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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.
Study NCT00110292.   Last updated on June 23, 2005.   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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Descriptive Information Fields
Brief Title  Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
Official Title  An RCT of a Low-Intensity Intervention to Reduce 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.

Study Phase Phase I
Study Type  Interventional
Study Design  Prevention, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Developmental Disabilities
Language Development Disorders
Intervention  Behavioral: Age-specific parenting newsletters and developmental toys
Behavioral: Parent-completed Ages & Stages Questionnaires
Behavioral: Clinic-based distribution of children's books
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  600
Start Date  March 2002
Completion Date February 2006
Eligibility 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
Gender Both
Ages 4 Months to 7 Months
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00110292
Organization ID R01HD40388
Secondary IDs ††
Study Sponsor  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators ††
Investigators 
Principal Investigator:     Harris S. Huberman, MD     Medical & Health Research Association of NYC, Inc.    
Information Provided By Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date May 2005
First Received Date  May 5, 2005
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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