Clinical trial NCT02857023: Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease
Official title: Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia, Sickle Cell
Keywords: Neurocognitive
Working memory
Cogmed
Cognitive training
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 91
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cogmed feasibility assessed by program completion rates
timeFrame: Following completion of Cogmed (approximately 8-10 weeks from baseline)
Secondary outcomes:
measure: Verbal working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Digit Span subtest
timeFrame: Baseline, 8-10 weeks, 6-month follow-up
measure: Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Picture Span subtest
timeFrame: Baseline, 8-10 weeks, 6-month follow-up
measure: Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Spatial Span subtest
timeFrame: Baseline, 8-10 weeks, 6-month follow-up
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
affiliation: Children's National Health System
name: Steven Hardy, PhD
role: PRINCIPAL_INVESTIGATOR
References: