560 Participants Needed

Guided ADHD Therapy for ADHD

(GAMES Trial)

Recruiting at 14 trial locations
BS
Overseen ByBob Schafer, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

If you are currently taking medications like methylphenidate or amphetamine for ADHD, you may need to stop them if you and the study doctor agree it's appropriate. If you're on non-stimulant ADHD medications, you cannot participate in the trial.

What data supports the effectiveness of the ADHD Therapy treatment?

Research shows that patients who received a combination of treatments for ADHD were more likely to improve compared to those who received only medication or psychological treatment alone. This suggests that a guided ADHD therapy, which may involve multiple approaches, could be effective in improving ADHD symptoms.12345

Is Guided ADHD Therapy safe for humans?

The safety of ADHD medications, which may be similar to Guided ADHD Therapy, is not fully known. There are concerns about side effects, including serious issues like heart problems and suicidal thoughts, but more research is needed to understand these risks better.678910

How does Guided ADHD Therapy differ from other ADHD treatments?

Guided ADHD Therapy is unique because it combines cognitive behavioral therapy (CBT) with parent management training (PMT), focusing on self-instructional and self-management skills to reduce ADHD symptoms and improve behavior. This approach is particularly effective when combined with medication and addresses both the child's and parents' roles in managing ADHD.511121314

Research Team

AC

Ann Childress, MD

Principal Investigator

Clinical Research of Southern Nevada, LLC

Eligibility Criteria

Adults aged 22-55 with ADHD, an IQ score of at least 80, and a clinician-rated ADHD-RS total score ≥28 can join. They must speak English, not be on certain ADHD medications or agree to stop them if they are, and have daily access to a wireless network. People with severe psychiatric disorders, recent substance abuse, motor conditions that prevent game playing, or who've used similar digital therapies recently cannot participate.

Inclusion Criteria

I am either male or female.
Ability to comply with all the testing and study requirements
I have been diagnosed with ADHD, either combined or inattentive type, by a trained clinician.
See 6 more

Exclusion Criteria

You are not allowed to use certain drugs that affect your brain and behavior during the study, unless they are specifically prescribed by your doctor.
You have had a problem with alcohol or drugs in the past year.
I have a history of seizures or significant tics, not including febrile seizures.
See 13 more

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
  • Control Therapy
Trial OverviewThe trial is testing the safety and effectiveness of a new at-home digital therapy for adults with ADHD. It's game-based and compared against a control therapy. Participants will use this intervention in their own environment to see if it helps manage their symptoms better than existing methods.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ADHD TherapyExperimental Treatment1 Intervention
Group II: Control TherapyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lumos Labs, Inc.

Lead Sponsor

Trials
15
Recruited
16,200+

Findings from Research

A systematic review of 35 studies on ADHD treatments showed that all recommended interventions led to significant improvements in core symptoms, with reductions in symptoms ranging from 20% to 86%.
The studies, primarily using DSM-criteria-based rating scales, demonstrated a consistent pattern of improvement across various treatment types, suggesting that measuring symptom reduction within one year could serve as an effective outcome measure for ADHD care.
Considerations and evidence for an ADHD outcome measure.Woods, D., Wolraich, M., Pierce, K., et al.[2019]
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.
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]
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.
Managing the risks of ADHD treatments.Schneider, BN., Enenbach, M.[2021]

References

Attention Deficit Hyperactivity Disorder (ADHD): Clinical Outcomes Measurement Development. [2019]
Considerations and evidence for an ADHD outcome measure. [2019]
Sensitivity of tests to assess improvement in ADHD symptomatology. [2021]
Differences between centers in functional outcome of patients with ADHD after 1 year from the time of diagnosis. [2023]
A comparison of preferred treatment outcomes between children with ADHD and their parents. [2015]
Managing the risks of ADHD treatments. [2021]
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]
European guidelines on managing adverse effects of medication for ADHD. [2022]
Timely Interventions for Children with ADHD through Web-Based Monitoring Algorithms. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Pharmacotherapy of pediatric attention-deficit/hyperactivity disorder. [2012]
11.United Statespubmed.ncbi.nlm.nih.gov
Cognitive behavior therapy for adults with attention-deficit/hyperactivity disorder: a review of recent randomized controlled trials. [2021]
A survey of music therapy methods and their role in the treatment of early elementary school children with ADHD. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
The Texas Children's Medication Algorithm Project: Report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Attention-Deficit/Hyperactivity Disorder. Part II: Tactics. Attention-Deficit/Hyperactivity Disorder. [2019]
[Treatment effects of combined cognitive behavioral therapy with parent training in hyperkinetic syndrome]. [2019]