Parent Educational Program for Children With Sickle Cell Disease
Condition: Hemoglobin SC Disease; Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell; Hemoglobin SC Disease
Study type: Interventional

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 description: 
      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:

        1. Provide education regarding the learning issues often seen with children with SCD

        2. Provide information regarding special education services in the school system and how
           the parent can obtain academic support for his/her child

        3. Provide information on how to assist the child to better manage homework

        4. Evaluate the child's current level of pain and how pain may affect school attendance

      There will be three evaluation timepoints. At baseline and Year 3, children will undergo a
      neurodevelopmental evaluation, including academic achievement tests. The parent and child
      will complete questionnaires on emotional and behavioral functioning, stress levels, and
      family functioning. At Year 2, the children will complete academic achievement tests, and the
      questionnaires for the parent and child will be repeated.
    

Intervention name(s): Parent Educational Support
Intervention type(s): Behavioral
Intervention description(s): Parents will attend 45-minute educational sessions that will focus on providing them with information regarding SCD and how they can best help their child perform better in school.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sickle Cell Disease; Educational Outcomes; Neurodevelopmental Functioning