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Completed

NCT Number: NCT00164697

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Department of Pediatrics, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parenting group

Behavioral

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

Primary outcomes

  1. child behavior

    Time frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr

  2. child social skills

    Time frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr

  3. child cognition

    Time frame: 1 yr, 3 yr, 5 yr

  4. child language/communication

    Time frame: 2 yr, 4 yr, 5 yr

  5. child attachment

    Time frame: 2 yr

  6. child peer relationships

    Time frame: 5 yr

  7. child academics

    Time frame: 4 yr, 5 yr

  8. parent-child interaction

    Time frame: 6 months, 5 yr

Secondary outcomes

  1. child physical growth

    Time frame: baseline, 6 month, 1 yr, 2 yr

  2. child violence exposure

    Time frame: 2 yr, 4 yr, 5 yr

  3. parenting

    Time frame: baseline, 6 mos, 2 yr, 3 yr 5 yr

  4. maternal health

    Time frame: baseline, 1 yr 3 yr, 5 yr

  5. maternal mental health

    Time frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr

  6. sense of community

    Time frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr

  7. community involvement

    Time frame: baseline, 6 mos, 2yr, 3yr, 5 yr

  8. coping

    Time frame: 6mos, 2yr, 3 yr, 5 yr

  9. HOME environment

    Time frame: 1 yr

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • RTI International
  • University of California, Los Angeles
  • University of Miami

Registry information

Official study title

Legacy for Children, The CDC Parenting Research Projects

Acronym: Legacy

Important dates

Study start
1999
Primary completion
2013
Study completion
2013
First posted
Sep 14, 2005
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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