study is to gather important information on ways to improve group-based prenatal care from a patient-centered, trauma-informed perspective. This will ultimately help to improve both family and child well being and reduce the risk of child abuse, neglect and parental and toxic stress in the greater Boston area.

Eligibility criteria: Inclusion Criteria:

* Fluent in English language. Able to complete a written survey in English.
* Currently participating in CenteringPregnancy groups at Boston Medical Center.
* A woman at least 18 years old or older.

Exclusion Criteria:

* Women who do not attend the sessions where the intervention are conducted
* Women \<18 years old will not be recruited. All participants will be 18 years old or older.
* Not fluent in English language.

Primary outcomes:
measure: Sources of parenting information
timeFrame: 1 month postpartum
measure: Types of parenting support used
timeFrame: 1 month postpartum
measure: Types of parental behaviors demonstrated
timeFrame: 1 month postpartum
measure: Frequency of depressed moods (scale)
timeFrame: 1 month postpartum
measure: Parents' levels of social support
timeFrame: 1 month postpartum
measure: Frequency of parenting stress (scale)
timeFrame: 1 month postpartum
Secondary outcomes:
Other outcomes:
measure: Gestational age at first prenatal visit
timeFrame: 1 month postpartum
measure: Number of prenatal visits
timeFrame: 1 month postpartum
measure: Gestational age at delivery
timeFrame: 1 month postpartum
measure: Birth weight
timeFrame: 1 month postpartum
measure: Delivery Mode
timeFrame: 1 month postpartum
measure: Neonatal intensive care unit admission
timeFrame: 1 month postpartum
measure: Breastfeeding rate (scale)
timeFrame: 1 month postpartum
measure: Body mass index
timeFrame: 1 month postpartum
measure: Contraceptive plan
timeFrame: 1 month postpartum
measure: Contraceptive method used
timeFrame: 1 month postpartum
measure: Sexually transmitted disease exposure
timeFrame: 1 month postpartum
measure: Tobacco use
timeFrame: 1 month postpartum
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Beth Monahan
role: PRINCIPAL_INVESTIGATOR
References: