NCT06446284

Target ADHD Executive Working Memory Replication Study

Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The proposed study will replicate target engagement as assessed in the first phase while also determining if it correlates with clinically meaningful improvements in ADHD dysfunction

Detailed description

This proposal is a 3-year clinical trial study replicating an R61 study that targeted brain engagement in 62 ADHD diagnosed adolescents. This study will recruit n=130 adolescents, n=90 ADHD, 40 non-ADHD. The ADHD group will be randomized to a 'sham training' placebo or to train 4 times each week using 4 different EWM exercises that have been combined into the format of a typical cognitive training intervention. Exercise difficulty levels in the active intervention will increase across 5 weeks to continually challenge EWM ability. EWM training will use a novel, remotely-supervised 'at home' computerized training approach that was developed in the Phase I study. This study will attempt to establish a convincing link between the hypothesized targets found in Phase I and ADHD symptom expression. It also will characterize ADHD brain activity or EWM ability changes relative to typical levels seen in the n=40 non-ADHD control group.

Conditions

• ADHD

Interventions

Type	Name	Description
BEHAVIORAL	EWM Training	Training tasks will target Executive Working Memory areas of the brain. Task difficulty will be adaptively increased across the 5 weeks of training based on session-to-session performance.
BEHAVIORAL	Placebo Training	Computerized tasks with comparable engagement that do not tap executive working memory processes

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2024-06-06
• Last updated: 2025-03-04

Locations

1 site across 1 country: United States