This trial is active, not recruiting.

Conditions developmental disabilities, language development disorders
Treatments age-specific parenting newsletters and developmental toys, parent-completed ages & stages questionnaires, clinic-based distribution of children's books
Phase phase 1
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date March 2002
End date February 2006
Trial size 600 participants
Trial identifier NCT00110292, R01HD40388


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind
Primary purpose prevention

Eligibility Criteria

Male or female participants from 4 months up to 7 months old.

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

Additional Information

Official title An RCT of a Low-Intensity Intervention to Reduce Delay
Principal investigator Harris S. Huberman, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).