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Parent Educational Program for Children With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT00860782
Recruitment Status : Active, not recruiting
First Posted : March 12, 2009
Last Update Posted : August 31, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hemoglobin SC Disease Anemia, Sickle Cell Behavioral: Parent Educational Support

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Parent Intervention to Improve Academic Success in Children With Sickle Cell Disease
Study Start Date : August 2008
Primary Completion Date : May 2016
Estimated Study Completion Date : August 31, 2018

Arms and Interventions

Arm Intervention/treatment
Experimental: Low Frequency Support
Parent Educational Support (once/year for 2 years)
Behavioral: Parent Educational Support
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.
Experimental: High Frequency Support
Parent Educational Support (4 times/year for 2 years)
Behavioral: Parent Educational Support
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.

Outcome Measures

Primary Outcome Measures :
  1. Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition [ Time Frame: Measured at baseline and Years 2 and 3 ]
    Performance on standardized measure of academic achievement, M=100, SD=15

Secondary Outcome Measures :
  1. Child's emotional and behavioral functioning, parental stress, and family functioning [ Time Frame: Measured at baseline and Years 2 and 3 ]
    Standardized parent report quesionnaires of child adjustment, parent stress, and family function

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children with either HbSS (sickle cell anemia) or HbSβ-thal (hemoglobin S beta thalassemia) who are between 6 and 12 years of age
  • Child's parent or primary caregiver agrees to participate in the study

Exclusion Criteria:

  • Child is monolingual in a language other than English and cannot complete standardized testing in English
  • Parent or caregiver of the child is not fluent in English or Spanish
  • Child has some other developmental disability not related to SCD. This would include Down's syndrome, autism, pervasive developmental disability, cerebral palsy, seizure disorder, consequences of severe prematurity, or a documented closed head injury that resulted in loss of consciousness.
  • Child has been diagnosed with a significant mental health disorder that is not responsive to behavioral or medical management. This includes severe depression, schizophrenia, or bipolar disorder. Children whose mental health problem is effectively treated are eligible for participation.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860782

United States, Florida
Mailman Center for Child Development
Miami, Florida, United States, 33131
Sponsors and Collaborators
University of Miami
National Heart, Lung, and Blood Institute (NHLBI)
Study Director: Daniel Armstrong, PhD University of Miami
More Information

Responsible Party: Daniel F. Armstrong, Professor of Pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT00860782     History of Changes
Other Study ID Numbers: 20080278
U54HL090569 ( U.S. NIH Grant/Contract )
U54HL090569-01 ( U.S. NIH Grant/Contract )
First Posted: March 12, 2009    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Daniel F. Armstrong, University of Miami:
Sickle Cell Disease
Educational Outcomes
Neurodevelopmental Functioning

Additional relevant MeSH terms:
Anemia, Sickle Cell
Hemoglobin SC Disease
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn