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

Steven J. Hardy

Status: Completed

Conditions: Anemia, Sickle Cell

Treatments: Behavioral: Cogmed RM

Study type: Interventional

Funder types: Other

Identifiers

NCT02857023

Pro00004421

2013141 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 7 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Cogmed intervention

Experimental group

Description:

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)

Treatment:

Behavioral: Cogmed RM

Cogmed-waitlist control

Experimental group

Description:

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)

Treatment:

Behavioral: Cogmed RM