ClinicalTrials.gov

History of Changes for Study: NCT02857023
Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease
Latest version (submitted November 21, 2018) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 August 2, 2016 None (earliest Version on record)
2 October 26, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 May 9, 2018 Study Status and Contacts/Locations
4 November 21, 2018 Recruitment Status and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02857023
Submitted Date:  August 2, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: Pro00004421
Brief Title: 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
Secondary IDs: 2013141 [Other Grant/Funding Number: Doris Duke Charitable Foundation]
Open or close this module Study Status
Record Verification: August 2016
Overall Status: Recruiting
Study Start: October 2014
Primary Completion: August 2017 [Anticipated]
Study Completion:
First Submitted: July 28, 2016
First Submitted that
Met QC Criteria:
August 2, 2016
First Posted: August 5, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 2, 2016
Last Update Posted: August 5, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Steven J. Hardy
Responsible Party: Sponsor-Investigator
Investigator: Steven J. Hardy
Official Title: Assistant Professor of Pediatrics and Psychiatry & Behavioral Sciences
Affiliation: Children's National Research Institute
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Anemia, Sickle Cell
Keywords: Neurocognitive
Working memory
Cogmed
Cognitive training
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 134 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 7 Years
Maximum Age: 16 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Steven Hardy, PhD
Email: sjhardy@childrensnational.org
Study Officials: Steven Hardy, PhD
Principal Investigator
Children's National Health System
Locations: United States, District of Columbia
Children's National Health System
[Recruiting]
Washington, District of Columbia, United States, 20010
Contact:Contact: Steven Hardy, PhD sjhardy@childrensnational.org
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services