Game-Based Therapy for Attention Skills in Pediatric Cancer Survivors
(FAACTS Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's National Research Institute
Must be taking: Stimulants
Disqualifiers: Photosensitive seizures, Motor handicap, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking stimulant medication for attention difficulties, you must have been on a stable dose for at least 30 days before joining the trial.
What data supports the effectiveness of the treatment EndeavorRx for attention skills in pediatric cancer survivors?
The Cognitive Remediation Program (CRP), a similar treatment, showed improved attention and academic achievement in childhood cancer survivors, suggesting that game-based therapies like EndeavorRx might also help improve attention skills in this group.
12345Is game-based therapy safe for pediatric cancer survivors?
The research on computerized cognitive training, like Captain's Log, in childhood cancer survivors shows it is generally safe and well-accepted, with participants experiencing improvements in attention and memory.
12467How is the treatment EndeavorRx different from other treatments for attention skills in pediatric cancer survivors?
EndeavorRx is unique because it is a game-based digital therapy specifically designed to improve attention skills, making it different from traditional medication or therapy. It is the first FDA-approved video game treatment for ADHD, offering a fun and engaging way to help children improve their focus and attention.
89101112Eligibility Criteria
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.Inclusion Criteria
I am between 8 and 16 years old.
I have a caregiver available to help me with cognitive training.
Participating child and caregiver are fluent in spoken English
+4 more
Exclusion Criteria
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
My mental health condition needs immediate treatment over participating in any cognitive training.
A motor, visual, or auditory handicap that prevents computer use
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive EndeavorRx or active control intervention, with 25-30 minute sessions per day, 5 days per week, for 4 weeks
4 weeks
Home-based, daily sessions
Follow-up
Participants are monitored for changes in attention and executive functioning, with assessments at 4 months post-training
16 weeks
Assessments at 4 months post-training
Participant Groups
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.
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.
EndeavorRx is already approved in United States for the following indications:
🇺🇸 Approved in United States as EndeavorRx for:
- Improving attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's National HospitalWashington, United States
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Who Is Running the Clinical Trial?
Children's National Research InstituteLead Sponsor
George Washington UniversityCollaborator
National Cancer Institute (NCI)Collaborator
Children's Hospital of PhiladelphiaCollaborator
St. Jude Children's Research HospitalCollaborator
References
Translating methylphenidate's efficacy on selective and sustained attentional deficits to those reported in childhood cancer survivors: A qualitative review. [2023]Whilst an increasing number of children survive previously incurable cancers of the central nervous system (CNS), associated treatments often result in significant neurocognitive late effects. Methylphenidate provides some signs of alleviating cognitive difficulties in different pediatric groups; however, a minimal amount of systematic work has explored its effectiveness isolated to vulnerable attentional domains. The current review aimed to explore the effectiveness of methylphenidate isolated to two attentional domains (sustained and selective attention)-with an aim to substantiate its utility in childhood cancer survivors. Five databases were comprehensively searched for relevant articles. A purpose-developed tool was used to assess each study's robustness and research quality. Eleven out of 1,865 identified articles were included within the review. Studies drew upon five clinical populations. Individual attentional domains demonstrate variation in their response to methylphenidate. Sustained attention demonstrated the most consistent benefit of methylphenidate, reported largely in attention-deficit/hyperactivity disorder (ADHD) groups. Gains in selective attention and higher-order cognitive functions appeared to follow initial gains in sustained attention. Childhood cancer survivors report greater gains in selective attention compared to sustained attention. Higher doses may yield greater benefit for children with more diffuse attentional deficits. There is a need to improve the validity of current attentional measures before further methylphenidate trials are conducted.
Impact of attention on social functioning in pediatric medulloblastoma survivors. [2018]Parent-reported attention problems have been associated with social functioning in a broad sample of pediatric cancer survivors.
