Gameplay Therapy for Attention Deficit Hyperactivity Disorder (ADHD)

(A-GAMES Trial)

Not currently recruiting at 4 trial locations

Overseen By Bob Schafer, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Lumos Labs, Inc.

Must be taking: ADHD medication

Must not be taking: Psychoactive drugs

Disqualifiers: PTSD, Schizophrenia, Bipolar, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, game-based digital therapy for managing ADHD symptoms at home. The researchers aim to assess the safety and effectiveness of this treatment for adults whose ADHD isn't fully controlled by current medication. Suitable participants have a confirmed ADHD diagnosis, are on medication but still experience symptoms, and have access to a computer or smart device with internet.

As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could enhance ADHD management.

Will I have to stop taking my current medications?

The trial requires that you continue using your current ADHD medication if it is FDA approved and has been stable for at least 4 weeks before screening. However, you should not be using any other psychoactive drugs that might affect the study.

What prior data suggests that this digital therapy is safe for adults with ADHD?

Research shows that ADHD treatments, especially those combining behavior therapy and medication, are generally safe and helpful for most people. Studies have found that ADHD medications can lower the risk of injuries and reduce hospital visits for both mental and physical health issues. Importantly, evidence indicates that these treatments can reduce suicidal behavior. Although some concerns about heart-related issues exist, they are rare. Overall, current evidence supports that ADHD treatments are usually well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Guided ADHD Therapy because it offers a personalized approach to managing ADHD, unlike standard treatments like medication and behavioral therapy. This new therapy uses guided techniques to tailor strategies directly to the individual's needs, potentially enhancing focus and self-regulation in ways that generic methods might not. By honing in on specific challenges faced by each individual, this therapy could lead to more effective and sustainable improvements in attention and behavior for those with ADHD.

What evidence suggests that this digital therapy is effective for ADHD?

Research has shown that digital therapies can help manage ADHD symptoms. One study found that digital therapy improved attention and behavior in children. For adults, cognitive-behavioral therapy (CBT) reduced ADHD symptoms for those already on medication. Additionally, dialectical behavioral therapy (DBT) moderately reduced symptoms and improved quality of life in adults. These findings suggest that digital therapy, such as the game-based ADHD Therapy under study in this trial, might effectively manage ADHD symptoms in adults. ^{6 7 8 9 10}

Who Is on the Research Team?

Greg Mattingly, MD

Principal Investigator

Midwest Research Group

Are You a Good Fit for This Trial?

Adults aged 18-55 with ADHD, who can follow English instructions and have stable internet access for at-home digital therapy. Participants must be on steady ADHD medication but still experience symptoms. Excluded are those with recent substance abuse, high depression scores, or a history of seizures among other criteria.

Inclusion Criteria

You have been using a certified medication to address your ADHD for the past 4 weeks and it has not sufficiently regulated your condition.

You have attained a minimum score of 24 on the Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) comprising DSM 5 Inattentive Symptoms, DSM 5 Hyperactive - Impulsive Symptoms and ADHD Index subscales.

You must be able to routinely access a wireless network with your devices.

Exclusion Criteria

Your family member or close friend is already participating in this study.

You have participated in another clinical trial within the last three months before screening.

Your vision is so poor that you cannot play the game or it affects your ability to play the game properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an at-home, game-based digital therapy for ADHD

9 weeks

At-home therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ADHD Therapy

Trial Overview The trial is testing an at-home game-based digital therapy to see if it helps adults manage their ADHD symptoms better. It's designed for those whose current medications aren't fully effective.

How Is the Trial Designed?

Group I: ADHD Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Lumos Labs, Inc.

Lead Sponsor

Trials

15

Recruited

16,200+

Published Research Related to This Trial

ADHD medications, particularly stimulants, are effective treatments but can lead to various side effects, making it crucial to understand their prevalence and management strategies.

The review highlights the importance of recognizing and managing adverse events associated with ADHD medications to ensure safe and effective treatment for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing the risks of ADHD treatments. Schneider, BN., Enenbach, M.[2021]

In a study of 1429 ADHD patients across 16 centers, those receiving combined treatment (medication and psychological therapy) showed a significantly higher improvement rate (65.5%) compared to those on methylphenidate alone (54.4%), psychological treatment alone (53.4%), or no therapy (40.5%).

