Parent Educational Program for Children With Sickle Cell Disease

NCT00860782 | Completed DMC

• 3 other identifiers: 20080278U54HL090569U54HL090569-01
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemoglobin SC Disease; Anemia, Sickle Cell

Keywords

Sickle Cell Disease; Educational Outcomes; Neurodevelopmental Functioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Child's emotional and behavioral functioning, parental stress, and family functioning

  Measured at baseline and Years 2 and 3

Study Arms (2)

Annual Parent Intervention (API) Group

EXPERIMENTAL

Participants in this group will receive the parent educational support intervention once a year for 2 years.

Behavioral: Parent Educational Support

Quarterly Parent Intervention (QPI) Group

EXPERIMENTAL

Participants in this group will receive the parent educational support intervention quarterly (4 times a year) for 2 years.

Behavioral: Parent Educational Support

Interventions

Parent Educational Support BEHAVIORAL

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.

Annual Parent Intervention (API) Group; Quarterly Parent Intervention (QPI) Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mailman Center for Child Development

Miami, Florida, 33131, United States

Location

MeSH Terms

Conditions

Hemoglobin SC Disease; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Daniel Armstrong, PhD

  University of Miami

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 12, 2009
• Study Start: August 1, 2008
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)