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

An RCT of a Low-Intensity Intervention to Reduce Delay

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00110292
Enrollment
600
Registered
2005-05-06
Start date
2002-03-31
Completion date
2006-02-28
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Disabilities, Language Development Disorders

Keywords

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

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.

Interventions

BEHAVIORALAge-specific parenting newsletters and developmental toys
BEHAVIORALParent-completed Ages & Stages Questionnaires
BEHAVIORALClinic-based distribution of children's books

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
4 Months to 7 Months
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026