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Clinical Trials/NCT00970853
NCT00970853
Completed
Phase 3

The MOM Program Continuation - 8 Year Follow-up

Children's Hospital of Philadelphia1 site in 1 country187 target enrollmentMarch 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Child Development
Sponsor
Children's Hospital of Philadelphia
Enrollment
187
Locations
1
Primary Endpoint
Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Study measures will evaluate cognitive, academic, and behavioral outcomes for the children, school services received, and caregiver stress and depression. The main study outcome measures include cognitive status, school functioning, and behavior. Long-term outcomes will be studied in attempt to verify the 33 and 60 month significant differences found in school participation and behavior between the intervention and control groups.

Detailed Description

This study examines 8-year follow-up results from The MOM Program, a randomized controlled trial (RCT) of a mixed professional home visiting program to promote positive developmental outcomes among children in poverty. The earlier study found significant differences in both school participation and behavior among the intervention group at ages 33 and 60 months of age. Families from the original MOM Program RCT that provide informed consent will be eligible for the study when the children are 8 years of age.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
May 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jerilynn Radcliffe

PI

Children's Hospital of Philadelphia

Eligibility Criteria

Inclusion Criteria

  • Families from the original MOM RCT that participated in the 60 month evaluation
  • Able to return to Philadelphia area for testing
  • Parental/guardian informed consent and child assent

Exclusion Criteria

  • Children unable to complete testing due to sensory, physical, or other deficits, as determined by clinical review by study psychologist
  • Caregivers unwilling to authorize the release of school information
  • Non-English speaking

Outcomes

Primary Outcomes

Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)

Time Frame: 8 years post original enrollment in study

The WJR-III, Cog measures intelligence and cognition in children and offers a recent standardization sample and updated item content. The WJR-III, Cog was selected because it includes verbal, nonverbal, and language scales and its recent standardization sample includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families.The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).

Secondary Outcomes

  • Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading(8 years from study entry)
  • Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math(8 years from study entry)
  • Child Behavior Checklist (CBCL), Internalizing(8 years from study entry)
  • Child Behavior Checklist (CBCL), Externalizing(8 years from study entry)
  • Child Behavior Checklist (CBCL),Total Problems(8 years from study entry)
  • Teacher Rating Form (TRF), Internalizing(8 years from study entry)
  • Teacher Rating Form (TRF), Externalizing(8 years from study entry)
  • Teacher Rating Form (TRF), Total Problems(8 years from study entry)

Study Sites (1)

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