A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study

The Washington University

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Behavioral: Memory Training; Behavioral: General Tutoring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00895154

653

K23HL079073 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The overall goal of this project is to determine the feasibility of conducting a cognitive intervention for children with sickle cell disease.

Full description

The primary aims of this clinical trial are:

1. Determine the effectiveness of targeted learning and memory strategy remediation in students with sickle cell disease and cognitive deficits.
2. Determine if there is improvement in academic achievement after targeted memory strategy remediation.

Enrollment: 21 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sickle cell disease that is confirmed by hemoglobin analysis
• Has a brain magnetic resonance imaging (MRI) document reading by a neuroradiologist
• Cognitive deficits, which are defined by one standard deviation lower than the normal ranges of an age-based standard score in cognitive tests that are evaluated by a psychologist
• Must be a student who will remain in school for at least 2 years
• Must provide informed consent with assent in accordance with the institutional policies (institutional review board approval)

Exclusion criteria

• Known developmental delays (these participants are ineligible because their learning potential may be biased from a prior insult)
• Intelligent quotient is less than 50 (may have impaired learning potential)
• Aphasic (i.e., unable to produce intelligible speech)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

21 participants in 2 patient groups

General Tutoring Group

Active Comparator group

Description:

Participants will receive general tutoring in the subject of his/her choice.

Treatment:

Behavioral: General Tutoring

Tutoring + Memory Training Group

Experimental group

Description:

Participants will receive tutoring and memory training.

Treatment:

Behavioral: Memory Training

Behavioral: General Tutoring