Children's National Health System
Washington D.C., District of Columbia, 20010, United States
NCT Number: NCT02857023
Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD). These deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. Despite widespread recognition of neurocognitive deficits, there are no treatments shown to maintain or recover functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a standard intervention used to stabilize and recover functioning in individuals with accidental or disease-related brain injury. Recent advances in technology have led to the development of computerized CT programs. This study seeks to assess the feasibility and efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed). Feasibility will be assessed by examining participation, retention, and program completion rates, as well as feedback from a feasibility and acceptability questionnaire and a brief qualitative interview. Participants will also complete assessments of attention, working memory, and academic fluency at baseline and immediately following the intervention. A final assessment will be conducted 6 months after the conclusion of the intervention to evaluate the stability of treatment effects.
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Notify Me7 year–16 year
All sexes
Interventional
Not applicable
Washington D.C., District of Columbia, 20010, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cogmed consists of 12 increasingly challenging exercises (completed over 25 sessions spanning 5-8 weeks) that target skills involving visuo-spatial and verbal working memory.
Time frame: Following completion of Cogmed (approximately 8-10 weeks from baseline)
Feasibility will be determined by examining the proportion of the sample that completes at least 20 Cogmed sessions (i.e., 80% of the program) within the allotted time frame (10-week maximum).
Time frame: Baseline, 8-10 weeks, 6-month follow-up
Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Digit Span subtest after completing Cogmed.
Time frame: Baseline, 8-10 weeks, 6-month follow-up
Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Picture Span subtest after completing Cogmed.
Time frame: Baseline, 8-10 weeks, 6-month follow-up
Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Spatial Span subtest after completing Cogmed.
Steven J. Hardy
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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