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

This study is ongoing, but not recruiting participants.
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: September 24, 2012
Last verified: September 2012

September 13, 2005
September 24, 2012
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 ] [ Designated as safety issue: No ]
  • child social skills [ Time Frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr ] [ Designated as safety issue: No ]
  • child cognition [ Time Frame: 1 yr, 3 yr, 5 yr ] [ Designated as safety issue: No ]
  • child language/communication [ Time Frame: 2 yr, 4 yr, 5 yr ] [ Designated as safety issue: No ]
  • child attachment [ Time Frame: 2 yr ] [ Designated as safety issue: No ]
  • child peer relationships [ Time Frame: 5 yr ] [ Designated as safety issue: No ]
  • child academics [ Time Frame: 4 yr, 5 yr ] [ Designated as safety issue: No ]
  • parent-child interaction [ Time Frame: 6 months, 5 yr ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • child violence exposure [ Time Frame: 2 yr, 4 yr, 5 yr ] [ Designated as safety issue: No ]
  • parenting [ Time Frame: baseline, 6 mos, 2 yr, 3 yr 5 yr ] [ Designated as safety issue: No ]
  • maternal health [ Time Frame: baseline, 1 yr 3 yr, 5 yr ] [ Designated as safety issue: No ]
  • maternal mental health [ Time Frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr ] [ Designated as safety issue: No ]
  • sense of community [ Time Frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr ] [ Designated as safety issue: No ]
  • community involvement [ Time Frame: baseline, 6 mos, 2yr, 3yr, 5 yr ] [ Designated as safety issue: No ]
  • coping [ Time Frame: 6mos, 2yr, 3 yr, 5 yr ] [ Designated as safety issue: No ]
  • HOME environment [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Efficacy Study
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
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.
 
Active, not recruiting
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
Both
18 Years and older
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
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