NCT00110292

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2005

First QC Date

May 5, 2005

Last Update Submit

June 23, 2005

Conditions

Developmental DisabilitiesLanguage Development Disorders

Keywords

Public healthPrimary careParenting educationChild rearingParenting newslettersChild developmentLanguage delay

Interventions

Age-specific parenting newsletters and developmental toysBEHAVIORAL
Parent-completed Ages & Stages QuestionnairesBEHAVIORAL
Clinic-based distribution of children's booksBEHAVIORAL

Eligibility Criteria

Age4 Months - 7 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Developmental delay
  • Eligible for Early Intervention program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montefiore Comprehensive Health Care Center

The Bronx, New York, 10451, United States

Location

North Central Bronx Hospital Pediatric Clinic

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Developmental DisabilitiesLanguage Development Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Harris S. Huberman, MD

    Medical & Health Research Association of NYC, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 5, 2005

First Posted

May 6, 2005

Study Start

March 1, 2002

Study Completion

February 1, 2006

Last Updated

June 24, 2005

Record last verified: 2005-05

Locations

US(2)