## Protocol Section
### Identification Module
**NCT ID:** NCT00231179

**Acronym:** MOM Program

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

**Official Title:** The MOM Program Continuation - 5 Year Follow-up

#### Organization Study ID Info
**ID:** 2003-10-3495
#### Organization
**Class:** OTHER
**Full Name:** Children's Hospital of Philadelphia
### Status Module
#### Completion Date
**Date:** 2007-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-11-23

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-10-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2010-07-02

**Type:** ESTIMATED

**Results First Submit Date:** 2010-03-01

**Results First Submit QC Date:** 2010-06-01

#### Start Date
**Date:** 2004-02

**Status Verified Date:** 2015-10

#### Study First Post Date
**Date:** 2005-10-04
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-30
**Study First Submit QC Date:** 2005-09-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** William Penn Foundation

**Class:** OTHER

**Name:** Claneil Foundation, Inc.

**Class:** OTHER

**Name:** Robert Wood Johnson Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** Children's Hospital of Philadelphia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Child Development

**Keywords:**

- child, preschool

- intelligence

- environment

- home visiting

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 302

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Home visiting intervention group.

**Intervention Names:**

- Behavioral: Home visiting professional support model

**Label:** Home visiting Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Control condition did not receive any services.

**Intervention Names:**

- Other: Control

**Label:** Control

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Home visiting Intervention

**Description:** Home visits and telephone calls keyed to well child visits.

**Name:** Home visiting professional support model

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** 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

**Name:** Control

**Other Names:**

- No intervention, informational booklet only

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

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

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

**Description:** 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).

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

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

**Description:** 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).

**Measure:** Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants

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

**Description:** 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).

**Measure:** Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants

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

**Description:** 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).

**Measure:** Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants

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

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 5 Years

**Minimum Age:** 4 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Philadelphia

**Country:** United States

**Facility:** The Children's Hospital of Philadelphia

**State:** Pennsylvania

**Zip:** 19104

#### Overall Officials

**Official 1:**

**Affiliation:** Children's Hospital of Philadelphia

**Name:** Jerilynn Radcliffe, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Home Visiting Intervention

**Description:** 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.

**ID:** EG000

**Other Num at Risk:** 152

**Serious Number At Risk:** 152

**Title:** Home Visiting Intervention

**Group ID:** EG001

**Title:** Control

**Description:** 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.

**ID:** EG001

**Other Num at Risk:** 150

**Serious Number At Risk:** 150

**Title:** Control

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 152

**Group ID:** BG001

**Value:** 150

**Group ID:** BG002

**Value:** 302

**Units:** Participants

### Group

**ID:** BG000

**Title:** Home Visiting Intervention

**Description:** 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.

### Group

**ID:** BG001

**Title:** Control

**Description:** 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.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 152

#### Measurement

**Group ID:** BG001

**Value:** 150

#### Measurement

**Group ID:** BG002

**Value:** 302

**Class Title:** 4-5 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 81

#### Measurement

**Group ID:** BG001

**Value:** 82

#### Measurement

**Group ID:** BG002

**Value:** 163

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 71

#### Measurement

**Group ID:** BG001

**Value:** 68

#### Measurement

**Group ID:** BG002

**Value:** 139

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 152

#### Measurement

**Group ID:** BG001

**Value:** 150

#### Measurement

**Group ID:** BG002

**Value:** 302

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** NUMBER
**Title:** Age, Customized
**Unit of Measure:** participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** The initial high rate of refusal to participate in the study may affect the generalizability of our results. Those who refused study participation were older and did not elaborate on their lack of interest.
### Point of Contact
**Email:** Radcliffe@email.chop.edu
**Organization:** Children's Hospital of Philadelphia
**Phone:** 215-590-7446
**Title:** Jerilynn Radcliffe, PhD
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.31
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.13
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_DEVIATION
**Dispersion Value:** 15.0
**Estimate Comment:** 
**Group Description:** We compared scores for verbal, performance, and full scale Intelligence Quotient (IQ).
**Non-Inferiority Comment:** Sample sizes were established when the trial was first developed. For all power calculations, we set alpha = .05 and beta = .20 and specified 2-tailed tests.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.59
**P-Value Comment:** Bonferroni corrections were made for multiple comparisons.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.81
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** True
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 5
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Please see earlier power calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.72
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 10
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** True
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 5
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** See previous.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** <0.01
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 10
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** True
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 3
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** See previous.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** <0.05
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 3
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** True
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 3
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** See previous.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.64
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 3
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** True
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.6
- **Upper Limit:** 
- **Value:** 86.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12.2
- **Upper Limit:** 
- **Value:** 87.4
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.9
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 11.2
- **Upper Limit:** 
- **Value:** 11
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Number of children evaluated at 60 month visit.
**Reporting Status:** POSTED
**Time Frame:** 5 years of age (plus or minus 1 month)
**Title:** Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)
**Type:** PRIMARY
**Unit of Measure:** Scores on a scale
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Home Visiting Intervention
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Control
#### Outcome Measure 2
**Description:** 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).
**Parameter Type:** NUMBER
**Population Description:** Number of mothers/caregivers evaluated at 60 month visit.
**Reporting Status:** POSTED
**Time Frame:** at child age of 5 years (plus or minus 1 month)
**Title:** Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Home Visiting Intervention
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Control
#### Outcome Measure 3
**Description:** 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).
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** at child age of 5 years (plus or minus 1 month)
**Title:** Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Home Visiting Intervention
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Control
#### Outcome Measure 4
**Description:** 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).
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** at child age of 5 years (plus or minus 1 month)
**Title:** Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants
**Type:** PRIMARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Home Visiting Intervention
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Control
#### Outcome Measure 5
**Description:** 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).
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** child age 5 years (plus or minus 1 month)
**Title:** Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants
**Type:** PRIMARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Home Visiting Intervention
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Control
### Participant Flow Module
#### Group
**Description:** 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.
**ID:** FG000
**Title:** Home Visiting Intervention
#### Group
**Description:** 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.
**ID:** FG001
**Title:** Control
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 21
###### Reason
**Group ID:** FG001
**Number of Subjects:** 21
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 152
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 150
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 128
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 126
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 24
**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.
**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.
**Has Results:** True