Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease

Conditions
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Anemia, Sickle Cell

Intervention / Treatment
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* Behavioral: Cogmed RM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cogmed intervention<br>Cogmed RM 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) | Behavioral: Cogmed RM<br>* 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.<br>|
| Experimental: Cogmed-waitlist control<br>Cogmed RM 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) | Behavioral: Cogmed RM<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cogmed feasibility assessed by program completion rates | 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). | Following completion of Cogmed (approximately 8-10 weeks from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Digit Span subtest | Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Digit Span subtest after completing Cogmed. | Baseline, 8-10 weeks, 6-month follow-up | 
| Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Picture Span subtest | Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Picture Span subtest after completing Cogmed. | Baseline, 8-10 weeks, 6-month follow-up | 
| Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Spatial Span subtest | Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Spatial Span subtest after completing Cogmed. | Baseline, 8-10 weeks, 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurocognitive, Working memory, Cogmed, Cognitive training