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Completed

NCT Number: NCT02856711

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trauma-informed group

Behavioral

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 outcomes

  1. Sources of parenting information

    Time frame: 1 month postpartum

  2. Types of parenting support used

    Time frame: 1 month postpartum

  3. Types of parental behaviors demonstrated

    Time frame: 1 month postpartum

  4. Frequency of depressed moods (scale)

    Time frame: 1 month postpartum

  5. Parents' levels of social support

    Time frame: 1 month postpartum

  6. Frequency of parenting stress (scale)

    Time frame: 1 month postpartum

Other outcomes

  1. Gestational age at first prenatal visit

    Time frame: 1 month postpartum

  2. Number of prenatal visits

    Time frame: 1 month postpartum

  3. Gestational age at delivery

    Time frame: 1 month postpartum

  4. Birth weight

    Time frame: 1 month postpartum

  5. Delivery Mode

    Time frame: 1 month postpartum

  6. Neonatal intensive care unit admission

    Time frame: 1 month postpartum

  7. Breastfeeding rate (scale)

    Time frame: 1 month postpartum

  8. Body mass index

    Time frame: 1 month postpartum

  9. Contraceptive plan

    Time frame: 1 month postpartum

  10. Contraceptive method used

    Time frame: 1 month postpartum

  11. Sexually transmitted disease exposure

    Time frame: 1 month postpartum

  12. Tobacco use

    Time frame: 1 month postpartum

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Doris Duke Charitable Foundation

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2016
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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