A Phase 3 interventional study of MOM Program home visiting and Control in Child Development, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 94 Months to 98 Months. Per ClinicalTrials.gov, last updated 2014-04-15.
Sponsored by Children's Hospital of Philadelphia · Phase 3, Interventional, and Prevention
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.
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.
Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Control group
Other: Control
Mixed professional support home visiting program.
Behavioral: MOM Program home visiting
Mixed professional home visiting program.
Control group will receive same assessment batteries at follow-up but did not receive the home visiting program.
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).
Time frame: 8 years post original enrollment in study
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 years from study entry
Mothers from high poverty areas with singleton healthy infants weighing at least 2500g with no genetic or developmental disorders were recruited from post-partum unit of an academic hospital. At child age 8-years mothers were contacted for an in office follow-up visit. 187 of 253 eligible mothers participated.
| Milestone | Control | MOM Program Home Visiting |
|---|---|---|
| Started | 89 | 98 |
| Completed | 89 | 98 |
| Not completed | 0 | 0 |
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).
| units on a scale | Control | MOM Program Home Visiting |
|---|---|---|
| Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog) | 89.32 ± 12.32 | 87.62 ± 14.08 |
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).
| units on a scale | Control | MOM Program Home Visiting |
|---|---|---|
| Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading | 90.92 ± 17.19 | 90.94 ± 16.33 |
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).
| units on a scale | Control | MOM Program Home Visiting |
|---|---|---|
| Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math | 94.30 ± 16.37 | 90.80 ± 16.83 |
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.
| units on a scale | Control | MOM Program Home Visiting |
|---|---|---|
| Child Behavior Checklist (CBCL), Internalizing | 50.30 ± 8.85 | 49.16 ± 9.61 |
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.
| units on a scale | Control | MOM Program Home Visiting |
|---|---|---|
| Child Behavior Checklist (CBCL), Externalizing | 54.02 ± 10.76 | 53.12 ± 10.34 |
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.
| units on a scale | Control | MOM Program Home Visiting |
|---|---|---|
| Child Behavior Checklist (CBCL),Total Problems | 53.22 ± 10.20 | 51.81 ± 10.00 |
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.
| units on a scale | Control | MOM Program Home Visiting |
|---|---|---|
| Teacher Rating Form (TRF), Internalizing | 48.85 ± 9.63 | 49.21 ± 11.45 |
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.
| units on a scale | Control | MOM Program Home Visiting |
|---|---|---|
| Teacher Rating Form (TRF), Externalizing | 55.75 ± 9.86 | 54.78 ± 11.73 |
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.
| units on a scale | Control | MOM Program Home Visiting |
|---|---|---|
| Teacher Rating Form (TRF), Total Problems | 53.80 ± 10.17 | 52.94 ± 12.69 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | 0/89 (0%) | 0/89 (0%) |
| MOM Program Home Visiting | — | 0/98 (0%) | 0/98 (0%) |
| Age, Categorical(Participants) | Control | MOM Program Home Visiting | Total |
|---|---|---|---|
| <=18 years | 89 | 98 | 187 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Control | MOM Program Home Visiting | Total |
|---|---|---|---|
| Mean | 7.96 ± .12 | 7.95 ± .13 | 7.95 ± .12 |
| Sex: Female, Male(Participants) | Control | MOM Program Home Visiting | Total |
|---|---|---|---|
| Female | 51 | 47 | 98 |
| Male | 38 | 51 | 89 |
| Region of Enrollment(participants) | Control | MOM Program Home Visiting | Total |
|---|---|---|---|
| United States | 89 | 98 | 187 |
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital of Philadelphia