Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach

NCT ID: NCT00110292

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2006-02-28

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.

Conditions

Developmental Disabilities; Language Development Disorders

Keywords

Public health; Primary care; Parenting education; Child rearing; Parenting newsletters; Child development; Language delay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Age-specific parenting newsletters and developmental toys

Intervention Type: BEHAVIORAL

Parent-completed Ages & Stages Questionnaires

Intervention Type: BEHAVIORAL

Clinic-based distribution of children's books

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 7 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Principal Investigators

Harris S. Huberman, MD

Role: PRINCIPAL_INVESTIGATOR

Medical & Health Research Association of NYC, Inc.

Locations

Montefiore Comprehensive Health Care Center

The Bronx, New York, United States

North Central Bronx Hospital Pediatric Clinic

The Bronx, New York, United States

Countries

United States

Other Identifiers

R01HD040388

Identifier Type: NIH

Identifier Source: org_study_id

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