This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborators:
RTI International
University of California, Los Angeles
University of Miami
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164697
First received: September 13, 2005
Last updated: February 2, 2016
Last verified: September 2012
September 13, 2005
February 2, 2016
October 1999
February 2013   (Final data collection date for primary outcome measure)
  • child behavior [ Time Frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr ]
  • child social skills [ Time Frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr ]
  • child cognition [ Time Frame: 1 yr, 3 yr, 5 yr ]
  • child language/communication [ Time Frame: 2 yr, 4 yr, 5 yr ]
  • child attachment [ Time Frame: 2 yr ]
  • child peer relationships [ Time Frame: 5 yr ]
  • child academics [ Time Frame: 4 yr, 5 yr ]
  • parent-child interaction [ Time Frame: 6 months, 5 yr ]
  • child behavior 1yr, 2 yr, 3 yr, 4 yr, 5 yr
  • child social skills 1yr, 2 yr, 3 yr, 4 yr, 5 yr
  • child cognition 1 yr, 3 yr, 5 yr
  • child language/communication 2 yr, 4 yr, 5 yr
  • child attachment 2 yr
  • child peer relationships 5 yr
  • child academics 4 yr, 5 yr
  • parent-child interaction 6 months, 5 yr
Complete list of historical versions of study NCT00164697 on ClinicalTrials.gov Archive Site
  • child physical growth [ Time Frame: baseline, 6 month, 1 yr, 2 yr ]
  • child violence exposure [ Time Frame: 2 yr, 4 yr, 5 yr ]
  • parenting [ Time Frame: baseline, 6 mos, 2 yr, 3 yr 5 yr ]
  • maternal health [ Time Frame: baseline, 1 yr 3 yr, 5 yr ]
  • maternal mental health [ Time Frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr ]
  • sense of community [ Time Frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr ]
  • community involvement [ Time Frame: baseline, 6 mos, 2yr, 3yr, 5 yr ]
  • coping [ Time Frame: 6mos, 2yr, 3 yr, 5 yr ]
  • HOME environment [ Time Frame: 1 yr ]
  • child physical growth baseline, 6 month, 1 yr, 2 yr
  • child blood lead 3 yr
  • child hemoglobin 3 yr
  • child violence exposure 2 yr, 4 yr, 5 yr
  • parenting baseline, 6 mos, 2 yr, 3 yr 5 yr
  • maternal health baseline, 1 yr 3 yr, 5 yr
  • maternal mental health baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
  • sense of community baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
  • community involvement baseline, 6 mos, 2yr, 3yr, 5 yr
  • coping 6mos, 2yr, 3 yr, 5 yr
  • HOME environment 1 yr
Not Provided
Not Provided
 
Legacy for Children, an Early Intervention Study to Promote Optimal Child Development in Low-income Families
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Child Development
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.
Other Name: Behavioral
  • Experimental: 1
    Parenting group
    Intervention: Behavioral: Parenting group
  • No Intervention: 2
    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.
Perou R, Elliott MN, Visser SN, Claussen AH, Scott KG, Beckwith LH, Howard J, Katz LF, Smith DC. Legacy for ChildrenTM: a pair of randomized controlled trials of a public health model to improve developmental outcomes among children in poverty. BMC Public Health. 2012 Aug 23;12:691. doi: 10.1186/1471-2458-12-691.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
547
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00164697
CDC-NCBDDD-2524
200-94-0828
200-98-0110
200-98-0111
No
Not Provided
No
Not Provided
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
  • RTI International
  • University of California, Los Angeles
  • University of Miami
Principal Investigator: Ruth Perou, PhD Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP