Peer-reviewed article
Early Developmental Screening and a Home-Based Caregiver Intervention for Infants and Toddlers With Sickle Cell Disease: Protocol for a Prospective Mixed Methods Study.
Hoyt CR, Moore HG, Housten AJ, Baumann AA, King AA ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study examines developmental delays in infants and toddlers with sickle cell disease in the United States, who are disproportionately Black or African American. Researchers will screen children with sickle cell disease at 9, 18, and 30 months to determine how common developmental delays are compared to typically developing peers. They are testing a 12-month home-based intervention combining occupational therapy, parent education, and disease-specific training delivered through monthly home visits. The study will also explore what helps or hinders families from participating in the intervention to prepare for larger-scale implementation.
Key points
- More than 50% of children with sickle cell disease showed developmental delays before age 3 in earlier work, but none had been diagnosed or referred for services
- Children whose caregivers participated in a home-based caregiver education program demonstrated improved scores on standardized developmental measures in pilot work
- The intervention combines occupational therapy, the Parents as Teachers curriculum, and sickle cell disease-specific caregiver education delivered over 12 monthly home visits
- Bayley Scales of Infant Development, Fourth Edition will be used to assess development at 9, 18, and 30 months compared to demographically matched controls
- As of May 2026, 50 participants have enrolled in the comparison phase (26 with sickle cell disease, 24 typically developing controls) and 5 dyads have begun the intervention phase
Limitations
This is a protocol paper describing a study still in progress (expected completion 2028), so no results are yet available. The document does not provide information about potential harms, cost-effectiveness, or long-term outcomes beyond the study period.
Abstract
Background Sickle cell disease (SCD) is the most common monogenic disorder in humans and occurs predominantly among individuals who identify as Black or African American in the United States. In earlier work, we found that developmental delays were present in more than 50% of children with SCD before the age of 3 years, yet none had been diagnosed or referred to intervention services. Children whose caregivers participated in a home-based caregiver education program demonstrated improved scores on standardized developmental measures. When developmental delays go unidentified, children miss a critical opportunity for intervention during a period of rapid neurological change. Yet few, if any, studies have described the incidence and severity of developmental delays among children with SCD compared to controls. Objective The purpose of this study is to determine the incidence and severity of developmental delays in children with SCD under 3 years of age (aim 1), test a 12-month home-based Sickle Cell Collaboration for Child Development (SCCCD) intervention (aim 2), and conduct a mixed methods study to identify contextual determinants to prepare for future scaling of the SCCCD intervention across health care systems (aim 3). Methods Consistent with American Academy of Pediatrics guidelines, children with SCD will be evaluated at 9, 18, and 30 months using the Bayley Scales of Infant Development, Fourth Edition, to determine the incidence of developmental delay over the first 3 years of life compared to demographically matched peers (n=100, aim 1). The SCCCD intervention, adapted from a pilot study, combines skilled occupational therapy, the Parents as Teachers curriculum, and SCD-specific caregiver education, delivered over 12 monthly home visits (n=25, aim 2). Interviews with caregivers who participated in and those who declined the intervention will identify contextual determinants (ie, facilitators and barriers) to inform future testing and broader implementation of the SCCCD (aim 3). Results This project has been approved by the Institutional Review Board at Washington University School of Medicine (202104034 and 202407080). As of May 31, 2026, a total of 50 participants (26 children with SCD and 24 typically developing children for the comparison cohort) have participated for aim 1. Aim 2 recruitment began in July 2025, and 5 caregiver/child dyads have participated so far. The study is expected to be completed by 2028. Conclusions These findings will provide the first prospective characterization of developmental trajectories in children with SCD across the first 3 years of life and establish preliminary evidence for a disease-specific, home-based intervention to improve developmental outcomes in this underserved population. The results will directly inform a future randomized controlled trial of the SCCCD intervention.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Home-based Sickle Cell Collaboration for Child Development (SCCCD) intervention combining skilled occupational therapy, Parents as Teachers curriculum, and sickle cell disease-specific caregiver education delivered over 12 monthly home visits.
- Population
- Infants and toddlers with sickle cell disease under 3 years of age and their caregivers (target n=25 for intervention arm).
Key finding
Study is ongoing with results expected by 2028
CR et al. · Europe PMC · 14 Aug 2026