The MOM Program at the Children's Hospital of Philadelphia

Child Development Clinical Trial

Official title:

The MOM Program at the Children's Hospital of Philadelphia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230555
• Other study ID #: 2001-4-2388
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2005
• Last updated: September 29, 2005
• Start date: July 2001
• Est. completion date: November 2004

Study information

• Verified date: April 2005
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Development

Intervention

Behavioral:
• professional support model

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	child intelligence, 33 months of age
Secondary	At child age 33 months: maternal intelligence
Secondary	At child age 33 months:caregiver depression
Secondary	At child age 33 months: childhood immunization completion At child age 33 months: Early Intervention usage