Skip to main content
Clinical Trials/NCT00110292
NCT00110292
Unknown
Phase 1

An RCT of a Low-Intensity Intervention to Reduce Delay

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)2 sites in 1 country600 target enrollmentMarch 2002

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Developmental Disabilities
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Enrollment
600
Locations
2
Last Updated
20 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2002
End Date
February 2006
Last Updated
20 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (2)

Loading locations...

Similar Trials