Cognitive Training for ADHD

Overseen By Michael Kofler, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Seizure disorder, Psychosis, Bipolar, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new computer-based program called Central Executive Training (CET) to assist children with ADHD. CET aims to enhance working memory and inhibitory control, which are often challenging for those with ADHD. The study includes two versions of CET, each focusing on different aspects of executive function. Children aged 8-12 diagnosed with ADHD and experiencing noticeable working memory issues are ideal candidates for this trial. As an unphased trial, it provides a unique opportunity for children to potentially improve their cognitive skills through innovative training.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this protocol is safe for youth with ADHD?

Research shows that Central Executive Training (CET) is a computer-based program designed to help children with ADHD improve memory and self-control. This training reduces ADHD symptoms and boosts school performance. Studies have provided strong initial evidence that CET significantly and lastingly enhances organizational skills in school for children with ADHD.

Regarding safety, clear data on any negative effects specifically from CET programs is lacking. However, the study is in the "not applicable" phase, indicating that the program's safety is still under investigation. Generally, computer-based training like CET is considered low-risk because it doesn't involve medication or physical treatments.

Overall, while promising evidence supports its effectiveness, more research is needed to fully understand the safety of these training programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Central Executive Training (CET) for ADHD because it offers an innovative approach focusing on cognitive skills rather than medication. Traditional ADHD treatments often rely on stimulant medications, but CET targets specific brain functions directly. The CET-Working Memory (WM) arm aims to improve the brain's ability to hold and manipulate information, while the CET-Behavioral Inhibition (BI) arm enhances self-control and decision-making. By directly training these executive functions, CET could provide a non-pharmacological option that minimizes side effects and addresses core cognitive challenges in ADHD.

What evidence suggests that this trial's treatments could be effective for ADHD?

Research shows that Central Executive Training (CET) can help children with ADHD improve skills needed for focusing and controlling behavior. Studies have found that CET boosts memory and reduces ADHD symptoms like being easily distracted and overly active. For example, one study showed that CET improved memory and school performance. Another study found that the positive effects on attention and behavior lasted for several months. In this trial, participants will receive either CET focused on Working Memory or CET focused on Inhibitory Control. Both approaches effectively aid areas often affected by ADHD. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for children aged 8-12 with ADHD, as confirmed by clinical interviews and teacher/parent ratings. They must have below-average working memory but no severe neurological issues, intellectual disability (IQ < 78), or conditions like psychosis that could affect participation. Non-English speakers are excluded.

Inclusion Criteria

The parent and teacher ratings for ADHD-RS-5 or BASC-3 Attention Problems/Hyperactivity subscales were in the clinical/borderline range based on age and gender.

This study is looking for people with ADHD who have a working memory that is below average or lower than normal on at least one pre-treatment WM test.

Children ages 8-12 with principal ADHD diagnoses (via Kiddie Schedule for Affective Disorders semi-structured clinical interviewing (K-SADS)

Exclusion Criteria

Conditions requiring acute intervention, e.g., active suicidality

Gross neurological, sensory, or motor impairment

History of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (substance use, disruptive mood dysregulation, intermittent explosive, reactive attachment)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Central Executive Training (CET) for ADHD, focusing on working memory and inhibitory control

6-8 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of ADHD symptoms and cognitive performance

2-4 months

Follow-up testing sessions

What Are the Treatments Tested in This Trial?

Interventions

• Central Executive Training: Inhibitory Control
• Central Executive Training: Working Memory

Trial Overview The study tests Central Executive Training (CET) targeting different executive functions in the brain to improve attention and memory in kids with ADHD. It's a computerized program developed from expert feedback, designed to help manage symptoms of ADHD through cognitive exercises.

How Is the Trial Designed?

Group I: CET-Working Memory (WM) Experimental Treatment 1 Intervention

Central Executive Training: Working Memory

Group II: CET-Behavioral Inhibition (BI) Active Control 1 Intervention

Central Executive Training: Inhibitory Control

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7384295/

A Randomized Controlled Trial of Central Executive Training ... Results support the use of CET for treating executive function deficits and targeting ADHD behavioral symptoms in children with ADHD.

2. psycnet.apa.org psycnet.apa.org/record/2020-53939-004

A randomized controlled trial of central executive training ... A randomized controlled trial of central executive training (CET) versus inhibitory control training (ICT) for ADHD. Publication Date. Aug 2020. Publication ...

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.1034722/full

Does central executive training and/or inhibitory control ... Contrary to our hypotheses, the CET and ICT groups demonstrated equivalent reductions in emotion dysregulation and maintenance of effects.

4. psy.fsu.edu psy.fsu.edu/clc/Publications/nihms-1785129.pdf

Central Executive Training for ADHD: Effects on Academic ... Conclusions: Results across the two trials provide strong support for the efficacy of CET for. ADHD, and are consistent with model-driven hypotheses that ...

5. researchgate.net researchgate.net/publication/343367661_A_randomized_controlled_trial_of_central_executive_training_CET_versus_inhibitory_control_training_ICT_for_ADHD

(PDF) A Randomized Controlled Trial of Central Executive ... CET-related gains were maintained at 2–4 month follow-up; ICT-related gains were maintained for attention problems but not hyperactivity/ ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11110569/

Working memory and inhibitory control deficits in children with ... A randomized controlled trial of central executive training (CET) versus inhibitory control training (ICT) for ADHD. J Consulting Clin ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10615842/

Central executive training for ADHD: Impact on organizational ... Results provide strong initial evidence CET produces robust and lasting downstream improvements in school-based organizational skills for children with ADHD ...

8. nature.com nature.com/articles/s41380-023-02000-7

Computerized cognitive training in attention-deficit ... This comprehensive and well-powered meta-analysis found no evidence to support the use of CCT in its current forms as a stand-alone treatment ...

9. simplypsychology.org simplypsychology.org/organizational-skills-in-adhd-training.html

Improving Organizational Skills in ADHD: Central ... This study provides initial evidence that targeting underlying working memory deficits using CET can improve ADHD-related organizational skills.

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735813001219

Do programs designed to train working memory, other ... Collectively, ADHD-related central executive deficits appear to be a particularly promising target for intervention given (a) large magnitude effect size ...