Actively Recruiting
Feasibility and Acceptability of Attentional-Control Training Using EndeavorRx in Pediatric Survivors of Acute Lymphoblastic Leukemia or Brain Tumors
Led by Children's National Research Institute · Updated on 2025-01-10
50
Participants Needed
1
Research Sites
N/A
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 preliminary effectiveness of EndeavorRx, an FDA-approved electronic attentional-control training program, in children aged 8 to 16 who have survived acute lymphoblastic leukemia (ALL) or brain tumors and are at least one year past their cancer treatment. These survivors often face long-term cognitive challenges affecting attention, working memory, and executive functioning, which impact daily life, school, and social activities. The study is a multicenter pilot randomized controlled trial aiming to explore this new approach to help improve cognitive difficulties in this group. Participants will be randomly assigned to one of two groups: the EndeavorRx intervention group or an active control group. Those in the EndeavorRx group will complete 25-30 minute digital attentional control training sessions at home, five days per week, for four weeks, totaling 120 training missions. The control group will engage in a digital word game designed to match the intervention's duration and engagement but focuses on cognitive skills not related to attention. Both programs are delivered through digital devices, with training starting within six weeks of baseline testing. During the study, participants will undergo neurocognitive testing before and after the intervention period, while parents will fill out questionnaires about their child's functioning. Researchers will monitor adherence to the training, satisfaction, and ease of use. They will measure changes in attention and executive functioning through tests like the Conners' Continuous Performance Test and the Behavior Rating Inventory of Executive Functioning. Follow-up assessments will occur up to four months post-training to evaluate sustained effects. The study is designed to last several months, including screening, training, and follow-up evaluations.
CONDITIONS
Brief Title
Feasibility/Acceptability of Attentional-Control Training in Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 8 to 16 years at time of screening
- History of acute lymphoblastic leukemia (ALL) or brain tumor diagnosis
- At least 1 year since completing planned cancer therapy and stable disease status
- Child and caregiver fluent in spoken English
- Availability of a caregiver to support and supervise cognitive training
- Child not taking stimulant medication for attention difficulties or on a stable dose for at least 30 days
- T-score at or above 75th percentile on CPT-3 Omission Errors scale or BRIEF-2 Cognitive Regulation Index
You will not qualify if you...
- History of photosensitive seizures
- Motor, visual, or auditory handicap preventing computer use
- Mental health condition that prevents or takes precedence over cognitive training participation
- Full-scale IQ below 80 as estimated by WASI-II during baseline assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for baseline neurocognitive testing and eligibility assessment
Duration - 4 weeks
Participants complete digital attentional control training at home using either the EndeavorRx intervention or an active control video game, designed to assess feasibility and acceptability of the training program.
Daily training sessions, 5 days per week, for 4 weeks (approximately 25-30 minutes per session)
Duration - 4 months after end of training
Participants undergo post-intervention neurocognitive testing and parent questionnaires to assess changes in attention and executive functioning, as well as satisfaction and ease-of-use of the training program. Additional follow-up occurs to monitor sustained effects.
1 post-intervention visit and 1 follow-up visit approximately 4 months later
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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