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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. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00782028
First Posted: October 29, 2008
Last Update Posted: October 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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. ]

Secondary Outcome Measures:
  • Better health care utilization for babies will be measured using Medical records review. [ Time Frame: 1 year ]
  • 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 ]
  • Improved parenting skills will be assessed using a computer assisted inteview. [ Time Frame: 2 weeks, 6 months ad 12 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Responsible Party: John M. Leventhal, MD, Department of Pediatrics
ClinicalTrials.gov Identifier: NCT00782028     History of Changes
Other Study ID Numbers: R21 HDJ2810-01A1
First Submitted: October 28, 2008
First Posted: October 29, 2008
Last Update Posted: October 29, 2008
Last Verified: October 2008

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