- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00970853
MOM Program 8-Year Follow-up
March 20, 2014 updated by: Jerilynn Radcliffe, Children's Hospital of Philadelphia
The MOM Program Continuation - 8 Year Follow-up
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
187
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 8 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control
Control group
|
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.
|
Mixed professional home visiting program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
8 years post original enrollment in study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
8 years from study entry
|
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).
|
8 years from study entry
|
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.
|
8 years from study entry
|
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.
|
8 years from study entry
|
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.
|
8 years from study entry
|
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.
|
8 years from study entry
|
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 years from study entry
|
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.
|
8 years from study entry
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (ACTUAL)
May 1, 2011
Study Completion (ACTUAL)
May 1, 2011
Study Registration Dates
First Submitted
September 2, 2009
First Submitted That Met QC Criteria
September 2, 2009
First Posted (ESTIMATE)
September 3, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 15, 2014
Last Update Submitted That Met QC Criteria
March 20, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 09-007041
- WPF-228-08 (OTHER_GRANT: The William Penn Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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