Legacy for Children, an Early Intervention Study to Promote Optimal Child Development in Low-income Families
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | September 24, 2012 | ||||
| Start Date ICMJE | October 1999 | ||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00164697 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Legacy for Children, an Early Intervention Study to Promote Optimal Child Development in Low-income Families | ||||
| Official Title ICMJE | Legacy for Children, The CDC Parenting Research Projects | ||||
| Brief Summary | 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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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Child Development | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: 1
Parenting group
Intervention: Behavioral: Parenting group |
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| Publications * | Perou R, Elliott MN, Visser SN, Claussen AH, Scott KG, Beckwith LH, Howard J, Katz LF, Smith DC. Legacy for ChildrenTM: a pair of randomized controlled trials of a public health model to improve developmental outcomes among children in poverty. BMC Public Health. 2012 Aug 23;12:691. doi: 10.1186/1471-2458-12-691. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 547 | ||||
| Estimated Completion Date | February 2013 | ||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00164697 | ||||
| Other Study ID Numbers ICMJE | CDC-NCBDDD-2524, 200-94-0828, 200-98-0110, 200-98-0111 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Centers for Disease Control and Prevention | ||||
| Study Sponsor ICMJE | Centers for Disease Control and Prevention | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Centers for Disease Control and Prevention | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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