A Phase 3 interventional study of Home visiting professional support model and Control in Child Development, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 4 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-23.
Sponsored by Children's Hospital of Philadelphia · Phase 3, Interventional, and Prevention
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.
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.
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.
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.
Home visiting intervention group.
Behavioral: Home visiting professional support model
Control condition did not receive any services.
Other: Control
Home visits and telephone calls keyed to well child visits.
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
Also known as: No intervention, informational booklet only
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)
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)
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)
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)
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)
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.
| Milestone | Home Visiting Intervention | Control |
|---|---|---|
| Started | 152 | 150 |
| Completed | 128 | 126 |
| Not completed | 24 | 24 |
| Withdrew: Lost to follow-up | 21 | 21 |
| Withdrew: Withdrawal by subject | 3 | 3 |
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).
| Scores on a scale | Home Visiting Intervention | Control |
|---|---|---|
| Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III) | 86.5 ± 12.6 | 87.4 ± 12.2 |
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).
| percentage of participants | Home Visiting Intervention | Control |
|---|---|---|
| Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants | 8 ± 8.9 | 11 ± 11.2 |
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).
| percentage of participants | Home Visiting Intervention | Control |
|---|---|---|
| Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants | 3 | 12 |
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).
| Percentage of participants | Home Visiting Intervention | Control |
|---|---|---|
| Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants | 4 | 12 |
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).
| Percentage of participants | Home Visiting Intervention | Control |
|---|---|---|
| Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants | 7 | 8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Home Visiting Intervention | — | 0/152 (0%) | 0/152 (0%) |
| Control | — | 0/150 (0%) | 0/150 (0%) |
| Age, Customized(participants) | Home Visiting Intervention | Control | Total |
|---|---|---|---|
| 4-5 years | 152 | 150 | 302 |
| Sex: Female, Male(Participants) | Home Visiting Intervention | Control | Total |
|---|---|---|---|
| Female | 81 | 82 | 163 |
| Male | 71 | 68 | 139 |
| Region of Enrollment(participants) | Home Visiting Intervention | Control | Total |
|---|---|---|---|
| United States | 152 | 150 | 302 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia