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


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Child Behavior Disorders

Bullying


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

This study is no longer recruiting patients.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

Purpose

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.

Condition Treatment or Intervention Phase
Developmental Disabilities
Language Development Disorders
 Behavior: Age-specific parenting newsletters and developmental toys
 Behavior: Parent-completed Ages & Stages Questionnaires
 Behavior: Clinic-based distribution of children's books
Phase I

MedlinePlus related topics:  Developmental Disabilities;   Speech and Communication Disorders

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study

Official Title: An RCT of a Low-intensity Intervention to Reduce Delay

Further Study Details: 

Expected Total Enrollment:  600

Study start: March 2002;  Study completion: February 2006

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

Ages Eligible for Study:  4 Months   -   7 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Location Information


New York
      Montefiore Comprehensive Health Care Center, Bronx,  New York,  10451,  United States

      North Central Bronx Hospital Pediatric Clinic, Bronx,  New York,  10467,  United States

Study chairs or principal investigators

Harris S. Huberman, MD,  Principal Investigator,  Medical & Health Research Association of NYC, Inc.   

More Information

Study ID Numbers:  R01HD40388
Record last reviewed:  May 2005
Last Updated:  May 6, 2005
Record first received:  May 5, 2005
ClinicalTrials.gov Identifier:  NCT00110292
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-17


Source: ClinicalTrials.gov
Cache Date: May 18, 2005


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Page Updated: September 6, 2005
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