Assessing the CenteringPregnancy Planning to Parent Innovation
Primary Purpose
Stress, Psychologic, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-informed group
Sponsored by
About this trial
This is an interventional health services research trial for Stress, Psychologic focused on measuring Group Prenatal Visits,CenteringPregnancy
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.
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Trauma-informed group
Control group
Arm Description
These groups will use the enhanced Centering Pregnancy curriculum.
These groups will use the standard CenteringPregnancy curriculum.
Outcomes
Primary Outcome Measures
Sources of parenting information
Types of parenting support used
Types of parental behaviors demonstrated
Frequency of depressed moods (scale)
Parents' levels of social support
Frequency of parenting stress (scale)
Secondary Outcome Measures
Full Information
NCT ID
NCT02856711
First Posted
April 25, 2016
Last Updated
November 22, 2016
Sponsor
Boston Medical Center
Collaborators
Doris Duke Charitable Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02856711
Brief Title
Assessing the CenteringPregnancy Planning to Parent Innovation
Official Title
Assessing the CenteringPregnancy Planning to Parent Innovation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
Doris Duke Charitable Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychologic, Pregnancy
Keywords
Group Prenatal Visits,CenteringPregnancy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trauma-informed group
Arm Type
Experimental
Arm Description
These groups will use the enhanced Centering Pregnancy curriculum.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
These groups will use the standard CenteringPregnancy curriculum.
Intervention Type
Behavioral
Intervention Name(s)
Trauma-informed group
Intervention 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, 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.
Primary Outcome Measure Information:
Title
Sources of parenting information
Time Frame
1 month postpartum
Title
Types of parenting support used
Time Frame
1 month postpartum
Title
Types of parental behaviors demonstrated
Time Frame
1 month postpartum
Title
Frequency of depressed moods (scale)
Time Frame
1 month postpartum
Title
Parents' levels of social support
Time Frame
1 month postpartum
Title
Frequency of parenting stress (scale)
Time Frame
1 month postpartum
Other Pre-specified Outcome Measures:
Title
Gestational age at first prenatal visit
Time Frame
1 month postpartum
Title
Number of prenatal visits
Time Frame
1 month postpartum
Title
Gestational age at delivery
Time Frame
1 month postpartum
Title
Birth weight
Time Frame
1 month postpartum
Title
Delivery Mode
Time Frame
1 month postpartum
Title
Neonatal intensive care unit admission
Time Frame
1 month postpartum
Title
Breastfeeding rate (scale)
Time Frame
1 month postpartum
Title
Body mass index
Time Frame
1 month postpartum
Title
Contraceptive plan
Time Frame
1 month postpartum
Title
Contraceptive method used
Time Frame
1 month postpartum
Title
Sexually transmitted disease exposure
Time Frame
1 month postpartum
Title
Tobacco use
Time Frame
1 month postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Monahan
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Assessing the CenteringPregnancy Planning to Parent Innovation
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