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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02857023
Enrollment
91
Registered
2016-08-05
Start date
2014-10-31
Completion date
2018-08-31
Last updated
2018-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Sickle Cell

Keywords

Neurocognitive, Working memory, Cogmed, Cognitive training

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.

Interventions

BEHAVIORALCogmed RM

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.

Sponsors

Steven J. Hardy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cogmed feasibility assessed by program completion ratesFollowing 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

MeasureTime frameDescription
Verbal working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Digit Span subtestBaseline, 8-10 weeks, 6-month follow-upCogmed 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 subtestBaseline, 8-10 weeks, 6-month follow-upCogmed 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 subtestBaseline, 8-10 weeks, 6-month follow-upCogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Spatial Span subtest after completing Cogmed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026