Actively Recruiting
Feasibility and Acceptability of Attentional-Control Training Using EndeavorRx in Survivors of Pediatric Acute Lymphoblastic Leukemia and Brain Tumors Aged 8-16
Led by Children's National Research Institute · Updated on 2025-01-10
50
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
Sponsors
C
Children's National Research Institute
Lead Sponsor
S
St. Jude Children's Research Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility, acceptability, and early effectiveness of EndeavorRx, an FDA-approved digital attentional-control training program, in children and teenagers aged 8 to 16 who survived acute lymphoblastic leukemia (ALL) or brain tumors and are at least one year past their treatment. These survivors often face lasting cognitive challenges affecting attention, working memory, and executive functions, which impact daily life, social interactions, school performance, and overall quality of life. This pilot randomized controlled trial aims to study whether EndeavorRx can help improve attention difficulties in this group. Participants will be randomly assigned to either use EndeavorRx, which involves playing an action video game with adaptive difficulty through tasks requiring attention and sensorimotor skills, or to an active control group playing a digital word game designed to match engagement and time spent but targeting different cognitive areas. Both interventions involve sessions lasting 25-30 minutes per day, five days a week, for one month. The study plans to enroll about 50 survivors across three pediatric oncology centers, with 40 participants meeting attention difficulty criteria proceeding to randomization. During the study, children will undergo cognitive testing before and after the intervention period, while parents will complete questionnaires about their child's functioning. Researchers will monitor patient and family interest, adherence to the training schedule, ease of use, and satisfaction with the program. These measures will help assess the feasibility of this training, along with preliminary data on improvements in attention based on performance tests and parent reports. The total involvement includes screening, one month of training, and follow-up assessments.
CONDITIONS
Official Title
Feasibility/Acceptability of Attentional-Control Training in Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 8-16 years at time of screening.
- History of diagnosis of acute lymphoblastic leukemia (ALL) or brain tumor (BT).
- At least 1 year from completion of planned therapy and stable from a disease standpoint.
- Participating child and caregiver are fluent in spoken English.
- Availability of a caregiver who is willing and capable of providing support and supervision during cognitive training.
- Participating child is either not taking any prescribed stimulant medication for attention difficulties or has been prescribed a stable dose of stimulant medication for at least 30 days prior to enrollment.
- Only patients with a T-score 6 75th percentile on the CPT-3 Omission Errors scale or on the BRIEF-2 Cognitive Regulation Index will be randomized.
You will not qualify if you...
- History of photosensitive seizures.
- Motor, visual, or auditory handicap that prevents computer use.
- Mental health condition that precludes, or takes treatment precedence over, participation in cognitive training.
- Full-scale IQ less than 80 as estimated by WASI-II (Vocabulary and Matrix Reasoning) at baseline assessment.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
S
Steven Hardy, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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