Assessing the CenteringPregnancy Planning to Parent Innovation

Pregnancy Clinical Trial

Official title:

Assessing the CenteringPregnancy Planning to Parent Innovation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856711
• Other study ID #: H-34199
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: November 22, 2016
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pregnancy
• Stress, Psychologic
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gestational age at first prenatal visit		1 month postpartum	No
Other	Number of prenatal visits		1 month postpartum	No
Other	Gestational age at delivery		1 month postpartum	No
Other	Birth weight		1 month postpartum	No
Other	Delivery Mode		1 month postpartum	No
Other	Neonatal intensive care unit admission		1 month postpartum	No
Other	Breastfeeding rate (scale)		1 month postpartum	No
Other	Body mass index		1 month postpartum	No
Other	Contraceptive plan		1 month postpartum	No
Other	Contraceptive method used		1 month postpartum	No
Other	Sexually transmitted disease exposure		1 month postpartum	No
Other	Tobacco use		1 month postpartum	No
Primary	Sources of parenting information		1 month postpartum	No
Primary	Types of parenting support used		1 month postpartum	No
Primary	Types of parental behaviors demonstrated		1 month postpartum	No
Primary	Frequency of depressed moods (scale)		1 month postpartum	No
Primary	Parents' levels of social support		1 month postpartum	No
Primary	Frequency of parenting stress (scale)		1 month postpartum	No