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Trial Outcomes & Findings for MOM Program 8-Year Follow-up (NCT NCT00970853)

NCT ID: NCT00970853

Last Updated: 2014-04-15

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

187 participants

Primary outcome timeframe

8 years post original enrollment in study

Results posted on

2014-04-15

Participant Flow

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.

Participant milestones

Participant milestones
Measure
Control
Control group
MOM Program Home Visiting
Mixed professional support home visiting program.
Overall Study
STARTED
89
98
Overall Study
COMPLETED
89
98
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MOM Program 8-Year Follow-up

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=89 Participants
Control group
MOM Program Home Visiting
n=98 Participants
Mixed professional support home visiting program.
Total
n=187 Participants
Total of all reporting groups
Age, Categorical
<=18 years
89 Participants
n=93 Participants
98 Participants
n=4 Participants
187 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Continuous
7.96 years
STANDARD_DEVIATION .12 • n=93 Participants
7.95 years
STANDARD_DEVIATION .13 • n=4 Participants
7.95 years
STANDARD_DEVIATION .12 • n=27 Participants
Sex: Female, Male
Female
51 Participants
n=93 Participants
47 Participants
n=4 Participants
98 Participants
n=27 Participants
Sex: Female, Male
Male
38 Participants
n=93 Participants
51 Participants
n=4 Participants
89 Participants
n=27 Participants
Region of Enrollment
United States
89 participants
n=93 Participants
98 participants
n=4 Participants
187 participants
n=27 Participants

PRIMARY outcome

Timeframe: 8 years post original enrollment in study

Population: All were included.

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).

Outcome measures

Outcome measures
Measure
Control
n=89 Participants
Control group
MOM Program Home Visiting
n=98 Participants
Mixed professional support home visiting program.
Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)
89.32 units on a scale
Standard Deviation 12.32
87.62 units on a scale
Standard Deviation 14.08

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Control
n=89 Participants
Control group
MOM Program Home Visiting
n=98 Participants
Mixed professional support home visiting program.
Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading
90.92 units on a scale
Standard Deviation 17.19
90.94 units on a scale
Standard Deviation 16.33

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Control
n=89 Participants
Control group
MOM Program Home Visiting
n=98 Participants
Mixed professional support home visiting program.
Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math
94.30 units on a scale
Standard Deviation 16.37
90.80 units on a scale
Standard Deviation 16.83

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Control
n=89 Participants
Control group
MOM Program Home Visiting
n=98 Participants
Mixed professional support home visiting program.
Child Behavior Checklist (CBCL), Internalizing
50.30 units on a scale
Standard Deviation 8.85
49.16 units on a scale
Standard Deviation 9.61

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Control
n=89 Participants
Control group
MOM Program Home Visiting
n=98 Participants
Mixed professional support home visiting program.
Child Behavior Checklist (CBCL), Externalizing
54.02 units on a scale
Standard Deviation 10.76
53.12 units on a scale
Standard Deviation 10.34

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Control
n=89 Participants
Control group
MOM Program Home Visiting
n=98 Participants
Mixed professional support home visiting program.
Child Behavior Checklist (CBCL),Total Problems
53.22 units on a scale
Standard Deviation 10.20
51.81 units on a scale
Standard Deviation 10.00

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Control
n=89 Participants
Control group
MOM Program Home Visiting
n=98 Participants
Mixed professional support home visiting program.
Teacher Rating Form (TRF), Internalizing
48.85 units on a scale
Standard Deviation 9.63
49.21 units on a scale
Standard Deviation 11.45

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Control
n=89 Participants
Control group
MOM Program Home Visiting
n=98 Participants
Mixed professional support home visiting program.
Teacher Rating Form (TRF), Externalizing
55.75 units on a scale
Standard Deviation 9.86
54.78 units on a scale
Standard Deviation 11.73

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Control
n=89 Participants
Control group
MOM Program Home Visiting
n=98 Participants
Mixed professional support home visiting program.
Teacher Rating Form (TRF), Total Problems
53.80 units on a scale
Standard Deviation 10.17
52.94 units on a scale
Standard Deviation 12.69

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MOM Program Home Visiting

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jerilynn Radcliffe

Children's Hospital of Philadelphia

Phone: 215-590-7446

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place