School Readiness Program for Sickle Cell Disease
Recruiting in Palo Alto (17 mi)
Overseen byANDREW Heitzer, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: St. Jude Children's Research Hospital
No Placebo Group
Trial Summary
What is the purpose of this trial?The study participant is being asked to take part in this clinical trial, a type of research study, because the participant is a young child with sickle cell disease or the caregiver of a child with sickle cell disease. This study is being done to test a school readiness program for children with sickle cell disease (ages 3.5-6,5 years old).
Primary Objective
Assess feasibility and acceptability of an adapted school readiness intervention among preschool children (ages 3.5-6.5) diagnosed with sickle cell disease.
Secondary Objectives
Objective 1:
Measure preliminary efficacy of the adapted school readiness intervention compared to routine care among preschool children ages (3.5-6.5) diagnosed with sickle cell disease.
Objective 2:
Examine implementation factors (i.e., barriers and facilitators) during post-intervention.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that School Readiness Program for Sickle Cell Disease is an effective treatment?
The available research shows that children with sickle cell disease (SCD) often face challenges with school readiness and executive function skills, such as working memory. A study found that children with SCD performed worse than healthy peers in these areas, highlighting the need for interventions like the School Readiness Program. Another study compared routine services with a school intervention program for children with sickle cell anemia, suggesting that targeted school interventions could be beneficial. While the specific effectiveness of the School Readiness Program isn't detailed, the need for such interventions is supported by the challenges faced by children with SCD in school readiness and cognitive skills.
12345What safety data exists for the School Readiness Program for Sickle Cell Disease?
The provided research does not directly address safety data for the School Readiness Program for Sickle Cell Disease or its related interventions (The adapted Kids in Transition to School Intervention, Kids in Transition to School Intervention, KITS Intervention). The studies focus on feasibility, efficacy, and transition readiness for sickle cell disease interventions, but do not specifically mention safety data for the school readiness program.
13678Is the Kids in Transition to School Intervention a promising treatment for children with sickle cell disease?
Yes, the Kids in Transition to School Intervention is a promising treatment for children with sickle cell disease. It focuses on improving school readiness by enhancing executive function skills like working memory, which are crucial for early academic success. This intervention can help children with sickle cell disease better prepare for school, potentially leading to improved educational outcomes.
12359Eligibility Criteria
This trial is for preschool children aged 4-6 with sickle cell disease, or their caregivers. It aims to test a school readiness program specifically adapted for these children. Participants should be ready to engage in the study's activities and assessments.Inclusion Criteria
Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)
I am between 4 and 6 years old.
English as the primary language
+4 more
Exclusion Criteria
Non-English speakers
Do not have a child diagnosed with SCD of any genotype between the ages of 4.0-6.0 years and enrolled in SCCRIP
Participant Groups
The trial is testing an adapted Kids in Transition to School Intervention against standard school resources provided to young children with sickle cell disease. The goal is to assess how feasible and acceptable this tailored intervention is.
2Treatment groups
Experimental Treatment
Group I: Readiness InterventionExperimental Treatment1 Intervention
* Attend virtual classroom program sessions- If participants are in the school readiness group, the caregiver, will attend about 8 weeks of sessions virtually with a teacher or social worker and a caregiver of a child with sickle cell, for a total of 8 sessions. The sessions will be during the summer and done in a group. Each session will last about 1 ½ hours and will be video recorded. \> •Complete a caregiver interview-If participants are in the school readiness group, a member of the study team will interview you after the virtual classroom sessions are over. The interview will take about 15-20 minutes and will be audio recorded. Participants will be asked for suggestions and how satisfied you were with the program.
* Complete assessments - Caregiver and participant will complete a set of assessments that evaluate school readiness skills (e.g., early math and reading), child behaviors, and parent-child relationships before and after the intervention.
Group II: Control: Standard school resourcesExperimental Treatment1 Intervention
Parents will be provided with information about preschool programs available in the community and age appropriate books for their children
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St. Jude Children's Research HospitalMemphis, TN
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Who Is Running the Clinical Trial?
St. Jude Children's Research HospitalLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
A randomized, controlled pilot trial of a school intervention for children with sickle cell anemia. [2019]To investigate the feasibility and efficacy of a randomized clinical pilot trial comparing routine services (RS) with a school intervention program (SIP) for children with sickle cell anemia (SCA).
