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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110292
Recruitment Status : Unknown
Verified May 2005 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Active, not recruiting
First Posted : May 6, 2005
Last Update Posted : June 24, 2005
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Condition or disease Intervention/treatment 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 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: An RCT of a Low-Intensity Intervention to Reduce Delay
Study Start Date : March 2002
Study Completion Date : February 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110292

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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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Harris S. Huberman, MD Medical & Health Research Association of NYC, Inc.

Layout table for additonal information Identifier: NCT00110292     History of Changes
Other Study ID Numbers: R01HD040388 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2005    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2005
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Public health
Primary care
Parenting education
Child rearing
Parenting newsletters
Child development
Language delay
Additional relevant MeSH terms:
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Language Development Disorders
Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms