Integrating Well-Woman and Well-Baby Care to Improve Parenting and Family Wellness

We hypothesize that relative to families who receive standard individual postpartum and pediatric care, families that receive group care will be more likely to have:

• Improved maternal and child health behaviors: i.e increased breastfeeding, exercise, child safety measures in the home and decreased smoking.
• Better health care use for babies: i.e. attend more care visits, on-time and complete immunizations and decreased emergency services use.
• Better psychosocial outcomes for the families: i.e. decreased stress and depression, and increased social support.
• Improved parenting skills: i.e. improved knowledge of child development, involvement in developmentally appropriate activities, and parental sense of competence.

Study Overview

• Status: Unknown
• Conditions: Primary Care
• Intervention / Treatment: Other: Standard Care; Other: Centering parenting/Group well child care

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Postpartum woman with baby in her care
• Receive well-woman care, well-child care and interviews in English
• Willingness to receive care in a group setting
• Woman planning to receive care at the Yale Women's Center for herself and the Primary Care Center for her baby

Exclusion Criteria:

• severe medical problem requiring individualized care for mother or baby
• Baby born at less than 37 weeks gestation
• Baby remaining in hospital when mother getting discharged for any other reason except hyperbilirubinemia
• Baby with severe cardiac, respiratory, neuro-developmental or surgical problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; No intervention consists of routine well child care	Other: Standard Care
Other: Centering parenting/Group well child care	Other: Centering parenting/Group well child care; Intervention families will receive well child care in a group format for the first 12 month of the child's life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improved maternal and child health behaviors will be measured using a computer assisted interview.	Interviews will be given at 2 weeks, 6 and 12 months of age.

Secondary Outcome Measures

Outcome Measure	Time Frame
Better health care utilization for babies will be measured using Medical records review.	1 year
Better psychosocial outcomes for mothers, fathers and babies will be measured using a computer assisted interview.	2 weeks, 6 months and 12 months of age
Improved parenting skills will be assessed using a computer assisted inteview.	2 weeks, 6 months ad 12 months

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): May 1, 2010
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: October 28, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (Estimate): October 29, 2008

Study Record Updates

• Last Update Posted (Estimate): October 29, 2008
• Last Update Submitted That Met QC Criteria: October 28, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: primary care, high-risk families, maternal depression
• Other Study ID Numbers: R21 HDJ2810-01A1