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

NCT00231179 | Completed Phase 3 Results

• 1 other identifier: 2003-10-3495
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development

Keywords

child, preschool; intelligence; environment; home visiting

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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).

  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).

  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).

  child age 5 years (plus or minus 1 month)

Study Arms (2)

Home visiting Intervention

EXPERIMENTAL

Home visiting intervention group.

Behavioral: Home visiting professional support model

Control

PLACEBO COMPARATOR

Control condition did not receive any services.

Other: Control

Interventions

Home visiting professional support model BEHAVIORAL

Home visits and telephone calls keyed to well child visits.

Home visiting Intervention

Control OTHER

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

Control

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• William Penn Foundation: collaborator
• Claneil Foundation, Inc.: collaborator
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Jerilynn Radcliffe, PhD
• Organization: Children's Hospital of Philadelphia

Radcliffe@email.chop.edu

215-590-7446

Study Officials

• Jerilynn Radcliffe, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: February 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: November 23, 2015
• Results First Posted: July 2, 2010

Record last verified: 2015-10

Locations

US (1)