NCT01123863

The Brigance Assessment Of Individual Neurodevelopment In Young Children With Sickle Cell Disease- 2

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 248 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 4 Years
• Healthy volunteers: Accepted

Summary

A preliminary study was conducted involving 88 three-year-old children with sickle cell disease (SCD) who were followed at the St. Jude Children's Research Hospital Sickle Cell Center. They were offered developmental screening with the Brigance Preschool Screen-II test during their regular clinic visits from January 2006 to August 2008. Data from this work showed that 50% of 3 year old children with SCD had low developmental screening scores. In addition, the low scores were found to be associated with less parental education and with speech deficits. However they were not associated with sickle cell genotype and hemoglobin level. The primary goal of this study is to prospectively administer Brigance Preschool Screen -II to 3 year old children with SCD and 3 year old children without SCD who come from similar socioeconomic backgrounds and compare the results between the two groups.

Detailed description

The primary objective of this study is to compare development in 3 year old children with SCD who are not on any treatment to age matched healthy controls using pass/fail rate for the Brigance Preschool Screen II. Secondary objectives: 1. To compare the raw scores of the Brigance Preschool Screen II between SCD and control groups. 2. To compare the pass/fail rate and the raw scores between SCD patients who are not on any treatment and those who are being treated with hydroxyurea. 3. To compare the pass/fail rate and the raw scores between SCD patients on hydroxyurea treatment and the healthy controls 4. To assess the influence of medical factors on the Brigance Preschool Screen II performance in children with SCD. 5. To assess the influence of socioeconomic factors on the Brigance Preschool II results in children with SCD and controls.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
OTHER	Brigance Preschool Screen -II	Three-year-old children with SCD who are followed at the St. Jude Children's Research Hospital Sickle Cell Center will be offered developmental screening with the Brigance Preschool Screen II during their regular clinic visits. Along with the screening test, socioeconomic data will be collected using a short questionnaire. Families will be asked to participate in this study by allowing us to collect their test results, medical information and socioeconomic data to compare with data collected from the control group. Parents who decline participation in this study will still be offered the Brigance Preschool Screen II as part of their child's clinical care.
OTHER	Brigance Preschool Screen -II	Children in the Control Group will be given the Brigance preschool Screen-II Screening at the daycare they attend. The STARR coordinators have selected four daycare centers that have agreed to serve as control group sites. The family will be asked not to respond or aid the child during the assessment. One parent/guardian will fill out the Socioeconomic Data Collection Form while the examiner works with the child. The screening requires the child to give both verbal and non-verbal responses. The examiner records responses on the Three-Year-Old Child Data Sheet for the Brigance Preschool Screen-II. After the screening is complete the examiner collects the Socioeconomic Data Collection Form from the parent and leaves the room to score the assessment and write recommendations. The examiner then returns to the clinic room to discuss the results with the parent/guardian.

Timeline

• Start date: 2010-05-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2010-05-14
• Last updated: 2018-06-28

Locations

1 site across 1 country: United States