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

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ClinicalTrials.gov Identifier: NCT02857023
Recruitment Status : Completed
First Posted : August 5, 2016
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
Steven J. Hardy, Children's National Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anemia, Sickle Cell Behavioral: Cogmed RM Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease
Actual Study Start Date : October 2014
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cogmed intervention
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
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.
Experimental: Cogmed-waitlist control
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Cogmed feasibility assessed by program completion rates [ Time Frame: Following 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 Outcome Measures :
  1. Verbal working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Digit Span subtest [ Time Frame: Baseline, 8-10 weeks, 6-month follow-up ]
    Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Digit Span subtest after completing Cogmed.

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

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


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02857023


Locations
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United States, District of Columbia
Children's National Health System
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Steven J. Hardy
Investigators
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Principal Investigator: Steven Hardy, PhD Children's National Health System
More Information
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Responsible Party: Steven J. Hardy, Assistant Professor of Pediatrics and Psychiatry & Behavioral Sciences, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT02857023    
Other Study ID Numbers: Pro00004421
2013141 ( Other Grant/Funding Number: Doris Duke Charitable Foundation )
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018
Keywords provided by Steven J. Hardy, Children's National Research Institute:
Neurocognitive
Working memory
Cogmed
Cognitive training
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn