MOM Program 8-Year Follow-up

• ClinicalTrials.gov Identifier: NCT00970853
• Recruitment Status: Completed
• First Posted: September 3, 2009
• Results First Posted: March 21, 2014
• Last Update Posted: April 15, 2014
• Sponsor: Children's Hospital of Philadelphia
• Collaborator: William Penn Foundation
• Information provided by (Responsible Party): Jerilynn Radcliffe, Children's Hospital of Philadelphia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Child Development	Behavioral: MOM Program home visiting; Other: Control	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 187 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The MOM Program Continuation - 8 Year Follow-up
• Study Start Date: March 2009
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading [ Time Frame: 8 years from study entry ]
   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).
2. Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math [ Time Frame: 8 years from study entry ]
   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).
3. Child Behavior Checklist (CBCL), Internalizing [ Time Frame: 8 years from study entry ]
   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.
4. Child Behavior Checklist (CBCL), Externalizing [ Time Frame: 8 years from study entry ]
   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.
5. Child Behavior Checklist (CBCL),Total Problems [ Time Frame: 8 years from study entry ]
   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.
6. Teacher Rating Form (TRF), Internalizing [ Time Frame: 8 years from study entry ]
   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.
7. Teacher Rating Form (TRF), Externalizing [ Time Frame: 8 years from study entry ]
   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.
8. Teacher Rating Form (TRF), Total Problems [ Time Frame: 8 years from study entry ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 94 Months to 98 Months (Child)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Radcliffe J, Schwarz D, Zhao H; MOM Program. The MOM Program: home visiting in partnership with pediatric care. Pediatrics. 2013 Nov;132 Suppl 2:S153-9. doi: 10.1542/peds.2013-1021O.

• Responsible Party: Jerilynn Radcliffe, PI, Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT00970853
• Other Study ID Numbers: 09-007041; WPF-228-08 ( Other Grant/Funding Number: The William Penn Foundation )
• First Posted: September 3, 2009
• Results First Posted: March 21, 2014
• Last Update Posted: April 15, 2014
• Last Verified: March 2014

Keywords provided by Jerilynn Radcliffe, Children's Hospital of Philadelphia:

Evaluate developmental outcomes; Evaluate child cognitive, academic, and behavioral outcomes