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

United States Department of Health and Human Services (HHS) logo

United States Department of Health and Human Services (HHS)

Status and phase

Unknown
Phase 1

Conditions

Developmental Disabilities
Language Development Disorders

Treatments

Behavioral: Clinic-based distribution of children's books
Behavioral: Age-specific parenting newsletters and developmental toys
Behavioral: Parent-completed Ages & Stages Questionnaires

Study type

Interventional

Funder types

NIH

Identifiers

NCT00110292
R01HD040388

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

4 to 7 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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