Testing the Sickle Cell Caregiver Collaboration for Child Development (SCCCD) Intervention

Early Identification and Intervention Of Developmental Delay Among Infants And Toddlers With Sickle Cell Disease Using the Sickle Cell Caregiver Collaboration for Child Development (SCCCD) Intervention

Sickle cell disease affects 100,000 people and 2,000 newborns each year; 50% of these children have a developmental deficit (>2 SD) before the age of 3. Early identification of developmental deficit supports timely intervention, but children with sickle cell disease are grossly underdiagnosed and undertreated. The goal of the proposed study is to determine the incidence and severity of developmental deficit at 9, 18 and 30 months of age among children with sickle cell disease and test a 12-month, home-based caregiver intervention with this disproportionately affected population.

This trial will be conducted in two phases. In Aim 1, the investigators are evaluating the developmental progress of children with and without sickle cell disease (SCD) at 9, 18, and 30 months. The investigators aim to recruit a total of 100 children and their caregivers (SCD = 50, Comparison = 50). Each child/caregiver dyad will be asked to complete 3 evaluation visits where the child's developmental progress will be evaluated and the caregiver will complete surveys related to their child's development, participation, and the caregiver's mental health.

In Aim 2, children with sickle cell disease will be randomized to receive developmental evaluations at 9, 18, and 30 months alone or a 12-month home-based intervention + developmental evaluations. The intervention is called the Sickle Cell Collaboration for Child Development (SCCCD) uses the widely used Parents as Teachers curriculum and is supplemented with specific support for the caregivers related to the child's sickle cell diagnosis. This pilot randomized controlled trial design is designed to (1) examine the potential effects of SCCCD on child development and caregiver well-being compared to the group with no intervention and (2) optimize trial procedures to enhance acceptability and scalability in preparation for a full-scale trial. Data will be collected to explore determinants (facilitators and barriers) affecting participation and outcomes. The investigators will recruit 50 children with sickle cell disease to this aim, with the goal to have 25 children randomized to intervention. Randomization will be completed using a random computer generator that can balance groups based on key factors like age, sex, and area deprivation index (index approximating income and community resources).

Participants randomized to SCCCD (n=25) will be invited to participate in 12 home-based intervention session over the course of 1 year (1 visit monthly) with a trained parent educator. They will complete the visit according to the Parents as Teachers curriculum and will provide additional discussion focused on sickle cell disease and strategies to promote child development. If caregivers are uncomfortable with home-visits, families will have the option to complete intervention visits in our on-site clinic space or in a preferred community location (e.g., public library, child care setting, place of worship). Participants in the developmental evaluation group will complete study visits as described in Aim 1.

The primary outcomes are child development and caregiver acceptability of developmental screening and intervention. The investigators will use implementation strategies guided by our earlier work to optimize the program's feasibility which will be measured by tracking participation and retention rates in each phase of this study. Acceptability will be assessed through interviews and surveys.

Inclusion Criteria:

• All sickle cell disease genotypes will be included. Children will be eligible to participate until they reach 31 months of age (1 month over target evaluation).

Exclusion Criteria:

• Children will be excluded if the child has fragile health, a diagnosis associated with developmental deficit (not sickle cell disease), or the family is not English language proficient -because of limitations in alternative language assessment and intervention delivery.