Parent Educational Program for Children With Sickle Cell Disease

Not Applicable

Completed

• Conditions: Hemoglobin SC Disease; Anemia, Sickle Cell
• Interventions: Behavioral: Parent Educational Support

• Registration Number: NCT00860782
• Lead Sponsor: University of Miami

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.

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-12
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Annual Parent Intervention (API) Group	Parent Educational Support	Participants in this group will receive the parent educational support intervention once a year for 2 years.
Quarterly Parent Intervention (QPI) Group	Parent Educational Support	Participants in this group will receive the parent educational support intervention quarterly (4 times a year) for 2 years.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mailman Center for Child Development; 🇺🇸 Miami, Florida, United States