Clinical trial NCT00164697: Legacy for Children, an Early Intervention Study to Promote Optimal Child Development in Low-income Families
Official title: Legacy for Children, The CDC Parenting Research Projects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Keywords: Child Development
Parenting
Child Rearing
Parent-Child Relations
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: RTI International
name: University of California, Los Angeles
name: University of Miami
First posted: 2005-09-14
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: child behavior
timeFrame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr
measure: child social skills
timeFrame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr
measure: child cognition
timeFrame: 1 yr, 3 yr, 5 yr
measure: child language/communication
timeFrame: 2 yr, 4 yr, 5 yr
measure: child attachment
timeFrame: 2 yr
measure: child peer relationships
timeFrame: 5 yr
measure: child academics
timeFrame: 4 yr, 5 yr
measure: parent-child interaction
timeFrame: 6 months, 5 yr
Secondary outcomes:
measure: child physical growth
timeFrame: baseline, 6 month, 1 yr, 2 yr
measure: child violence exposure
timeFrame: 2 yr, 4 yr, 5 yr
measure: parenting
timeFrame: baseline, 6 mos, 2 yr, 3 yr 5 yr
measure: maternal health
timeFrame: baseline, 1 yr 3 yr, 5 yr
measure: maternal mental health
timeFrame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
measure: sense of community
timeFrame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
measure: community involvement
timeFrame: baseline, 6 mos, 2yr, 3yr, 5 yr
measure: coping
timeFrame: 6mos, 2yr, 3 yr, 5 yr
measure: HOME environment
timeFrame: 1 yr
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Department of Pediatrics
state: California
city: MIami
country: United States
facility: University of Miami School of Medicine
state: Florida
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Ruth Perou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barry CM, Robinson LR, Kaminski JW, Danielson ML, Jones CL, Lang DL. Behavioral and Socioemotional Outcomes of the Legacy for Children Randomized Control Trial to Promote Healthy Development of Children Living in Poverty, 4 to 6 Years Postintervention. J Dev Behav Pediatr. 2022 Jan 1;43(1):e39-e47. doi: 10.1097/DBP.0000000000000962.
citation: 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.