MOM Program 8-Year Follow-up

Study Overview
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Brief Summary
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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
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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.

Official Title
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The MOM Program Continuation - 8 Year Follow-up

Conditions
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Child Development

Intervention / Treatment
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* Behavioral: MOM Program home visiting
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 94 Months
Maximum Age: 98 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Control group | Other: Control<br>* Control group will receive same assessment batteries at follow-up but did not receive the home visiting program.<br>|
| Experimental: MOM Program home visiting<br>Mixed professional support home visiting program. | Behavioral: MOM Program home visiting<br>* Mixed professional home visiting program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Evaluate developmental outcomes, Evaluate child cognitive, academic, and behavioral outcomes