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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An RCT of a Low-Intensity Intervention to Reduce Delay

Conditions
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Developmental Disabilities, Language Development Disorders

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 7 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Public health, Primary care, Parenting education, Child rearing, Parenting newsletters, Child development, Language delay