There was considerable variation in treatment outcomes between centers, with the expected probability of improvement ranging from 47.7% to 61.2%, suggesting that center-specific approaches and attitudes significantly influence patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences between centers in functional outcome of patients with ADHD after 1 year from the time of diagnosis. Cartabia, M., Finazzi, S., Bonati, M.[2023]

A review of 43 studies involving around 7000 children found that common adverse drug reactions (ADRs) from ADHD medications included decreased appetite, gastrointestinal pain, and headaches, primarily reported by children or their parents.

Most studies reported low rates of serious ADRs, but many children dropped out due to serious reactions, suggesting that the actual incidence of serious ADRs may be higher, highlighting the need for long-term safety studies on ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. Aagaard, L., Hansen, EH.[2021]

The automated trigger algorithm successfully identified potential adverse events in 8% of parent-reported ADHD assessments, leading to timely clinician reviews and changes in care plans for 46% of actionable alerts.

Patients with triggered alerts showed significantly worsened ADHD severity scores prior to the alerts, indicating that the algorithm effectively highlighted those needing immediate attention and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timely Interventions for Children with ADHD through Web-Based Monitoring Algorithms. Oppenheimer, J., Ojo, O., Antonetty, A., et al.[2020]

The safety profile of ADHD medications is not fully understood, with concerns about both older and newer medications potentially causing serious adverse effects, including sudden cardiac death and suicidality.

A review by the European Network for Hyperkinetic Disorders highlighted that while some adverse effects may be minimal or similar to risks in untreated individuals, further research is needed to clarify the safety risks associated with ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. Graham, J., Banaschewski, T., Buitelaar, J., et al.[2022]

In a study of 73 children with ADHD and disruptive behaviors, home-based behavioral parent training significantly reduced the severity of disruptive behaviors and ADHD symptoms compared to a waiting list and standard care, with effect sizes indicating moderate to large improvements.

The training was particularly effective in addressing oppositional-defiant disorder symptoms, suggesting that it can be a valuable intervention for children who continue to struggle after traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based parent training for school-aged children with attention-deficit/hyperactivity disorder and behavior problems with remaining impairing disruptive behaviors after routine treatment: a randomized controlled trial. Nobel, E., Hoekstra, PJ., Agnes Brunnekreef, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11162428/

Improving the efficacy and effectiveness of evidence-based ... Overall, commercialized BPT and homegrown BPT have been found to be effective in improving the functioning of children with ADHD and their ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10943890/

One-year follow-up of the effectiveness and mediators of ... The long-term effectiveness of CBT in medicated ADHD adults with residual symptoms was further confirmed. The CBT conceptual model was verified ...

3. nature.com nature.com/articles/s41598-024-73934-3

Clinical study on the intervention effect of digital therapy ... To evaluate the efficacy and safety of digital therapy for children aged 6 to 12 years with attention deficit hyperactivity disorder (ADHD).

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178125001994

Dialectical behavioral therapy for adult attention deficit ... Meta-analysis showed DBT moderately reduced ADHD symptoms (SMD = -0.51 [-0.76, -0.25]) and improved quality of life (SMD = 0.41 [0.15, 0.66]) compared to ...

5. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-021-03046-8

Long-term effectiveness of behavioural intervention in ... Behavioural intervention can effectively improve behaviour management and relieve symptoms in children with ADHD. These effects lasted at least six months.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19621975/

Efficacy and safety limitations of attention-deficit ... Findings of the Multimodal Treatment of Children With ADHD study suggest that the combination of behavioural and medical therapy may benefit most patients.

7. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7340a1.htm

Attention-Deficit/Hyperactivity Disorder Diagnosis, ... Among adults who reported taking a stimulant medication, 71.5% reported difficulty getting their ADHD prescription filled during the previous 12 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6697582/

Risks and benefits of ADHD medication on behavioral ... Four studies, including three within-individual studies, found ADHD medication was significantly associated with 9–32% reduced risk of injury (39–41, 44), with ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2816499

Attention-Deficit/Hyperactivity Disorder Medications and ... The use of ADHD medication was associated with fewer hospitalizations for both psychiatric and nonpsychiatric morbidity and lower suicidal behavior.

10. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-medications-used-treat-attention

Safety Review Update of Medications used to treat ADHD The inferential value of not finding an association is tempered by the fact that there were only seven serious cardiovascular events during ADHD ...