MOM Program 8-Year Follow-up

The MOM Program Continuation - 8 Year Follow-up

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00970853

Enrollment

187

Registered

2009-09-03

Start date

2009-03-31

Completion date

2011-05-31

Last updated

2014-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

Keywords

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

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.

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.

Interventions

BEHAVIORALMOM Program home visiting

Mixed professional home visiting program.

OTHERControl

Control group will receive same assessment batteries at follow-up but did not receive the home visiting program.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

94 Months to 98 Months

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame	Description
Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math	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).
Child Behavior Checklist (CBCL), Internalizing	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.
Child Behavior Checklist (CBCL), Externalizing	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.
Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading	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).
Teacher Rating Form (TRF), Internalizing	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.
Teacher Rating Form (TRF), Externalizing	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.
Teacher Rating Form (TRF), Total Problems	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.
Child Behavior Checklist (CBCL),Total Problems	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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
Control Control group	89
MOM Program Home Visiting Mixed professional support home visiting program.	98
Total	187

Baseline characteristics

Characteristic	MOM Program Home Visiting	Control	Total
Age, Categorical <=18 years	98 Participants	89 Participants	187 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	7.95 years STANDARD_DEVIATION 0.13	7.96 years STANDARD_DEVIATION 0.12	7.95 years STANDARD_DEVIATION 0.12
Region of Enrollment United States	98 participants	89 participants	187 participants
Sex: Female, Male Female	47 Participants	51 Participants	98 Participants
Sex: Female, Male Male	51 Participants	38 Participants	89 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 89	0 / 98
serious Total, serious adverse events	0 / 89	0 / 98

Outcome results

Primary

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

Population: All were included.

Arm	Measure	Value (MEAN)	Dispersion
Control	Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)	89.32 units on a scale	Standard Deviation 12.32
MOM Program Home Visiting	Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)	87.62 units on a scale	Standard Deviation 14.08

p-value: 0.39t-test, 2 sided

Secondary

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.