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School Readiness Intervention for Preschool Children With Sickle Cell Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
42 Months to 78 Months
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "These sessions will be shared with another researcher for feedback and consistency. * Complete a caregiver interview-If you 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a program to help children with sickle cell disease get ready for school. It is for children ages 3½ to 6½ and their caregivers. Researchers will see how well the program works compared with usual care and whether families find it easy to use and helpful.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The child has any type of sickle cell disease, a blood disorder.
  • The child is ages 3½ to 6½ when joining the study.
  • The child is enrolled in the Sickle Cell Clinical Research Intervention Program (SCCRIP).
  • English is the main language for the child and caregiver.
  • The child and one parent are willing to take part and give permission under the study center’s rules.
  • Caregivers must have a child who meets the disease, age, and SCCRIP enrollment rules above.

Who can't join

  • Caregivers who do not have a child with sickle cell disease, ages 3½ to 6½, who is enrolled in SCCRIP.
  • People who do not speak English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * Diagnosed with sickle cell disease of any genotype. * Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP) * Age 3.5-6.5 years inclusive at the time of enrollment * English as the primary language * Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines Caregiver Participants * Have a child diagnosed with SCD of any genotype between the ages of 3.5-6.5 years and enrolled in SCCRIP * English as the primary language Exclusion Criteria * Do not have a child diagnosed with SCD of any genotype between the ages of 3.5-6.5 years and enrolled in SCCRIP * Non-English speakers

Study sites (1)

TN