The potential utility of parent-reported attention screening in survivors of childhood cancer to identify those in need of comprehensive neuropsychological evaluation. [2020]Survivors of childhood cancer are at risk for neuropsychological late effects, yet identifying those in need of evaluation and obtaining needed services can be challenging for the medical team. Finding time- and cost-effective screening measures that can be used to identify children in need of evaluation is a clinical priority. Our objective was to investigate the association between parent-rated attention problems and related neuropsychological impairments in childhood cancer survivors as a means of identifying those at high risk for difficulties.
A multicenter, randomized clinical trial of a cognitive remediation program for childhood survivors of a pediatric malignancy. [2022]Survivors of childhood cancer whose malignancy and/or treatment involved the central nervous system may demonstrate a consistent pattern of neurocognitive deficits. The present study evaluated a randomized clinical trial of the Cognitive Remediation Program (CRP). Participants were 6- to 17-year-old survivors of childhood cancer (N = 161; 35% female, 18% Hispanic, 10% African American, 64% Caucasian, 8% other) who were at least 1 year off treatment and who manifested an attentional deficit. They were enrolled at 7 sites nationwide. Two thirds of the participants were randomly assigned to cognitive remediation. All participants were assessed using a battery of academic achievement/neurocognitive tests and parent/teacher measures of attention. The CRP resulted in parent report of improved attention and statistically significant increases in academic achievement. Effect sizes were modest but were comparable with those for other clinical trials of brain injury rehabilitation and for psychological interventions in general. The CRP is presented as a potentially beneficial treatment for many survivors of pediatric cancer. Long-term clinical significance remains unproven. Further work is needed to improve effect sizes and treatment compliance and to address the needs of other populations with pediatric brain injury.
The Effects of Attention Problems on Psychosocial Functioning in Childhood Brain Tumor Survivors: A 2-Year Postcraniospinal Irradiation Follow-up. [2018]To examine the psychosocial outcomes and impact of attention problems in survivors of pediatric brain tumor.
Computerized cognitive training in survivors of childhood cancer: a pilot study. [2023]The objective of the current study was to pilot a computerized cognitive training program, Captain's Log, in a small sample of survivors of childhood cancer. A total of 9 survivors of acute lymphoblastic leukemia and brain tumors with attention and working memory deficits were enrolled in a home-based 12-week cognitive training program. Survivors returned for follow-up assessments postintervention and 3 months later. The intervention was associated with good feasibility and acceptability. Participants exhibited significant increases in working memory and decreases in parent-rated attention problems following the intervention. Findings indicate that home-based, computerized cognitive intervention is a promising intervention for survivors with cognitive late effects; however, further study is warranted with a larger sample.
Sluggish cognitive tempo profiles in survivors of childhood cancer as compared to children with attention-deficit/hyperactivity disorder. [2023]Neurocognitive late effects including problems with attention have been reported in pediatric oncology survivors. While some researchers have characterized these late effects as similar to symptoms of attention-deficit/hyperactivity disorder, inattentive presentation (ADHD-I), there remains some controversy as to whether these concerns in oncology patients are best conceptualized according to an ADHD-I or sluggish cognitive tempo (SCT) framework. The aim of this study was to describe SCT symptoms in children with ADHD-I or oncology diagnoses; identify groups of SCT symptoms among children with brain tumors (BT), acute lymphoblastic leukemia (ALL), or ADHD-I; and identify whether specific SCT profiles are associated with these diagnoses.
