The MOM Program at the Children's Hospital of Philadelphia

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. Identifier: NCT00230555
Recruitment Status : Completed
First Posted : October 3, 2005
Last Update Posted : October 3, 2005
Information provided by:
Children's Hospital of Philadelphia

Brief Summary:
The purpose of the MOM Program is to promote child development by helping families become more competent in accessing and using available resources. The program focuses are childhood immunizations, Early Intervention services, lead screening, Early Head Start and Head Start enrollment. The hypothsis is that children receiving the intervention will participate in more of the public services and primary healthcare activities which have been shown to be effective in improving their development.

Condition or disease Intervention/treatment Phase
Child Development Behavioral: professional support model Phase 3

Detailed Description:
The MOM Program is a 3 year randomized controlled trial of mothers and newborns. At enrollment subjects are given a questionnaire to assess self efficacy and a non-verbal test of intelligence. Program personnel are blind to the results of this testing. Test results will be used in data analysis at the end of the study to compare outcomes of the intervention and control groups and to assess how mothers with impaired cognitive ability have benefited from participation in the study.The Intervention consists of frequent phone calls and home visits to encourage mothers to have their babies immunized on schedule and to participate in needed developmental and educational services. At 33 months of age all children receive a developmental assessment.

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The MOM Program at the Children's Hospital of Philadelphia
Study Start Date : July 2001
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. child intelligence, 33 months of age

Secondary Outcome Measures :
  1. At child age 33 months: maternal intelligence
  2. At child age 33 months:caregiver depression
  3. At child age 33 months: childhood immunization completion At child age 33 months: Early Intervention usage

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria: mothers from West and South Philadelphia who have given birth on the post-partum unit at the Hospital of the University of Pennsylvania during the six month enrollment period from July, 2001 to Jan, 2002..

Exclusion Criteria: women or infants who are critically ill, those involving multiple births (ie twins), and women who are solely non-English speaking.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00230555

United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Principal Investigator: Donald F Schwarz, M.D. Children's Hospital of Philadelphia Identifier: NCT00230555     History of Changes
Other Study ID Numbers: 2001-4-2388
First Posted: October 3, 2005    Key Record Dates
Last Update Posted: October 3, 2005
Last Verified: April 2005

Keywords provided by Children's Hospital of Philadelphia:
child, preschool