The MOM Program at the Children's Hospital of Philadelphia

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.

Study Overview

• Status: Completed
• Conditions: Child Development
• Intervention / Treatment: Behavioral: professional support model

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
• Enrollment: 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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..

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
child intelligence, 33 months of age

Secondary Outcome Measures

Outcome Measure
At child age 33 months: maternal intelligence
At child age 33 months:caregiver depression
At child age 33 months: childhood immunization completion At child age 33 months: Early Intervention usage

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Donald F Schwarz, M.D., Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Study Completion: November 1, 2004

Study Registration Dates

• First Submitted: September 29, 2005
• First Submitted That Met QC Criteria: September 29, 2005
• First Posted (Estimate): October 3, 2005

Study Record Updates

• Last Update Posted (Estimate): October 3, 2005
• Last Update Submitted That Met QC Criteria: September 29, 2005
• Last Verified: April 1, 2005

More Information

Terms related to this study

• Keywords: environment; child, preschool; intelligence
• Other Study ID Numbers: 2001-4-2388