A Pilot Study of the Efficacy of a Cognitive Training Based on Board Games in Children with Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial. [2020]Objective: The main aim of this study was to prove the efficacy of an intervention based on board games on executive functions (EFs) and clinical symptoms in children with attention-deficit/hyperactivity disorder (ADHD). Materials and Methods: A nonblinded randomized controlled trial was conducted with a sample of children with a diagnosis of ADHD (diagnosed by psychiatrists and clinical psychologists in a mental health center). Children were randomly allocated by matching age and sex, into two groups: experimental EF training group (n = 13; mean [M]age = 9.46, standard deviation [SD] = 1.20; boys = 53.8%) or a wait-list control group (n = 14; Mage = 9.50, SD = 1.09; boys = 71.4%). Measures assessed individually at pretest, posttest, and follow-up intervention included EFs and clinical symptoms. Results: Analysis of covariance repeated measures analysis showed that linguistic short-term memory, F(1,28) = 7.45, p = 0.02, and conduct problems, F(1,28) = 12.51, p = 0.00, significantly improved with larger effects in the board games training group after intervention when compared to the wait-list group. Although nonsignificant effects were reported at the follow-up, large effect sizes were actually found. Conclusion: Although future studies are needed, the results of this study highlight the importance of board games and its efficacy as a possible therapeutic and/or preventive intervention on ADHD.
A pilot study of the efficacy of a computerized executive functioning remediation training with game elements for children with ADHD in an outpatient setting: outcome on parent- and teacher-rated executive functioning and ADHD behavior. [2022]This pilot study tested the short- and long-term efficacy (9 weeks follow-up) of an executive functioning (EF) remediation training with game elements for children with ADHD in an outpatient clinical setting, using a randomized controlled wait-list design. Furthermore, in a subsample, that is, those treated with methylphenidate, additive effects of the EF training were assessed.
Effects of game-based digital therapeutics on attention deficit hyperactivity disorder in children and adolescents as assessed by parents or teachers: a systematic review and meta-analysis. [2023]Attention-deficit/hyperactivity disorder (ADHD) is a childhood-onset disorder characterized by pharmacological and non-pharmacological interventions. Despite the available treatment options and prevention measures, conventional treatments have several limitations. Digital therapeutics (DTx) like EndeavorRx® is an emerging alternative to overcome these limitations. EndeavorRx® is the first FDA-approved, game-based DTx approved for the treatment of pediatric ADHD. We investigated the effects of game-based DTx in randomised controlled trials (RCTs) on children and adolescents with ADHD. In this systematic review and meta-analysis, we searched PubMed, Embase, and PsycINFO databases up to January 2022. The protocol was registered (CRD42022299866). The assessor was defined as parents and teachers. The primary outcome was differences in inattention reported by the assessor, and the secondary outcome was differences in hyperactivity and hyperactivity/impulsivity reported by the assessor and the relative comparisons between game-based DTx, medicine, and control with indirect meta-analysis. Game-based DTx improved inattention more than the control upon assessment by assessors (standard mean difference (SMD) 0.28, 95% confidence interval (CI) 0.14-0.41; SMD 0.21, 95% CI 0.03-0.39, respectively), while medication improved inattention more than game-based DTx (SMD - 0·62, 95% CI - 1·04 to - 0·20) upon assessment by the teacher. Game-based DTx improved hyperactivity/impulsivity than the control upon assessment by assessors (SMD 0.28, 95% CI 0.03-0.53; SMD 0.30, 95% CI 0.05-0.55, respectively), and medication improved hyperactivity/impulsivity significantly than game-based DTx upon assessment by the teacher. Hyperactivity has not been reported extensively. As a result, game-based DTx had a more significant effect than the control, however medication was more effective.
A serious game for children with Attention Deficit Hyperactivity Disorder: Who benefits the most? [2018]The aim of the current study was to identify which subgroups of children with Attention Deficit Hyperactivity Disorder (ADHD) benefitted the most from playing a Serious Game (SG) intervention shown in a randomized trial to improve behavioral outcomes.
"Braingame Brian": Toward an Executive Function Training Program with Game Elements for Children with ADHD and Cognitive Control Problems. [2015]In the area of childhood attention-deficit hyperactivity disorder, there is an urgent need for new, innovative, and child-focused treatments. A computerized executive functioning training with game elements aimed at enhancing self-control was developed. The first results are promising, and the next steps involve replication with larger samples, evaluating transfer of training effects to daily life, and enhancing motivation through more gaming elements.