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Parent Educational Program for Children With Sickle Cell Disease

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00860782
First Posted: March 12, 2009
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Daniel F. Armstrong, University of Miami
March 10, 2009
March 12, 2009
August 31, 2017
August 2008
May 2016   (Final data collection date for primary outcome measure)
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
Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition [ Time Frame: Measured at baseline and Years 2 and 3 ]
Complete list of historical versions of study NCT00860782 on ClinicalTrials.gov Archive Site
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
Child's emotional and behavioral functioning, parental stress, and family functioning [ Time Frame: Measured at baseline and Years 2 and 3 ]
Not Provided
Not Provided
 
Parent Educational Program for Children With Sickle Cell Disease
Parent Intervention to Improve Academic Success in Children With Sickle Cell Disease
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Hemoglobin SC Disease
  • Anemia, Sickle Cell
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: Low Frequency Support
    Parent Educational Support (once/year for 2 years)
    Intervention: Behavioral: Parent Educational Support
  • Experimental: High Frequency Support
    Parent Educational Support (4 times/year for 2 years)
    Intervention: Behavioral: Parent Educational Support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
August 31, 2018
May 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00860782
20080278
U54HL090569 ( U.S. NIH Grant/Contract )
U54HL090569-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Undecided
Daniel F. Armstrong, University of Miami
University of Miami
National Heart, Lung, and Blood Institute (NHLBI)
Study Director: Daniel Armstrong, PhD University of Miami
University of Miami
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP