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

Official Title: “Legacy for Children, The CDC Parenting Research Projects”

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.

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.

Intervention(s) in this Clinical Trial

• Behavioral: Parenting group
  • Weekly and periodic (10 weeks blocks with 6 week break) parenting group meetings (2.5-3 hr), periodic one-on-one meetings (2 hr), visits to community resources (2-3 hr per event). 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Parenting group

Primary Measures

• child behavior
  • Time Frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr
    Safety Issue?: No
• child social skills
  • Time Frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr
    Safety Issue?: No
• child cognition
  • Time Frame: 1 yr, 3 yr, 5 yr
    Safety Issue?: No
• child language/communication
  • Time Frame: 2 yr, 4 yr, 5 yr
    Safety Issue?: No
• child attachment
  • Time Frame: 2 yr
    Safety Issue?: No
• child peer relationships
  • Time Frame: 5 yr
    Safety Issue?: No
• child academics
  • Time Frame: 4 yr, 5 yr
    Safety Issue?: No
• parent-child interaction
  • Time Frame: 6 months, 5 yr
    Safety Issue?: No

Secondary Measures

• child physical growth
  • Time Frame: baseline, 6 month, 1 yr, 2 yr
    Safety Issue?: No
• child violence exposure
  • Time Frame: 2 yr, 4 yr, 5 yr
    Safety Issue?: No
• parenting
  • Time Frame: baseline, 6 mos, 2 yr, 3 yr 5 yr
    Safety Issue?: No
• maternal health
  • Time Frame: baseline, 1 yr 3 yr, 5 yr
    Safety Issue?: No
• maternal mental health
  • Time Frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
    Safety Issue?: No
• sense of community
  • Time Frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
    Safety Issue?: No
• community involvement
  • Time Frame: baseline, 6 mos, 2yr, 3yr, 5 yr
    Safety Issue?: No
• coping
  • Time Frame: 6mos, 2yr, 3 yr, 5 yr
    Safety Issue?: No
• HOME environment
  • Time Frame: 1 yr
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Centers for Disease Control and Prevention U.S. Fed

Overall Clinical Trial Officials and Contacts

Ruth Perou, PhD Principal Investigator Centers for Disease Control and Prevention  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00164697

Study ID Number: CDC-NCBDDD-2524

ClinicalTrials.gov Identifier: NCT00164697

Health Authority: United States: Federal Government

Click here for information about this study: Legacy for Children