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.

Study Overview

• Status: Completed
• Conditions: Anemia, Sickle Cell; Hemoglobin SC Disease
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33131
      • Mailman Center for Child Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Annual Parent Intervention (API) Group; Participants in this group will receive the parent educational support intervention once a 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: Quarterly Parent Intervention (QPI) Group; Participants in this group will receive the parent educational support intervention quarterly (4 times a 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition	Performance on standardized measure of academic achievement, M=100, SD=15	Measured at baseline and Years 2 and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child's emotional and behavioral functioning, parental stress, and family functioning	Standardized parent report quesionnaires of child adjustment, parent stress, and family function	Measured at baseline and Years 2 and 3

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Study Director: Daniel Armstrong, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2008
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 10, 2009
• First Submitted That Met QC Criteria: March 10, 2009
• First Posted (Estimate): March 12, 2009

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Sickle Cell Disease; Educational Outcomes; Neurodevelopmental Functioning
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell; Hemoglobin SC Disease
• Other Study ID Numbers: 20080278; U54HL090569 (U.S. NIH Grant/Contract); U54HL090569-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Following final data analysis and dissemination, the SAP and ICF will be shared with investigators requesting these materials.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No