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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00782028
First received: October 28, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.

Condition Intervention
Primary Care
 Other: Centering parenting/Group well child care
Other: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Integrating Well-Woman and Well-Baby Care to Improve Parenting and Family Wellness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Improved maternal and child health behaviors will be measured using a computer assisted interview. [ Time Frame: Interviews will be given at 2 weeks, 6 and 12 months of age. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Better health care utilization for babies will be measured using Medical records review. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Better psychosocial outcomes for mothers, fathers and babies will be measured using a computer assisted interview. [ Time Frame: 2 weeks, 6 months and 12 months of age ] [ Designated as safety issue: No ]
  • Improved parenting skills will be assessed using a computer assisted inteview. [ Time Frame: 2 weeks, 6 months ad 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: October 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Care
No intervention consists of routine well child care
 Other: Standard Care
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: John M. Leventhal, MD, Department of Pediatrics
ClinicalTrials.gov Identifier: NCT00782028     History of Changes
Other Study ID Numbers: R21 HDJ2810-01A1
Study First Received: October 28, 2008
Last Updated: October 28, 2008
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
primary care, high-risk families, maternal depression

ClinicalTrials.gov processed this record on May 19, 2013