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

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Overall Status: Unknown status
• CT.gov ID: NCT00782028
• Collaborator: (none)
• Enrollment: 170
• Arms: 2
• Duration (Months): 19

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Primary Care	Other: Centering parenting/Group well child care; Other: Standard Care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 170 participants
• 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
• Study Start Date: Oct 1, 2008
• Anticipated Primary Completion Date: May 1, 2010
• Anticipated Study Completion Date: May 1, 2010

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Better health care utilization for babies will be measured using Medical records review. [1 year]

2. 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]

3. Improved parenting skills will be assessed using a computer assisted inteview. [2 weeks, 6 months ad 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00782028
• Other Study ID Numbers: R21 HDJ2810-01A1
• First Posted: Oct 29, 2008
• Last Update Posted: Oct 29, 2008
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: primary care, high-risk families, maternal depression

Study Results

No Results Posted as of Oct 29, 2008