NCT05528939Recruiting
Feasibility/Acceptability of Attentional-Control Training in Survivors
FAACTS: Feasibility/Acceptability of Attentional-Control Training in Survivors
Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a multicenter pilot randomized controlled trial, with an active control condition, of the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a cohort of survivors of acute lymphoblastic leukemia or brain tumor ages 8-16 who are \> 1 year from the end of therapy.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 1 Sept 2022
- Start date
- 14 Jun 2023
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Children's National Research Institute
- NCT number
- NCT05528939
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 14 Jun 2023 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A history of photosensitive seizures.
- A mental health condition that precludes, or takes treatment precedence over, participation in the cognitive training.
Other
- A motor, visual, or auditory handicap that prevents computer use.
- Participants identified during the baseline assessment as having a full-scale IQ \< 80, as estimated by WASI-II (Vocabulary and Matrix Reasoning), will not be randomized.
Who the study is looking for
- 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 attention difficulties for at least 30 days prior to enrollment.
- Only patients with a T-score ≥ 75th percentile on the CPT-3 Omission Errors scale or on the BRIEF-2 Cognitive Regulation Index will be randomized.
Age in the registry: 8 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.