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

Developmental Disabilities Clinical Trial

Official title:

An RCT of a Low-Intensity Intervention to Reduce Delay

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00110292
• Other study ID #: R01HD040388
• Status: Active, not recruiting
• Phase: Phase 1
• First received: May 5, 2005
• Last updated: June 23, 2005
• Start date: March 2002
• Est. completion date: February 2006

Study information

• Verified date: May 2005
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Months to 7 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Developmental Disabilities
• Language Development Disorders

Intervention

Behavioral:
• Age-specific parenting newsletters and developmental toys

• Parent-completed Ages & Stages Questionnaires

• Clinic-based distribution of children's books

Locations

Country	Name	City	State
United States	Montefiore Comprehensive Health Care Center	Bronx	New York
United States	North Central Bronx Hospital Pediatric Clinic	Bronx	New York

Sponsors (1)

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

Country where clinical trial is conducted

United States,