Testing the Sickle Cell Caregiver Collaboration for Child Development (SCCCD) Intervention
NCT Number: NCT06562439
Acronym: SCCCD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sickle Cell Disease
Interventions: BEHAVIORAL: Sickle Cell Collaboration for Child Development
Sponsor: Washington University School of Medicine
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2025-01-01
Completion Date: 2028-07-31
Locations: Washington University School of Medicine, Saint Louis, Missouri, 63108, United States

Summary:
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.

Primary Outcome Measures: Bayley Scales of Infant Toddler Development-IV, Child participants will complete up to 3 developmental evaluations with a trained evaluator using the Bayley Scales of Infant Toddler Development-IV. The Bayley assesses development in the domains of cognition, fine and gross motor, and expressive and receptive language. Caregiver questionnaires assess adaptive behavior and social emotional development. Scaled scores range from 1-19, where a score of 10 is average and a higher score indicates better outcome., Completed at 9, 18 and 30 months|Ages and Stages Questionnaire-3, Caregivers will complete the Ages and Stages Questionnaire-3, which assesses the caregivers perspective of how their child is meeting developmental milestones in the domains of communication, gross motor, fine motor, personal-social and problem solving. Scores range from 0-60, where a higher score indicates a better outcome., Completed at 9, 18 and 30 months|Infant Toddler Activity Card Sort, Caregivers will complete the Infant Toddler Activity Card Sort (ITACS) to determine activities and routines that are presenting performance or participation challenges for families in the context of their everyday lives., Completed at 9, 18 and 30 months|Behavior Rating Inventory of Executive Function-Preschool, The Behavior Rating Inventory of Executive Function-Preschool (BRIEF) evaluates executive functioning of toddlers \>2.5 years. Executive functioning is identified as a high risk domain for deficits among individuals with sickle cell disease. Raw scores are converted to t-scores (mean = 50, SD = 10) and scores above 65 are considered clinically significant., 30 months of age
Secondary Outcome Measures: PROMIS Depression (Caregiver), The Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression short form is a valid and reliable 8-item tool to screen for depression. Scores range from 8-40, with higher scores indicating more severe depression symptoms., Completed at child's 9, 18 and 30 month evaluation.|Acceptability, Study visit completion rates and notes from intervention visits will be reviewed. Interviews will be conducted with all participants in the SCCCD intervention, regardless of completion to determine components that contributed to participation or attrition., through study completion, an average of 1 year|Fidelity, The Comprehensive Intervention Fidelity Guide will be used to evaluate intervention design, training and delivery. This guide specifies the intervention model, the fidelity indices (e.g., participation and retention rates) and compare those to outcome measures., through study completion, an average of 1 year