What side effects are associated with this type of intervention?

Common treatments for Attention Deficit Disorder (ADD) include pharmacologic options like stimulants (e.g., methylphenidate, amphetamines) and non-stimulants (e.g., atomoxetine, guanfacine). Known side effects of stimulants can include insomnia, decreased appetite, weight loss, increased heart rate, and potential for abuse. Non-stimulants may cause side effects such as fatigue, dry mouth, dizziness, and mood swings. For digital therapeutics like EndeavorRx, side effects are generally minimal but can include mild frustration or eye strain from screen time. Overall, digital therapeutics are considered to have a favorable safety profile compared to pharmacologic treatments.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Attention Deficit Disorder (ADD), including stimulants like methylphenidate (e.g., Ritalin, Concerta) and amphetamines (e.g., Adderall), as well as non-stimulants like atomoxetine (Strattera) and guanfacine (Intuniv). These medications primarily target neurotransmitter activity to improve attention and reduce hyperactivity and impulsivity. In contrast, EndeavorRx represents a novel, non-pharmacological approach, being the first FDA-approved digital therapeutic video game designed to improve attention function in children with ADD. This approval highlights a growing interest in alternative, technology-based interventions for managing ADD symptoms.

What other types of research exist?

Promising, novel alternatives to EndeavorRx for ADD patients include: 1) Mindfulness-based cognitive therapy (MBCT), which combines mindfulness training with cognitive therapy elements and has shown mixed but promising results in clinical trials. 2) Cognitive remediation therapy, which involves computer-based tasks to improve cognitive functions and has demonstrated moderate positive effects in meta-analyses. 3) Viloxazine extended-release capsules, a novel nonstimulant medication that has shown efficacy in improving functional impairments associated with ADHD in children and adolescents.

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Behavioural Intervention

Game-Based Therapy for Attention Skills in Pediatric Cancer Survivors (FAACTS Trial)

N/A

Recruiting

Led By Steven Hardy, Ph.D.

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of training (+4 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new game-based therapy for kids recovering from cancer to help them improve their attention skills.

Who is the study for?

This trial is for children aged 8-16 who survived acute lymphoblastic leukemia or brain tumor, are more than a year post-treatment, and have attention difficulties. They must speak English and have caregiver support. Kids on stable ADHD meds can join; those with certain disabilities, seizures, low IQ, or prioritized mental health conditions cannot.

What is being tested?

The study tests the feasibility and initial effectiveness of a game called EndeavorRx designed to improve attention in pediatric cancer survivors against a control video game. It's a multi-center pilot study where participants are randomly assigned to either the test game or an active control condition.

What are the potential side effects?

Since this trial involves cognitive training games rather than medication, traditional side effects like you'd see with drugs aren't expected. However, there may be risks associated with screen time or frustration from gameplay.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and end of training (+4 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and end of training (+4 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and end of training (+4 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility assessed by EndeavorRx training adherence rates

Feasibility assessed by patient/family interest

Feasibility assessed by reports of technical ease-of-use and satisfaction

Secondary study objectives

Change from baseline executive functioning assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Cognitive Regulation Index (CRI) at end of training

Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)

Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at end of training

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EndeavorRxExperimental Treatment1 Intervention

Children will be asked to begin digital attentional control training at home within 6 weeks of baseline testing and to complete 6 training missions per day (25-30 minutes), 5 days per week, for 4 weeks (total = 120 training missions).

Group II: ControlActive Control1 Intervention

An active control program designed to replicate aspects of the intervention (e.g., regular use of digital device to access fun educational activities) while engaging cognitive skills not particularly involving attention.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Attention Deficit Disorder (ADD) include stimulant medications like methylphenidate and amphetamines, which increase dopamine and norepinephrine levels in the brain to enhance focus and attention. Non-stimulant medications such as atomoxetine work by selectively inhibiting the reuptake of norepinephrine. Behavioral therapies, including Cognitive Behavioral Therapy (CBT) and mindfulness-based interventions, help patients develop coping strategies and improve executive function. Digital therapeutic approaches, like the EndeavorRx video game, aim to improve attention by engaging patients in tasks that require sustained focus and cognitive control. These digital therapies are particularly relevant as they offer a non-pharmacological option that can be integrated into daily routines, providing a complementary approach to traditional treatments.

A Virtual Reality Serious Videogame Versus Online Chess Augmentation in Patients with Attention Deficit Hyperactivity Disorder: A Randomized Clinical Trial.Enhancing attention in neurodegenerative diseases: current therapies and future directions.An Evaluation Approach for the Performance of Dosing Regimens in Attention-Deficit/Hyperactivity Disorder Treatment.