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

Study Overview
=================
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.

Official Title
-----------------
Legacy for Children, The CDC Parenting Research Projects

Conditions
-----------------
Child Development

Intervention / Treatment
-----------------
* Behavioral: Parenting group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Parenting group | Behavioral: Parenting group<br>* 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.<br>* Other names: Behavioral;|
| No Intervention: 2<br>Families in this usual care comparison group were not prevented from utilizing any service that would otherwise be available to them, even if the service was similar to the services received in the intervention arm of the study. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| child behavior |  | 1yr, 2 yr, 3 yr, 4 yr, 5 yr | 
| child social skills |  | 1yr, 2 yr, 3 yr, 4 yr, 5 yr | 
| child cognition |  | 1 yr, 3 yr, 5 yr | 
| child language/communication |  | 2 yr, 4 yr, 5 yr | 
| child attachment |  | 2 yr | 
| child peer relationships |  | 5 yr | 
| child academics |  | 4 yr, 5 yr | 
| parent-child interaction |  | 6 months, 5 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| child physical growth |  | baseline, 6 month, 1 yr, 2 yr | 
| child violence exposure |  | 2 yr, 4 yr, 5 yr | 
| parenting |  | baseline, 6 mos, 2 yr, 3 yr 5 yr | 
| maternal health |  | baseline, 1 yr 3 yr, 5 yr | 
| maternal mental health |  | baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr | 
| sense of community |  | baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr | 
| community involvement |  | baseline, 6 mos, 2yr, 3yr, 5 yr | 
| coping |  | 6mos, 2yr, 3 yr, 5 yr | 
| HOME environment |  | 1 yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child Development, Parenting, Child Rearing, Parent-Child Relations