MOM Program 8-Year Follow-up

This study has been completed.
Sponsor:
Collaborator:
William Penn Foundation
Information provided by (Responsible Party):
Jerilynn Radcliffe, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00970853
First received: September 2, 2009
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Child Development
Behavioral: MOM Program home visiting
Other: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The MOM Program Continuation - 8 Year Follow-up

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog) [ Time Frame: 8 years post original enrollment in study ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading [ Time Frame: 8 years from study entry ] [ Designated as safety issue: No ]
    The WJR-III, Ach, Broad Reading measures reading achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Broad Reading was selected because it includes indices of reading and a recent standardization sample that 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).

  • Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math [ Time Frame: 8 years from study entry ] [ Designated as safety issue: No ]
    The WJR-III, Ach, Broad Math measures math academic achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Math was selected because 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).

  • Child Behavior Checklist (CBCL), Internalizing [ Time Frame: 8 years from study entry ] [ Designated as safety issue: No ]
    The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are then derived with a mean of 50 and a standard deviation of 10. Worst value is 80; best value is 30.

  • Child Behavior Checklist (CBCL), Externalizing [ Time Frame: 8 years from study entry ] [ Designated as safety issue: No ]
    The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. The worst possible score is 80 and the best possible score is 30.

  • Child Behavior Checklist (CBCL),Total Problems [ Time Frame: 8 years from study entry ] [ Designated as safety issue: No ]
    The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Worst score is 80; best score is 30.

  • Teacher Rating Form (TRF), Internalizing [ Time Frame: 8 years from study entry ] [ Designated as safety issue: No ]
    The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with scores from age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. value is 80; best value is 30.

  • Teacher Rating Form (TRF), Externalizing [ Time Frame: 8 years from study entry ] [ Designated as safety issue: No ]
    The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80.

  • Teacher Rating Form (TRF), Total Problems [ Time Frame: 8 years from study entry ] [ Designated as safety issue: No ]
    The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80.


Enrollment: 187
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Control group
Other: Control
Control group will receive same assessment batteries at follow-up but did not receive the home visiting program.
Experimental: MOM Program home visiting
Mixed professional support home visiting program.
Behavioral: MOM Program home visiting
Mixed professional home visiting program.

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.

  Eligibility

Ages Eligible for Study:   94 Months to 98 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970853

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
William Penn Foundation
Investigators
Principal Investigator: Jerilynn Radcliffe, PhD Children's Hospital of Philadelphia
  More Information

No publications provided by Children's Hospital of Philadelphia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jerilynn Radcliffe, PI, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00970853     History of Changes
Other Study ID Numbers: 09-007041, WPF-228-08
Study First Received: September 2, 2009
Results First Received: December 7, 2011
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Evaluate developmental outcomes
Evaluate child cognitive, academic, and behavioral outcomes

ClinicalTrials.gov processed this record on July 22, 2014