Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
An RCT of a Low-Intensity Intervention to Reduce Delay
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
This PHASE1 trial investigates Developmental Disabilities and Language Development Disorders and is currently ongoing. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) leads this study, which shows 7 recorded versions since 2002 — indicating limited longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.
Study Description(click to expand)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...
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.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Unknown PHASE1
-
Sep 2025 — Present [monthly]
Unknown PHASE1
-
Sep 2024 — Sep 2025 [monthly]
Unknown PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE1
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status PHASE1
▶ Show 2 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Unknown Status PHASE1
-
Jan 2017 — Jun 2018 [monthly]
Unknown Status PHASE1
First recorded
Mar 2002
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
For direct contact, visit the study record on ClinicalTrials.gov .