Clinical Trial: Parent Educational Program for Children With Sickle Cell Disease
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Parent Intervention to Improve Academic Success in Children With Sickle Cell Disease
Brief Summary: Children with sickle cell disease (SCD) are at risk for central nervous system (CNS) complications, which may affect academic achievement. This study will evaluate an educational support program for parents that aims to improve academic achievement in children with SCD.
Detailed Summary:
SCD is an inherited blood disorder that is caused by an abnormal type of hemoglobin—the protein in red blood cells that carries oxygen to tissues. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." Children with SCD are also at risk for a variety of CNS complications, including various types of stroke and increased blood flow to the brain. These conditions affect neuropsychological performance and academic achievement. In children with SCD, there may also be a relationship between CNS complications, behavioral problems, family environment stressors, and pain symptoms. For example, children with SCD-related CNS complications have a higher risk of developing behavioral problems than children without SCD. In turn, behavioral problems are associated with high levels of family conflict and can be a significant stressor for families coping with SCD. This kind of stress can then lead to increased difficulty in dealing with SCD symptoms, particularly pain, for the child. This study will evaluate an educational support program for parents of children with SCD, conducted either once a year or four times a year, in terms of the program's effect on children's academic achievement. In addition, study researchers will also evaluate the program's effect on behavioral difficulties, pain frequency, and the family environment.
This study will enroll children with HbSS (sickle cell anemia) or HbSb-thal (hemoglobin S beta thalassemia) SCD. Parents or caregivers of participants will be randomly assigned to attend the educational support program meetings either once a year or four times a year for 2 years. The educational meetings with the parent/caregiver will be 45 minutes long and will cover the following four main areas:
- Prov
Sponsor: University of Miami
Current Primary Outcome: Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition [ Time Frame: Measured at baseline and Years 2 and 3 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Child's emotional and behavioral functioning, parental stress, and family functioning [ Time Frame: Measured at baseline and Years 2 and 3 ]
Original Secondary Outcome: Same as current
Information By: University of Miami
Dates:
Date Received: March 10, 2009
Date Started: August 2008
Date Completion: June 2017
Last Updated: June 29, 2016
Last Verified: June 2016
