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

Child Development Clinical Trial

— Legacy  

Official title:

Legacy for Children, The CDC Parenting Research Projects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164697
• Other study ID #: CDC-NCBDDD-2524
• Secondary ID: 200-94-0828200-9
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: February 2, 2016
• Start date: October 1999
• Est. completion date: February 2013

Study information

• Verified date: September 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Development

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Department of Pediatrics	Los Angeles	California
United States	University of Miami School of Medicine	MIami	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	RTI International, University of California, Los Angeles, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	child behavior		1yr, 2 yr, 3 yr, 4 yr, 5 yr	No
Primary	child social skills		1yr, 2 yr, 3 yr, 4 yr, 5 yr	No
Primary	child cognition		1 yr, 3 yr, 5 yr	No
Primary	child language/communication		2 yr, 4 yr, 5 yr	No
Primary	child attachment		2 yr	No
Primary	child peer relationships		5 yr	No
Primary	child academics		4 yr, 5 yr	No
Primary	parent-child interaction		6 months, 5 yr	No
Secondary	child physical growth		baseline, 6 month, 1 yr, 2 yr	No
Secondary	child violence exposure		2 yr, 4 yr, 5 yr	No
Secondary	parenting		baseline, 6 mos, 2 yr, 3 yr 5 yr	No
Secondary	maternal health		baseline, 1 yr 3 yr, 5 yr	No
Secondary	maternal mental health		baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr	No
Secondary	sense of community		baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr	No
Secondary	community involvement		baseline, 6 mos, 2yr, 3yr, 5 yr	No
Secondary	coping		6mos, 2yr, 3 yr, 5 yr	No
Secondary	HOME environment		1 yr	No

External Links

•   Click here for information about this study: Legacy for Children