Assessing the CenteringPregnancy Planning to Parent Innovation

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Stress, Psychologic
• Intervention / Treatment: Behavioral: Trauma-informed group

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trauma-informed group; These groups will use the enhanced Centering Pregnancy curriculum.	Behavioral: Trauma-informed group; 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, 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.
No Intervention: Control group; These groups will use the standard CenteringPregnancy curriculum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sources of parenting information	1 month postpartum
Types of parenting support used	1 month postpartum
Types of parental behaviors demonstrated	1 month postpartum
Frequency of depressed moods (scale)	1 month postpartum
Parents' levels of social support	1 month postpartum
Frequency of parenting stress (scale)	1 month postpartum

Other Outcome Measures

Outcome Measure	Time Frame
Gestational age at first prenatal visit	1 month postpartum
Number of prenatal visits	1 month postpartum
Gestational age at delivery	1 month postpartum
Birth weight	1 month postpartum
Delivery Mode	1 month postpartum
Neonatal intensive care unit admission	1 month postpartum
Breastfeeding rate (scale)	1 month postpartum
Body mass index	1 month postpartum
Contraceptive plan	1 month postpartum
Contraceptive method used	1 month postpartum
Sexually transmitted disease exposure	1 month postpartum
Tobacco use	1 month postpartum

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Doris Duke Charitable Foundation
• Investigators: Principal Investigator: Beth Monahan, Boston Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Group Prenatal Visits,CenteringPregnancy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: H-34199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided