Legacy for Children, an Early Intervention Study to Promote Optimal Child Development in Low-income Families
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Legacy for Children, The CDC Parenting Research Projects |
- 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 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: | 547 |
| Study Start Date: | October 1999 |
| Estimated Study Completion Date: | February 2013 |
| Estimated 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
|
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 |
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| 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 | |
| Principal Investigator: | Ruth Perou, PhD | Centers for Disease Control and Prevention |
More Information
Additional Information:
No publications provided by Centers for Disease Control and Prevention
Additional 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 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 24, 2012 |
| 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 19, 2013