School Readiness Program for Sickle Cell Disease

Overseen By ANDREW HEITZER, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to prepare young children with sickle cell disease for school. The main goal is to determine if the adapted Kids in Transition to School Intervention is practical and well-received by children aged 3.5 to 6.5 years with sickle cell disease. Researchers will also compare the program's effectiveness to regular school resources and identify any challenges in its implementation. Participants include English-speaking children with sickle cell disease enrolled in a specific research program, along with a willing caregiver. As an unphased trial, this study allows participants to contribute to innovative educational support strategies for young children with sickle cell disease.

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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a school readiness program, so it's unlikely that medication changes are required, but you should confirm with the trial coordinators.

What prior data suggests that this school readiness program is safe for children with sickle cell disease?

Research shows that the adapted Kids in Transition to School Intervention helps children with sickle cell disease prepare for school. An initial trial involved 24 children with sickle cell anemia in a similar school program. This program significantly improved their understanding of their condition without causing any negative effects.

While specific safety data for this exact program is unavailable, it focuses on educational support, suggesting it is likely safe. Similar educational programs have generally been safe, as they primarily involve learning activities and include caregivers. Any major safety issues would likely have been identified in earlier studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the School Readiness Program for Sickle Cell Disease because it offers a novel approach to supporting children with this condition as they prepare for school. Unlike standard resources that simply provide information and books, this program involves interactive virtual classroom sessions where caregivers and children engage with educators and social workers. This personalized and immersive method aims to enhance school readiness skills, such as early math and reading, while also strengthening parent-child relationships. By focusing on these developmental areas, the program hopes to give children with sickle cell disease a better start in their educational journey.

What evidence suggests that the adapted Kids in Transition to School Intervention is effective for school readiness in children with sickle cell disease?

Research has shown that the Kids in Transition to School (KITS) Program could benefit children with sickle cell disease. In this trial, participants in the school readiness group will receive the adapted KITS Intervention. Previous studies have found that similar school programs can greatly improve children's understanding of their condition. Another study on children with developmental and behavior issues found that KITS helped them prepare for school by boosting early math and reading skills. These findings suggest that using KITS for children with sickle cell disease might enhance their school readiness by focusing on key learning and development areas. This targeted support may help children manage both their school and health challenges more effectively. ^{1 2 3 6 7}

Who Is on the Research Team?

ANDREW Heitzer, PhD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend virtual classroom program sessions for school readiness, including caregiver interviews and assessments

8 weeks

8 virtual sessions

Follow-up

Participants are monitored for school readiness skills and caregiver satisfaction after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• The adapted Kids in Transition to School Intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: Readiness Intervention Experimental Treatment 1 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 resources Experimental Treatment 1 Intervention

Parents will be provided with information about preschool programs available in the community and age appropriate books for their children

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The review analyzed 27 studies on behavioral interventions for children with sickle cell disease, highlighting the effectiveness of education on disease knowledge, self-management, and pain management, particularly for older children (5+ years).

There is a significant gap in research for interventions aimed at younger children (0-3 years), indicating a need for future studies to explore how to support this age group and understand the developmental impacts of sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual-level behavioral interventions to support optimal development of children with sickle cell disease: A systematic review. Hoyt, CR., Hurwitz, S., Varughese, TE., et al.[2023]

In a study of 316 children with sickle cell disease (SCD), the presence of a dedicated Education Liaison (EL) significantly increased the likelihood of children receiving neuropsychological testing (NPT) and educational accommodations, such as Individualized Education Programs (IEPs) and Section 504 plans.

After the intervention, the percentage of children with accommodations rose from 52.8% to 64.6%, demonstrating that integrating an EL into the SCD care team can effectively enhance access to necessary educational support for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education Liaison improves implementation of school accommodations for students with sickle cell disease. McGlynn, MC., Gilliam, A., Pierson, SK., et al.[2023]

The Sickle Cell Transition E-Learning Program (STEP) had a participation rate of only 29% among 183 youths with sickle cell disease, indicating a need for improved engagement strategies.

Completing more modules of STEP was positively correlated with increased disease knowledge, particularly for those who completed three or more modules, which is crucial for self-management during the transition to adult care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Technology to Improve Disease Knowledge Among Adolescents With Sickle Cell Disease: Pilot Study. Saulsberry, AC., Hodges, JR., Cole, A., et al.[2020]

Preschool children with sickle cell disease (SCD) showed significant impairments in working memory and school readiness compared to healthy controls, indicating a need for targeted interventions to support their executive function skills.

The study involved 84 children with SCD and 168 matched controls, revealing that the education level of primary caregivers positively influenced school readiness in SCD patients, suggesting that family background may play a role in their developmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working memory and school readiness in preschool children with sickle cell disease compared to demographically matched controls. Heitzer, AM., Schreiber, JE., Yuan, X., et al.[2023]

A two-part transition program has successfully transitioned 20 patients aged 18 to 27 with sickle cell disease to adult healthcare providers, emphasizing the importance of early preparation for this process.

Patients receive a 'Preparation for Transition' binder at age 13, which is regularly reviewed with families, ensuring a smooth transition to adult care coinciding with significant life milestones like high school graduation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From cradle to commencement: transitioning pediatric sickle cell disease patients to adult providers. Doulton, DM.[2010]

A pilot trial involving 24 children with sickle cell anemia showed that a school intervention program (SIP) significantly improved disease knowledge among both children and teachers compared to routine services (RS).

Children participating in the SIP had fewer school absences, indicating that the educational program not only enhanced understanding of sickle cell anemia but also positively impacted attendance and satisfaction among teachers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled pilot trial of a school intervention for children with sickle cell anemia. Koontz, K., Short, AD., Kalinyak, K., et al.[2019]

The 'Families Taking Control' (FTC) intervention, designed to improve school functioning and health-related quality of life for children with sickle cell disease, did not show significant differences in outcomes compared to the delayed intervention control group after 6 months.

Despite families finding the FTC program acceptable, the study revealed no measurable benefits in terms of academic accommodations, school absences, or overall health-related quality of life for the children involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned From a Randomized Controlled Trial of a Family-Based Intervention to Promote School Functioning for School-Age Children With Sickle Cell Disease. Daniel, LC., Li, Y., Smith, K., et al.[2022]

There is currently no standardized transition program for individuals with sickle cell disease (SCD) moving from pediatric to adult care, leading to increased mortality and morbidity rates.

A review of 30 studies revealed that most were of low quality and high risk of bias, highlighting the need for more rigorous research and better dissemination of effective transition programs for SCD patients aged 12-29.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of transition interventions for young adults with sickle cell disease. Viola, A., Porter, J., Shipman, J., et al.[2023]

A study involving 61 adolescents with sickle cell disease showed that providing skill-based educational handouts significantly improved self-management skills related to healthcare, laundry, housekeeping, and sexual development after the intervention.

The improvements in self-management skills were not solely due to natural maturation, indicating that the educational handouts were effective in enhancing transition readiness for these patients moving from pediatric to adult care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an educational intervention to optimize self-management and transition readiness in young adults with sickle cell disease. Calhoun, CL., Abel, RA., Pham, HA., et al.[2023]

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