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

Sponsors and Collaborators:	Centers for Disease Control and Prevention RTI International University of California, Los Angeles University of Miami
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00164697

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

MedlinePlus related topics: Parenting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Legacy for Children, The CDC Parenting Research Projects

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 ] [ 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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	720
Study Start Date:	October 1999
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Arms

Assigned Interventions

1: Experimental

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Click here for information about this study: Legacy for Children This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	CDC ( Ruth Perou, Child Development Studies Team Leader )
Study ID Numbers:	CDC-NCBDDD-2524, 200-94-0828, 200-98-0110, 200-98-0111
Study First Received:	September 13, 2005
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00164697 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:

Child Development
Parenting
Child Rearing
Parent-Child Relations

ClinicalTrials.gov processed this record on May 06, 2009