Evaluating an Educational Program Geared for Parents and Aimed at Improving Academic Success in Children With Sickle Cell Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Maria L. Goldman, University of Miami
ClinicalTrials.gov Identifier:
NCT00860782
First received: March 10, 2009
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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 Intervention
Hemoglobin SC Disease
Anemia, Sickle Cell
Behavioral: Parent Educational Support Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Parent Intervention to Improve Academic Success in Children With Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition [ Time Frame: Measured at baseline and Years 2 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child's emotional and behavioral functioning, parental stress, and family functioning [ Time Frame: Measured at baseline and Years 2 and 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: August 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Parents or caregivers of participants will take part in an educational support program once a year for 2 years.
Behavioral: Parent Educational Support Program
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: 2
Parents or caregivers of participants will take part in an educational support program four times a year for 2 years.
Behavioral: Parent Educational Support Program
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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860782

Locations
United States, Florida
Mailman Center for Child Development
Miami, Florida, United States, 33131
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Maria L. Goldman, PsyD University of Miami
Study Director: Daniel Armstrong, PhD University of Miami
  More Information

No publications provided

Responsible Party: Maria L. Goldman, assistant professor of clinical pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT00860782     History of Changes
Other Study ID Numbers: 629, U54HL090569, U54 HL090569-01
Study First Received: March 10, 2009
Last Updated: February 28, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Miami:
Sickle Cell Disease
Educational Outcomes
Neurodevelopmental Functioning

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

ClinicalTrials.gov processed this record on April 23, 2014