Clinical trial NCT00110292: Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
Official title: An RCT of a Low-Intensity Intervention to Reduce Delay
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Developmental Disabilities
Language Development Disorders
Keywords: Public health
Primary care
Parenting education
Child rearing
Parenting newsletters
Child development
Language delay
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2005-05-06
Enrollment: 600
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study will evaluate a program to prevent learning problems in children. The program is an inexpensive public health outreach program designed for families living in poverty and is administered through pediatricians' offices and clinics.

Detailed description: This study will assess the effectiveness of a low-intensity, low-cost, preventive intervention to reduce developmental delay and learning problems in young children. The goal is to improve home caregiving environment factors that are often suboptimal in families living in poverty; these families are often subject to social, economic, and medical risk factors. The intervention is based on a public health/primary care partnership and combines mailed parent-completed Ages \& Stages Questionnaires (ASQ), a monthly mailed age-paced parenting newsletter (Building Blocks) and corresponding developmental toys (BB), and a Reach Out and Read (ROR) physician-based distribution of children's books.

Families of 4- to 7-month-old children attending a participating pediatric clinic will be randomized to either an ASQ/BB+ROR group, an ROR-only group, or a no intervention control group. Outcomes measures will be obtained at 15, 24, 36, and 48 months of age and include measures of the home environment, parenting and parent-child interaction, child language and mental development measures, and rates of referral to Early Intervention programs. Baseline and ongoing demographic information and psychosocial and biological risk factors will also be gathered to see how they relate to child and family outcomes and to determine whether certain subgroups of families are more likely to benefit from the intervention than others.

Eligibility criteria: Inclusion Criteria

* Attend participating pediatric clinic (serving poor, largely black, and Hispanic communities)
* Family with child 4 to 7 months of age at enrollment
* English- or Spanish-speaking

Exclusion Criteria

* Developmental delay
* Eligible for Early Intervention program

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Comprehensive Health Care Center
state: New York
city: Bronx
country: United States
facility: North Central Bronx Hospital Pediatric Clinic
state: New York
Study officials:
affiliation: Medical & Health Research Association of NYC, Inc.
name: Harris S. Huberman, MD
role: PRINCIPAL_INVESTIGATOR
References: