Trial record 3 of 13 for:    "Language Development Disorders"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00110292
First received: May 5, 2005
Last updated: June 23, 2005
Last verified: May 2005
  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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: An RCT of a Low-Intensity Intervention to Reduce Delay

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 600
Study Start Date: March 2002
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   4 Months to 7 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110292

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

No publications provided

ClinicalTrials.gov Identifier: NCT00110292     History of Changes
Other Study ID Numbers: R01HD40388
Study First Received: May 5, 2005
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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
Mental Disorders Diagnosed in Childhood
Mental Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014