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

February 2, 2016 updated by: Centers for Disease Control and Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

547

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90095
        • UCLA Department of Pediatrics
    • Florida
      • MIami, Florida, United States, 33101
        • University of Miami School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
child behavior
Time Frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr
1yr, 2 yr, 3 yr, 4 yr, 5 yr
child social skills
Time Frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr
1yr, 2 yr, 3 yr, 4 yr, 5 yr
child cognition
Time Frame: 1 yr, 3 yr, 5 yr
1 yr, 3 yr, 5 yr
child language/communication
Time Frame: 2 yr, 4 yr, 5 yr
2 yr, 4 yr, 5 yr
child attachment
Time Frame: 2 yr
2 yr
child peer relationships
Time Frame: 5 yr
5 yr
child academics
Time Frame: 4 yr, 5 yr
4 yr, 5 yr
parent-child interaction
Time Frame: 6 months, 5 yr
6 months, 5 yr

Secondary Outcome Measures

Outcome Measure
Time Frame
child physical growth
Time Frame: baseline, 6 month, 1 yr, 2 yr
baseline, 6 month, 1 yr, 2 yr
child violence exposure
Time Frame: 2 yr, 4 yr, 5 yr
2 yr, 4 yr, 5 yr
parenting
Time Frame: baseline, 6 mos, 2 yr, 3 yr 5 yr
baseline, 6 mos, 2 yr, 3 yr 5 yr
maternal health
Time Frame: baseline, 1 yr 3 yr, 5 yr
baseline, 1 yr 3 yr, 5 yr
maternal mental health
Time Frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
sense of community
Time Frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
community involvement
Time Frame: baseline, 6 mos, 2yr, 3yr, 5 yr
baseline, 6 mos, 2yr, 3yr, 5 yr
coping
Time Frame: 6mos, 2yr, 3 yr, 5 yr
6mos, 2yr, 3 yr, 5 yr
HOME environment
Time Frame: 1 yr
1 yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

September 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • CDC-NCBDDD-2524
  • 200-94-0828
  • 200-98-0110
  • 200-98-0111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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