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

Tracking Information

First Received Date ^ICMJE

May 5, 2005

Last Updated Date

June 23, 2005

Start Date ^ICMJE

March 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00110292 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An RCT of a Low-Intensity Intervention to Reduce Delay

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Developmental Disabilities
Language Development Disorders

Intervention ^ICMJE

Behavioral: Age-specific parenting newsletters and developmental toys
Behavioral: Parent-completed Ages & Stages Questionnaires
Behavioral: Clinic-based distribution of children's books

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

600

Completion Date

February 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

4 Months to 7 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00110292

Responsible Party

Study ID Numbers ^ICMJE

R01HD40388

Study Sponsor ^ICMJE

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Harris S. Huberman, MD

Medical & Health Research Association of NYC, Inc.

Information Provided By

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Verification Date

May 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP