Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease
- Conditions
- Anemia, Sickle Cell
- Registration Number
- NCT02857023
- Lead Sponsor
- Steven J. Hardy
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- Diagnosed with sickle cell disease (HbSS, HbSC, or HbS-beta thalassemia).
- 7 to 16 years old.
- An absolute or relative working memory deficit.
- IQ of 70 or greater, as measured via the WISC-V.
- Presence of a caregiver who is willing and capable of providing consistent support and supervision during Cogmed training.
- Visual, motor, or auditory impairment that prevents computer use.
- Insufficient English fluency.
- Started taking or adjusted dose of medication to treat symptoms of ADHD in the last 30 days.
- Unreliable access to a source of electricity to charge an iPad battery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Cogmed feasibility assessed by program completion rates 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).
- Secondary Outcome Measures
Name Time Method Verbal working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Digit Span subtest 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.
Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Picture Span subtest 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.
Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Spatial Span subtest 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.
Trial Locations
- Locations (1)
Children's National Health System
🇺🇸Washington, District of Columbia, United States
Children's National Health System🇺🇸Washington, District of Columbia, United States