School Readiness Intervention for Preschool Children With Sickle Cell Disease

Обзор

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.

Подробное описание

* Group randomization- Parent and child will be randomly selected (like the flip of a coin) to receive either the school readiness intervention or the standard school resources. * Attend virtual classroom program sessions- If the participant is in the school readiness group, the caregiver, will attend about 8 weeks of sessions virtually with a teacher 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. 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. The caregiver will be asked for suggestions and how satisfied with the program. * Complete assessments - Caregiver and child 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.

Вмешательства

• Поведенческое The adapted Kids in Transition to School Intervention
  An intensive, school readiness intervention designed to improve preschoolers' social skills, early literacy, numeracy, and self-regulation skills at high risk for academic difficulties. The intervention is delivered virtually over 8 weeks with caregivers and intentionally occurs over the summer when there is a gap in preschool services.
• Поведенческое Standard school resources
  Information about local preschool programs and age appropriate books for children will be provided.

Первичные конечные точки

• Feasibility of Intervention Measure [Срок оценки: Collected immediately after the intervention]
• Acceptability of Intervention Measure [Срок оценки: Collected immediately after the intervention]

Вторичные конечные точки (6)

• Bracken School Readiness Assessment - 3rd Edition [Срок оценки: Baseline and Collected immediately after the intervention]
• Woodcock Johnson Tests of Achievement - Fourth Edition [Срок оценки: Baseline and Collected immediately after the intervention]
• NIH Toolbox Flanker Test [Срок оценки: Baseline and Collected immediately after the intervention]
• Head-Toes-Knees-Shoulders Revised [Срок оценки: Baseline and Collected immediately after the intervention]
• Behavior Rating Inventory of Executive Functioning Preschool or Child [Срок оценки: Baseline and Collected immediately after the intervention]
• The Parenting Scale [Срок оценки: Baseline and Collected immediately after the intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• St. Jude Children's Research Hospital — Memphis

Публикации

• Heitzer AM, Kang E, Tamboli M, Brazley-Rodgers M, Kolb-Quinn A, Carroll Y, Conklin HM, King AA, Hankins JS, Pears K, Fernandez ME. Adapting a school readiness intervention for children with sickle cell disease: an intervention mapping for adaptation approach. Front Public Health. 2026 Jul 6;14:1862943. doi: 10.3389/fpubh.2026.1862943. eCollection 2026. PMID 42524380

Идентификаторы

NCT: NCT06367192 · SKITS2 · K23HL166697

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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