School Readiness Intervention for Preschool Children With Sickle Cell

Status Recruiting

Clinical Trial Summary

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 4-6 years old). Primary Objective Assess feasibility and acceptability of an adapted school readiness intervention among preschool children (ages 4-6) 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 (4-6) diagnosed with sickle cell disease. Objective 2: Examine implementation factors (i.e., barriers and facilitators) during post-intervention.

Clinical Trial Description

- 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06367192
Study type	Interventional
Source	St. Jude Children's Research Hospital
Contact	ANDREW HEITZER, PhD
Phone	866-278-5833
Email	referralinfo@stjude.org
Status	Recruiting
Phase	N/A
Start date	May 14, 2024
Completion date	October 2028

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02227472` - Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease
Recruiting	`NCT06301893` - Uganda Sickle Surveillance Study (US-3)
Recruiting	`NCT04398628` - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Completed	`NCT02522104` - Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)	Phase 4
Recruiting	`NCT04688411` - An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease	N/A
Terminated	`NCT03615924` - Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease	Phase 3
Not yet recruiting	`NCT06300723` - Clinical Study of BRL-101 in Severe SCD	N/A
Recruiting	`NCT03937817` - Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Completed	`NCT04917783` - Health Literacy - Neurocognitive Screening in Pediatric SCD	N/A
Completed	`NCT04134299` - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease	N/A
Completed	`NCT02580565` - Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease
Recruiting	`NCT04754711` - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition	N/A
Completed	`NCT04388241` - Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD	N/A
Recruiting	`NCT05431088` - A Phase 2/3 Study in Adult and Pediatric Participants With SCD	Phase 2/Phase 3
Completed	`NCT01158794` - Genes Influencing Iron Overload State
Recruiting	`NCT03027258` - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome	N/A
Withdrawn	`NCT02960503` - Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease	Phase 1/Phase 2
Completed	`NCT02567695` - A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects	Phase 1
Not yet recruiting	`NCT02525107` - Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements	Phase 3
Completed	`NCT02620488` - A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

School Readiness Intervention for Preschool Children With Sickle Cell Disease

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms