Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00110292
Study type Interventional
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact
Status Active, not recruiting
Phase Phase 1
Start date March 2002
Completion date February 2006

See also
  Status Clinical Trial Phase
Completed NCT01274065 - Developing an Interdisciplinary Pharmacogenomic Treatment Approach to Reduce Medication Burden and Improve Outcomes Phase 4
Completed NCT01204151 - Teaching Math Skills to Individuals With Fragile X Syndrome N/A
Not yet recruiting NCT00531648 - Relationships Between Toddlers With Feeding Disorder and SPD and Their Parents N/A
Completed NCT00106652 - Childhood Autism Risks From Genetics and the Environment (The CHARGE Study) N/A
Not yet recruiting NCT06458959 - Exploratory Trial of a Pediatric Web-Based Care Planning Guide N/A
Completed NCT02714868 - Evaluation of Project TEAM (Teens Making Environmental and Activity Modifications) N/A
Completed NCT02090946 - The Experiences of Parents Learning Physiotherapy Techniques for Their Child N/A
Completed NCT01469117 - Feeding Trial in Pediatric Patients N/A
Enrolling by invitation NCT02745990 - Recombinant Human Erythropoietin Improve Neurodevelopmental Outcomes in Extremely Preterm Infants N/A
Completed NCT00465361 - Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit N/A
Completed NCT03447119 - Living Well With a Disability Curriculum Adaptation Evaluation Plan N/A
Completed NCT02561754 - Weight Management for Adolescents With IDD N/A
Completed NCT00723151 - Effects of Intensity of Early Communication Intervention Phase 2
Completed NCT02912065 - Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay N/A
Completed NCT02057809 - "Family-centered" Pediatric Rehabilitation Services in Children With Developmental Disabilities
Recruiting NCT02686931 - The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case N/A
Completed NCT02329509 - Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients N/A
Completed NCT00161135 - Magnetic Resonance Imaging in Children and Adolescents With Autism and Multiple Complex Developmental Disorders N/A
Recruiting NCT02082535 - S100B as a Marker of Brain Injury of Preterm Infants N/A
Completed NCT01882153 - Evaluating Parent Delivered Interventions for Children With Autism N/A