Recruiting

ADHD

Sponsor:

Hartford Hospital

Code:

NCT06446284

Conditions

ADHD

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Interventions

EWM Training

Placebo Training

Study Details

Brief 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

Conditions

ADHD

Study ID

NCT06446284

Start date

Dec 1, 2023

Status verified date

Mar, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Inclusion Criteriia:

  • Diagnosis of ADHD
  • English speaking
  • Right-handed
  • >5th grade reading level
  • >80 IQ level

Exclusion Criteria:

  • Braces, metal or implant devices
  • Brain abnormality, neurological disorder
  • TBI or loss of consciousness>30 minutes
  • Diagnosis of Psychosis, Bipolar Disorder, ASD, PTSD, OCD, SUD, Tourette's Disorder

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ADHD EWM

Participants will receive EWM training sessions.

placebo comparator: ADHD Placebo

Participants will receive placebo training sessions.

Interventions

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.

Placebo Training

Computerized tasks with comparable engagement that do not tap executive working memory processes

Primary outcome measure

  • Magnetic Resonance Imaging Functional Brain Scan using a Seimens 3T Skyra. [ Time Frame: Change in fMRI measurements from baseline assessment versus 5 weeks at the conclusion of training ]
  • Experimental executive working memory training tasks - Reaction Time [ Time Frame: Change in scores from baseline assessment versus 5 weeks at the conclusion of training ]
  • Experimental executive working memory training tasks - Performance Accuracy [ Time Frame: Change in scores from baseline assessment versus 5 weeks at the conclusion of training ]

Central Contacts and Locations

Central contacts

Karen L Kesten, MS

8605457776Karen.kesten@hhchealth.org

Abigail Sullivan, MS

8605457363Abigail.sullivan@hhchhealth.org

Locations

Institute of Living/Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Karen L Kesten, MS

860-545-7776Karen.kesten@hhchealth.org

Kelly Scheidel, BA

(860) 545-7363Kelly.Scheidel@hhchealth.org

Principal Investigator:

Michael C Stevens, PhD

More Information

Sponsor

Hartford Hospital

Last update posted

Mar 4, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2025-03-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.