RecruitingNot ApplicableNCT06770010

Advancing Feasibility and Acceptability of Digital Cognitive Rehabilitation in Sickle Cell Disease

Advancing Feasibility and Acceptability of Digital Cognitive Rehabilitation in Sickle Cell (ALL IN)


Sponsor

Children's National Research Institute

Enrollment

50 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single site nonrandomized pilot clinical trial of the feasibility, acceptability, and efficacy of a combination treatment involving digital Cogmed working memory skills training, social support components, and memory strategy training to improve adherence to Cogmed in youth with sickle cell disease ages 7-16 years.


Eligibility

Min Age: 7 YearsMax Age: 16 Years

Inclusion Criteria3

  • Diagnosis of sickle cell disease (any genotype).
  • Between ages 7-16 years old.
  • Patients will only enter the treatment phase if they score >1 SD below the normative mean on at least one standardized working memory assessment (i.e., Digit Span or Spatial Span subtests) or demonstrate a relative weakness in working memory (>1 SD below the estimated IQ).

Exclusion Criteria5

  • Motor, visual, or auditory impairment that prevents computer use.
  • Diagnosis of a mental health condition that precludes, or takes treatment precedence over, participation in the cognitive training.
  • History of photosensitive seizures.
  • Insufficient English fluency.
  • Recent initiation or dose adjustment of a stimulant medication to treat attention problems (< 30 days).

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Interventions

BEHAVIORALCogmed+

Cogmed is a home-based, digital working memory training program compatible with tablet devices. The program, designed for children ages 7 and older, consists of engaging cognitive exercises that target skills involving visuospatial and verbal working memory. An essential component of Cogmed training involves assignment of an intervention "coach" who has access to detailed data on the user's training data. Families will have videoconference meetings once per week with an intervention coach to review progress, provide feedback and answer any questions that arise during treatment. In addition, participants' coaching calls will be supplemented with direct instruction on the use of memory strategies. Social support interventions will also be provided involving three primary approaches: (1) multi-family Cogmed Kickoff social events; (2) social incentives; and (3) peer navigator support.


Locations(1)

Children's National Hospital

Washington D.C., District of Columbia, United States

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NCT06770010


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