Working memory and school readiness in preschool children with sickle cell disease compared to demographically matched controls. [2023]Children diagnosed with sickle cell disease (SCD) are at risk of the development of neurobehavioural problems early in life. Specific impairments in executive function skills, including working memory, have been documented in school-aged children with SCD. These executive skills are known to strongly contribute to early academic skills and preparedness for entering kindergarten. This study examined working memory and school readiness in preschool children with SCD compared to a healthy control group matched for race, sex and parent education. A total of 84 patients diagnosed with SCD (61.9% haemoglobin [Hb]SS/HbSβ0 -thalassaemia) and 168 controls completed testing. The mean (SD) ages of patients and controls at testing were 4.53 (0.38) and 4.44 (0.65) years respectively. The SCD group performed worse than controls on measures of executive function, working memory and school readiness (p < 0.01; Cohen's D range: 0.32-0.39). Measures of working memory were associated with school readiness after accounting for early adaptive development. Multiple linear regression models among patients diagnosed with SCD revealed that college education of the primary caregiver was positively associated with school readiness (p < 0.001) after controlling for sex, genotype, age and early adaptive development. These results highlight the need to implement school readiness interventions in young children diagnosed with SCD emphasising executive function skills.
Web-Based Technology to Improve Disease Knowledge Among Adolescents With Sickle Cell Disease: Pilot Study. [2020]Advancements in treatment have contributed to increased survivorship among children with sickle cell disease (SCD). Increased transition readiness, encompassing disease knowledge and self-management skills before transfer to adult care, is necessary to ensure optimal health outcomes. The Sickle Cell Transition E-Learning Program (STEP) is a public, Web-based, 6-module tool designed to increase transition readiness for youth with SCD.
Lessons Learned From a Randomized Controlled Trial of a Family-Based Intervention to Promote School Functioning for School-Age Children With Sickle Cell Disease. [2022]Tested a family-based group problem-solving intervention, "Families Taking Control," (FTC) to improve school functioning and health-related quality of life (HRQL) for children with sickle cell disease.
Individual-level behavioral interventions to support optimal development of children with sickle cell disease: A systematic review. [2023]This review aimed to identify and describe individual-level behavioral interventions for children 0-18 years of age with sickle cell disease (SCD). PRISMA guidelines were followed at each stage of this review. Twenty-seven studies were included, representing six intervention types: disease knowledge (n = 7), self-management (n = 7), pain management (n = 4), school functioning (n = 4), cognitive health (n = 4), and mental health (n = 2). Most interventions targeted older children (5+ years), while only two examined interventions for children 0-3 years. This review suggests that offering education about disease knowledge, self-management, and pain management interventions can be beneficial for this population. Future research is needed to understand interventions to support young children and the impact of SCD on development.
A scoping review of transition interventions for young adults with sickle cell disease. [2023]Standardized programming for individuals with sickle cell disease (SCD) transitioning from pediatric to adult-centered care does not currently exist, resulting in high rates of mortality and morbidity. This scoping review examines and evaluates the current literature on SCD transition programs and interventions. Eligible studies described an existing program for individuals with SCD aged 12-29 years preparing to transition. The Evidence Project risk-of-bias tool was used to assess article quality. We identified 30 eligible articles, of which, only two were randomized controlled trials. Many studies have incomplete reports of feasibility information, such as completion rates, patient characteristics, and attrition; all studies were limited to a single institution; and most studies were rated high for risk of bias. Progress has been made in designing and gathering initial evaluation data for SCD transition programs; however, there is a need for higher quality studies, consistent assessment, and better dissemination of programs.
Implementation of an educational intervention to optimize self-management and transition readiness in young adults with sickle cell disease. [2023]The transition from the pediatric setting to adult care is a well-described period of morbidity and mortality for persons with sickle cell disease (SCD). We sought to measure the feasibility and effectiveness of providing skill-based educational handouts on improving self-management and transition readiness in adolescents with SCD.
Education Liaison improves implementation of school accommodations for students with sickle cell disease. [2023]Children with sickle cell disease (SCD) have lower academic attainment than healthy peers. Many benefit from neuropsychological testing (NPT) and educational accommodations, including Individualized Education Programs (IEPs) and Section 504 plans (504s). Despite medical barriers to academic attainment, many children with SCD do not receive indicated NPT or accommodations.
From cradle to commencement: transitioning pediatric sickle cell disease patients to adult providers. [2010]Children with sickle cell disease (SCD) are surviving past childhood and well into adulthood. Concerns are raised as to who is going to care for these children as they reach adulthood. We have developed a 2-part transition program. We have transitioned 20 of our 18- to 27-year-old patients to adult providers recognizing that early preparation is essential. At the newborn's initial visit or transfer from another clinic the transition program is explained to the family. At age 13 years, all our patients are given a "Preparation for Transition" binder. This binder is reviewed in detail with the patient and parent on a regular basis. At 18 years of age, coordinating with the milestone of graduating from high school and depending on developmental age, the transition is completed. The goal is a continuum of care in the transition process.