The MOM Program at the Children's Hospital of Philadelphia

• Sponsor: Children's Hospital of Philadelphia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00230555
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Duration (Months): 40
• Patients Per Site Per Month: 7.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Jul 1, 2001
• Study Completion Date: Nov 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 3 Days
• 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..

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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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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Children's Hospital of Philadelphia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00230555
• Other Study ID Numbers: 2001-4-2388
• First Posted: Oct 3, 2005
• Last Update Posted: Oct 3, 2005
• Last Verified: Apr 1, 2005

• Keywords provided by , ,: child, preschool; environment; intelligence

Study Results

No Results Posted as of Oct 3, 2005