NCT00782028

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Status
unknown

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

October 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 29, 2008

Status Verified

October 1, 2008

Enrollment Period

1.6 years

First QC Date

October 28, 2008

Last Update Submit

October 28, 2008

Conditions

Keywords

primary care, high-risk families, maternal depression

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • 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

Study Arms (2)

Standard Care

NO INTERVENTION

No intervention consists of routine well child care

Other: Standard Care

Centering parenting/Group well child care

OTHER
Other: Centering parenting/Group well child care

Interventions

Intervention families will receive well child care in a group format for the first 12 month of the child's life.

Centering parenting/Group well child care
Standard Care

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 29, 2008

Study Start

October 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 29, 2008

Record last verified: 2008-10