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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Tracking Information
First Submitted Date  ICMJE May 5, 2005
First Posted Date  ICMJE May 6, 2005
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE March 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Condition  ICMJE
  • Developmental Disabilities
  • Language Development Disorders
Intervention  ICMJE
  • Behavioral: Age-specific parenting newsletters and developmental toys
  • Behavioral: Parent-completed Ages & Stages Questionnaires
  • Behavioral: Clinic-based distribution of children's books
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
600
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Months to 7 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00110292
Other Study ID Numbers  ICMJE R01HD040388( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harris S. Huberman, MD Medical & Health Research Association of NYC, Inc.
PRS Account Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP