Cognitive Rehabilitation in Sickle Cell Disease
Status: | Completed |
---|---|
Conditions: | Cognitive Studies, Anemia |
Therapuetic Areas: | Hematology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 8 - 16 |
Updated: | 5/5/2014 |
Start Date: | October 2012 |
End Date: | June 2014 |
Contact: | Taryn Allen, MA |
Email: | taryn.allen@duke.edu |
Phone: | 919-681-0022 |
Cognitive Rehabilitation of Children With Sickle Cell Disease: A Pilot Study
The majority of school-age children with sickle cell disease (SCD) experience neurocognitive
deficits, even in the absence of stroke. In particular, deficits in attention and working
memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal
of the present proposal is to address feasibility and compliance of a novel computerized
cognitive training program, Cogmed. Pilot data will also be collected to establish
preliminary efficacy. Twenty-four children meeting initial age and diagnostic criteria will
be identified and approached about participation by their attending physician during
regularly-scheduled SCD clinic visits. Baseline assessments will include a brief measure of
intellectual functioning, a brief cognitive testing battery evaluating processing speed and
working memory, in addition to questionnaires regarding behavior and quality of life.
Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist
control (n=12). Participants enrolled in the computerized CT program will be asked to
complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week).
Following completion of the program, children and their parents will be asked to return to
clinic for a follow-up visit. After a five to eight-week waiting period, children in the
waitlist condition will also be asked to return to clinic for a second visit. Following this
assessment, participants initially enrolled in the waitlist will be offered an opportunity
to participant in the intervention. If interested, they will follow the same intervention
protocol described above. These children will return to clinic for a third visit following
completion of the intervention. Compliance rate and its confidence interval will be
calculated for the overall study population. A t-test for binomial proportion with
continuity correction will be used to examine whether the compliance rate is lower than the
target. Participants' change in criterion outcomes will be evaluated (i.e., those
neurocognitive measures such as attention, executive functioning and working memory, that
are most closely related to the trained tasks).
deficits, even in the absence of stroke. In particular, deficits in attention and working
memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal
of the present proposal is to address feasibility and compliance of a novel computerized
cognitive training program, Cogmed. Pilot data will also be collected to establish
preliminary efficacy. Twenty-four children meeting initial age and diagnostic criteria will
be identified and approached about participation by their attending physician during
regularly-scheduled SCD clinic visits. Baseline assessments will include a brief measure of
intellectual functioning, a brief cognitive testing battery evaluating processing speed and
working memory, in addition to questionnaires regarding behavior and quality of life.
Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist
control (n=12). Participants enrolled in the computerized CT program will be asked to
complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week).
Following completion of the program, children and their parents will be asked to return to
clinic for a follow-up visit. After a five to eight-week waiting period, children in the
waitlist condition will also be asked to return to clinic for a second visit. Following this
assessment, participants initially enrolled in the waitlist will be offered an opportunity
to participant in the intervention. If interested, they will follow the same intervention
protocol described above. These children will return to clinic for a third visit following
completion of the intervention. Compliance rate and its confidence interval will be
calculated for the overall study population. A t-test for binomial proportion with
continuity correction will be used to examine whether the compliance rate is lower than the
target. Participants' change in criterion outcomes will be evaluated (i.e., those
neurocognitive measures such as attention, executive functioning and working memory, that
are most closely related to the trained tasks).
Inclusion Criteria:
- 1) Children with a diagnosis of SCD (all genotypes)
- 2) a T-score ≥75th percentile on either the Metacognition or Executive Composite of
the BRIEF; and/or
- 3) a standard score ≥1 standard deviation below the mean (<90) on the tasks of
executive function or WM from the Cogstate (mean=100; SD=10)
Exclusion Criteria:
- 1) Estimated IQ ≤ 75), or motor, visual, or auditory handicap that prevents computer
use;
- 2) a diagnosis of depression or a pervasive developmental disorder (by history);
- 3) clinical stroke (via record medical history); or
- 4) non-English fluency.
We found this trial at
1
site
Click here to add this to my saved trials