Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
Primary Purpose
Developmental Disabilities, Language Development Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Age-specific parenting newsletters and developmental toys
Parent-completed Ages & Stages Questionnaires
Clinic-based distribution of children's books
Sponsored by
About this trial
This is an interventional prevention trial for Developmental Disabilities focused on measuring Public health, Primary care, Parenting education, Child rearing, Parenting newsletters, Child development, Language delay
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
Sites / Locations
- Montefiore Comprehensive Health Care Center
- North Central Bronx Hospital Pediatric Clinic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00110292
First Posted
May 5, 2005
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00110292
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Disabilities, Language Development Disorders
Keywords
Public health, Primary care, Parenting education, Child rearing, Parenting newsletters, Child development, Language delay
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Age-specific parenting newsletters and developmental toys
Intervention Type
Behavioral
Intervention Name(s)
Parent-completed Ages & Stages Questionnaires
Intervention Type
Behavioral
Intervention Name(s)
Clinic-based distribution of children's books
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harris S. Huberman, MD
Organizational Affiliation
Medical & Health Research Association of NYC, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Comprehensive Health Care Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
North Central Bronx Hospital Pediatric Clinic
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
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Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
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