Gameplay Therapy for Attention Deficit Hyperactivity Disorder (ADHD)

(A-GAMES Trial)

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

194 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a video game that adults with ADHD can play at home to help manage their symptoms. The game aims to improve attention and reduce hyperactivity by training the brain. Researchers are studying if this new approach is safe and effective. The Secret Trail of Moon (TSTM) is a virtual reality game designed for cognitive training related to core ADHD symptoms and executive dysfunction.

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 data supports the effectiveness of the ADHD Therapy treatment for ADHD?

Research shows that children with ADHD who received combined treatments, including psychological therapies, were more likely to improve compared to those who received only medication or no therapy. Additionally, home-based behavioral parent training has been effective in reducing ADHD symptoms and disruptive behaviors in children. ^{1 2 3 4 5}

Is Guided ADHD Therapy safe for humans?

The safety of ADHD medications, including those used in Guided ADHD Therapy, is not fully known. There are concerns about possible serious side effects like sudden cardiac death and suicidality, and more research is needed to understand these risks better. ^{6 7 8 9 10}

How is Guided ADHD Therapy different from other ADHD treatments?

Guided ADHD Therapy is unique because it likely combines psychoeducation and psychotherapy with medication, focusing on teaching about ADHD symptoms and treatment options, which is not always emphasized in standard drug treatments. This approach may include cognitive behavioral therapy (CBT) and psychosocial support, offering a more comprehensive and personalized treatment plan compared to medication alone. ^{11 12 13 14 15}

Research Team

Greg Mattingly, MD

Principal Investigator

Midwest Research Group

Eligibility Criteria

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 are within the age range of 22-55 years (for Cohort I) or 18-21 years (for Cohort II).

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.

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

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

Treatment Details

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.

Participant Groups

Group I: ADHD Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Lumos Labs, Inc.

Lead Sponsor

Trials

15

Recruited

16,200+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Thailand pubmed.ncbi.nlm.nih.gov

Attention Deficit Hyperactivity Disorder (ADHD): Clinical Outcomes Measurement Development. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Differences between centers in functional outcome of patients with ADHD after 1 year from the time of diagnosis. [2023]

3. Germany 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Attention-deficit/hyperactivity disorder. [2019]

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Relationship between symptom impairment and treatment outcome in children and adolescents with attention-deficit/hyperactivity disorder: a physician perspective. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. [2022]

7. New Zealand 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Managing the risks of ADHD treatments. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Timely Interventions for Children with ADHD through Web-Based Monitoring Algorithms. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of pediatric attention-deficit/hyperactivity disorder. [2012]

11. Germany pubmed.ncbi.nlm.nih.gov

[Multimodal treatment of adult attention-deficit hyperactivity disorder]. [2021]

12. Spain pubmed.ncbi.nlm.nih.gov

Treatment guidelines for Attention Deficit and Hyperactivity Disorder: A critical review. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

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14. Spain pubmed.ncbi.nlm.nih.gov

Delphi Consensus on Attention Deficit Hyperactivity Disorder (ADHD): evaluation by a panel of experts. [2017]

15. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for adults with attention-deficit/hyperactivity disorder: a review of recent randomized controlled trials. [2021]