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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00110292
Other study ID # R01HD040388
Secondary ID
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
Est. primary completion date
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


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, 

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