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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00110292 |
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 | Intervention | Phase |
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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 I |
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 |
Estimated Enrollment: | 600 |
Study Start Date: | March 2002 |
Estimated Study Completion Date: | 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.
Ages Eligible for Study: | 4 Months to 7 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
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 |
Principal Investigator: | Harris S. Huberman, MD | Medical & Health Research Association of NYC, Inc. |
Study ID Numbers: | R01HD40388 |
Study First Received: | May 5, 2005 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00110292 History of Changes |
Health Authority: | United States: Federal Government |
Public health Primary care Parenting education Child rearing |
Parenting newsletters Child development Language delay |
Developmental Disabilities Signs and Symptoms Mental Disorders Mental Disorders Diagnosed in Childhood Language Development Disorders |
Neurologic Manifestations Language Disorders Neurobehavioral Manifestations Communication Disorders |
Developmental Disabilities Signs and Symptoms Mental Disorders Nervous System Diseases Mental Disorders Diagnosed in Childhood |
Language Development Disorders Neurologic Manifestations Language Disorders Neurobehavioral Manifestations Communication Disorders |