MedPath

Legacy for Children, an Early Intervention Study to Promote Optimal Child Development in Low-income Families

Not Applicable
Completed
Conditions
Child Development
Interventions
Behavioral: Parenting group
Registration Number
NCT00164697
Lead Sponsor
Centers for Disease Control and Prevention
Brief Summary

The purpose of this study is to determine if an intervention focused on promoting parent-child interaction, parental responsibility, parental commitment of time and energy, and sense of community results in better developmental outcomes for low-income children.

Detailed Description

The early years of life (birth to age 5 years) are crucial in a child's development. Parents play a critical role in their children's development and are responsible for the environment in which they grow up. Past research shows that the personal characteristics of successful children consistently correlate to parental influences and behavior. Thus, the theoretical foundation in the Legacy study is that parents can positively influence their child's development. Also, parents are more likely to maintain positive parenting behaviors if they are part of a community greater than themselves. Legacy intervention activities are designed to enhance sensitive and responsive parenting, parent/child interaction, and promote a sense of community. Other activities include verbal and cognitive stimulation through parent and parent/child group meetings, visits to the home, and participation in community events. Legacy has both a pilot phase and a main study phase. There are 180 intervention and 120 comparison families in the main study phase and 60 of each in the pilot phase at each study site, Miami and Los Angeles. The 720 participating families are those whose children, on average, would be expected to fall below national norms on a range of developmental outcomes. Process, cost, and short- and long-term outcome data are being collected.

Comparison group: In addition to the current standard of care, the comparison families receive regular comprehensive child development and maternal assessments at 6 months, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
547
Inclusion Criteria
  • English speaking
  • Live within 10 miles of UCLA
  • 18 years of age or older
  • Receive their prenatal and well-baby care from MediCal
  • Live within 50 minutes of the three community intervention sites
  • Reside within zip codes corresponding to the lowest performing schools in the broad Miami area
  • Give birth to the target child at participating hospitals
Exclusion Criteria
  • Multiple birth greater than twins
  • Existing Substance abuse
  • Existing Mental Health issues

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Parenting groupParenting group
Primary Outcome Measures
NameTimeMethod
child attachment2 yr
child social skills1yr, 2 yr, 3 yr, 4 yr, 5 yr
child academics4 yr, 5 yr
parent-child interaction6 months, 5 yr
child behavior1yr, 2 yr, 3 yr, 4 yr, 5 yr
child peer relationships5 yr
child cognition1 yr, 3 yr, 5 yr
child language/communication2 yr, 4 yr, 5 yr
Secondary Outcome Measures
NameTimeMethod
sense of communitybaseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
parentingbaseline, 6 mos, 2 yr, 3 yr 5 yr
child physical growthbaseline, 6 month, 1 yr, 2 yr
child violence exposure2 yr, 4 yr, 5 yr
maternal healthbaseline, 1 yr 3 yr, 5 yr
community involvementbaseline, 6 mos, 2yr, 3yr, 5 yr
coping6mos, 2yr, 3 yr, 5 yr
maternal mental healthbaseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
HOME environment1 yr

Trial Locations

Locations (2)

University of Miami School of Medicine

🇺🇸

MIami, Florida, United States

UCLA Department of Pediatrics

🇺🇸

Los Angeles, California, United States

© Copyright 2025. All Rights Reserved by MedPath