RECRUITING

Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Children with sickle cell disease (SCD) exhibit significantly reduced cognitive functioning (often difficulties with attention) compared to peers and siblings without SCD. EndeavorRx (Akili Interactive Labs: Boston, MA) is an FDA-approved home-based, electronic attentional-control training program designed to treat attention problems in youth. Users access EndeavorRx on a tablet device for 25-30 minutes each day, 5 days per week, for 4 weeks. The program involves training in a game-like environment that repeatedly challenges attentional-control abilities and adapts to user performance, becoming more difficult over time as performance improves. This pilot study is examining the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a sample of 20 children with SCD ages 8-16 who are being treated with chronic blood transfusion therapy.

Official Title

Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease

Quick Facts

Study Start:2022-12-20
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05099874

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * diagnosis of SCD
  2. * ages 8-16 years
  3. * maintained on monthly blood transfusions consistently for at least 3 months.
  4. * patients will be proceed to the intervention phase only if they have a T-score \> 75th percentile for Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) or a T-score \> 75th percentile for the Inattention subscale of the ADHD Rating Scale, Fifth Edition (ADHD-RS-V).
  1. * estimated Intelligence Quotient \< 70
  2. * motor, visual, or auditory impairment that prevents computer use
  3. * known diagnosis of a mental health condition that precludes, or takes treatment precedence over, participation in cognitive training
  4. * history of photosensitive seizures
  5. * insufficient English fluency.

Contacts and Locations

Study Contact

Steven J Hardy, Ph.D.
CONTACT
202-476-5000
sjhardy@childrensnational.org

Principal Investigator

Steven J Hardy, Ph.D.
PRINCIPAL_INVESTIGATOR
Children's National Research Institute

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

  • Steven J Hardy, Ph.D., PRINCIPAL_INVESTIGATOR, Children's National Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-20
Study Completion Date2023-12

Study Record Updates

Study Start Date2022-12-20
Study Completion Date2023-12

Terms related to this study

Additional Relevant MeSH Terms

  • Sickle Cell Disease
  • Attention Deficit
  • Cognitive Deficit in Attention