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

This study is ongoing, but not recruiting participants.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00110292
  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 Intervention Phase
Developmental Disabilities
Language Development Disorders
Behavioral: Age-specific parenting newsletters and developmental toys
Behavioral: Parent-completed Ages & Stages Questionnaires
Behavioral: Clinic-based distribution of children's books
Phase I

MedlinePlus related topics:   Developmental Disabilities    Parenting   

U.S. FDA Resources

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

Estimated Enrollment:   600
Study Start Date:   March 2002
Estimated Study Completion Date:   February 2006

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.

  Eligibility
Ages Eligible for Study:   4 Months to 7 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110292

Locations
United States, New York
Montefiore Comprehensive Health Care Center    
      Bronx, New York, United States, 10451
North Central Bronx Hospital Pediatric Clinic    
      Bronx, New York, United States, 10467

Sponsors and Collaborators

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


Study ID Numbers:   R01HD40388
First Received:   May 5, 2005
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00110292
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Child Health and Human Development (NICHD):
Public health  
Primary care  
Parenting education  
Child rearing  
Parenting newsletters
Child development
Language delay

Study placed in the following topic categories:
Developmental Disabilities
Signs and Symptoms
Mental Disorders
Mental Disorders Diagnosed in Childhood
Language Development Disorders
Neurologic Manifestations
Language Disorders
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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