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

Centers for Disease Control and Prevention (CDC)

Status: Completed

Conditions: Child Development

Treatments: Behavioral: Parenting group

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00164697

200-98-0111

200-98-0110

CDC-NCBDDD-2524

200-94-0828

Details and patient eligibility

About

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.

Full 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.

Enrollment: 547 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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547 participants in 2 patient groups

1

Experimental group

Description:

Parenting group

Treatment:

Behavioral: Parenting group

2

No Intervention group

Description:

Families in this "usual care" comparison group were not prevented from utilizing any service that would otherwise be available to them, even if the service was similar to the services received in the intervention arm of the study.