Faith-Based and Community Initiatives |
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Clinical Trial: Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
This study is no longer recruiting patients.
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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
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
Harris S. Huberman, MD, Principal Investigator, Medical & Health Research Association of NYC, Inc.
More Information
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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