Developmental Disabilities Clinical Trial
Official title:
An RCT of a Low-Intensity Intervention to Reduce Delay
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention
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