Trial Outcomes & Findings for The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of Philadelphia (NCT NCT00231179)
NCT ID: NCT00231179
Last Updated: 2015-11-23
Results Overview
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).
COMPLETED
PHASE3
302 participants
5 years of age (plus or minus 1 month)
2015-11-23
Participant Flow
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.
Randomization occurred at enrollment. At the time of follow-up, participants continued to remain in the originally assigned group of either control or intervention.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
150
|
|
Overall Study
COMPLETED
|
128
|
126
|
|
Overall Study
NOT COMPLETED
|
24
|
24
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
21
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of Philadelphia
Baseline characteristics by cohort
| Measure |
Home Visiting Intervention
n=152 Participants
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.
|
Control
n=150 Participants
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.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
4-5 years
|
152 participants
n=5 Participants
|
150 participants
n=7 Participants
|
302 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
152 participants
n=5 Participants
|
150 participants
n=7 Participants
|
302 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 years of age (plus or minus 1 month)Population: Number of children evaluated at 60 month visit.
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).
Outcome measures
| Measure |
Home Visiting Intervention
n=128 Participants
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.
|
Control
n=126 Participants
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.
|
|---|---|---|
|
Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)
|
86.5 Scores on a scale
Standard Deviation 12.6
|
87.4 Scores on a scale
Standard Deviation 12.2
|
PRIMARY outcome
Timeframe: at child age of 5 years (plus or minus 1 month)Population: Number of mothers/caregivers evaluated at 60 month visit.
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).
Outcome measures
| Measure |
Home Visiting Intervention
n=128 Participants
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.
|
Control
n=126 Participants
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.
|
|---|---|---|
|
Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants
|
8 percentage of participants
8.9
|
11 percentage of participants
11.2
|
PRIMARY outcome
Timeframe: at 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).
Outcome measures
| Measure |
Home Visiting Intervention
n=128 Participants
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.
|
Control
n=126 Participants
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.
|
|---|---|---|
|
Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants
|
3 percentage of participants
|
12 percentage of participants
|
PRIMARY outcome
Timeframe: at 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).
Outcome measures
| Measure |
Home Visiting Intervention
n=128 Participants
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.
|
Control
n=126 Participants
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.
|
|---|---|---|
|
Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants
|
4 Percentage of participants
|
12 Percentage of participants
|
PRIMARY outcome
Timeframe: child 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).
Outcome measures
| Measure |
Home Visiting Intervention
n=128 Participants
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.
|
Control
n=126 Participants
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.
|
|---|---|---|
|
Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants
|
7 Percentage of participants
|
8 Percentage of participants
|
Adverse Events
Home Visiting Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jerilynn Radcliffe, PhD
Children's Hospital of Philadelphia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place