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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00164697
First Posted: September 14, 2005
Last Update Posted: February 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
RTI International
University of California, Los Angeles
University of Miami
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
  Purpose
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.

Condition Intervention
Child Development Behavioral: Parenting group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Legacy for Children, The CDC Parenting Research Projects

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 547
Study Start Date: October 1999
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Parenting group
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
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164697


Locations
United States, California
UCLA Department of Pediatrics
Los Angeles, California, United States, 90095
United States, Florida
University of Miami School of Medicine
MIami, Florida, United States, 33101
Sponsors and Collaborators
Centers for Disease Control and Prevention
RTI International
University of California, Los Angeles
University of Miami
Investigators
Principal Investigator: Ruth Perou, PhD Centers for Disease Control and Prevention
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00164697     History of Changes
Other Study ID Numbers: CDC-NCBDDD-2524
200-94-0828
200-98-0110
200-98-0111
First Submitted: September 13, 2005
First Posted: September 14, 2005
Last Update Posted: February 3, 2016
Last Verified: September 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centers for Disease Control and Prevention:
Child Development
Parenting
Child Rearing
Parent-Child Relations