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The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of Philadelphia

The MOM Program Continuation - 5 Year Follow-up

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00231179
Acronym
MOM Program
Enrollment
302
Registered
2005-10-04
Start date
2004-02-29
Completion date
2007-02-28
Last updated
2015-11-23

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

Conditions

Child Development

Keywords

child, preschool, intelligence, environment, home visiting

Brief summary

The purpose of the MOM Program Continuation is to promote child development by helping families become more competent in accessing and using available health, developmental and educational resources. The program focuses are childhood immunizations, Early Intervention services, lead screening, Early Head Start and Head Start enrollment. The Intervention consists of frequent phone calls and home visits to encourage mothers to have their babies immunized on schedule and to participate in needed developmental and educational services. The program seeks to fill the gap between children's need for services and mothers' ability to assure their children's participation in those services.

Detailed description

The MOM Program Continuation builds on the work of The MOM Program, a 3 year randomized intervention. The premise of the MOM Program was that professional support through home visits and frequent phone contacts would improve children's cognitive and behavioral development, ultimately improving their early educational success. The children were enrolled in the MOM Program at birth. The MOM Program Continuation provides continued intervention for the children and mothers of the original cohort to assure that the children are prepared for kindergarten entry at 5 years of age and to evaluate the children's cognitive and behavioral outcomes at age 5 years. The program will also create a longitudinal database to study the linkages between maternal cognitive ability and child cognitive, educational, and behavioral outcomes through entry into school.

Interventions

BEHAVIORALHome visiting professional support model

Home visits and telephone calls keyed to well child visits.

OTHERControl

The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information

Sponsors

William Penn Foundation
CollaboratorOTHER
Claneil Foundation, Inc.
CollaboratorOTHER
Robert Wood Johnson Foundation
CollaboratorOTHER
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

Previous enrollment in The MOM Program; child age of 5 years (plus or minus 3 months); willingness to come to office for follow-up assessment visit; parental consent and child assent.

Exclusion criteria

None.

Design outcomes

Primary

MeasureTime frameDescription
Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)5 years of age (plus or minus 1 month)Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III). The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age. The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score. These scores have a mean of 100 and a standard deviation of 15. The range of possible values is 50 (worst value) to 150 (best value).
Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participantsat child age of 5 years (plus or minus 1 month)Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participantsat child age of 5 years (plus or minus 1 month)Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participantsat child age of 5 years (plus or minus 1 month)Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participantschild age 5 years (plus or minus 1 month)Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).

Countries

United States

Participant flow

Recruitment details

Participants were recruited from the Hospital of the University of Pennsylvania after giving birth to a healthy singleton newborn infant, if they lived in pre-identified ZIP Code areas of Philadelphia. Participants were recruited from July 6, 2001 through January 7, 2002. 302 mothers were enrolled and 254 completed the 5-year follow-up visit.

Pre-assignment details

Randomization occurred at enrollment. At the time of follow-up, participants continued to remain in the originally assigned group of either control or intervention.

Participants by arm

ArmCount
Home Visiting Intervention
The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
152
Control
The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
150
Total302

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up2121
Overall StudyWithdrawal by Subject33

Baseline characteristics

CharacteristicHome Visiting InterventionControlTotal
Age, Customized
4-5 years
152 participants150 participants302 participants
Region of Enrollment
United States
152 participants150 participants302 participants
Sex: Female, Male
Female
81 Participants82 Participants163 Participants
Sex: Female, Male
Male
71 Participants68 Participants139 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1520 / 150
serious
Total, serious adverse events
0 / 1520 / 150

Outcome results

Primary

Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants

Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).

Time frame: at child age of 5 years (plus or minus 1 month)

ArmMeasureValue (NUMBER)
Home Visiting InterventionChild Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants4 Percentage of participants
ControlChild Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants12 Percentage of participants
p-value: <0.05Chi-squared
Primary

Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants

Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).

Time frame: child age 5 years (plus or minus 1 month)

ArmMeasureValue (NUMBER)
Home Visiting InterventionChild Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants7 Percentage of participants
ControlChild Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants8 Percentage of participants
p-value: 0.64Chi-squared
Primary

Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants

Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).

Time frame: at child age of 5 years (plus or minus 1 month)

ArmMeasureValue (NUMBER)
Home Visiting InterventionChild Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants3 percentage of participants
ControlChild Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants12 percentage of participants
p-value: <0.01Chi-squared
Primary

Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants

Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).

Time frame: at child age of 5 years (plus or minus 1 month)

Population: Number of mothers/caregivers evaluated at 60 month visit.

ArmMeasureValue (NUMBER)Dispersion
Home Visiting InterventionChild Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants8 percentage of participants 8.9
ControlChild Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants11 percentage of participants 11.2
p-value: 0.72Chi-squared
Primary

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)

Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III). The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age. The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score. These scores have a mean of 100 and a standard deviation of 15. The range of possible values is 50 (worst value) to 150 (best value).

Time frame: 5 years of age (plus or minus 1 month)

Population: Number of children evaluated at 60 month visit.

ArmMeasureValue (MEAN)Dispersion
Home Visiting InterventionWechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)86.5 Scores on a scaleStandard Deviation 12.6
ControlWechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)87.4 Scores on a scaleStandard Deviation 12.2
Comparison: We compared scores for verbal, performance, and full scale Intelligence Quotient (IQ).p-value: 0.5995% CI: [0.31, 2.13]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026