NCT02856711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

April 25, 2016

Last Update Submit

November 22, 2016

Conditions

Keywords

Group Prenatal Visits,CenteringPregnancy

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (12)

  • Gestational age at first prenatal visit

    1 month postpartum

  • Number of prenatal visits

    1 month postpartum

  • Gestational age at delivery

    1 month postpartum

  • +9 more other outcomes

Study Arms (2)

Trauma-informed group

EXPERIMENTAL

These groups will use the enhanced Centering Pregnancy curriculum.

Behavioral: Trauma-informed group

Control group

NO INTERVENTION

These groups will use the standard CenteringPregnancy curriculum.

Interventions

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.

Trauma-informed group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Beth Monahan

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Outreach & Evaluation Coordinator, Vital Village Network, General Pediatrics

Study Record Dates

First Submitted

April 25, 2016

First Posted

August 5, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations