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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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)

Investigators

Principal Investigator:	Harris S. Huberman, MD	Medical & Health Research Association of NYC, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00110292 History of Changes
Other Study ID Numbers:	R01HD040388 ( U.S. NIH Grant/Contract )
First Posted:	May 6, 2005
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:

Developmental Disabilities; Language Development Disorders; Neurodevelopmental Disorders; Mental Disorders; Language Disorders	Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms