Target ADHD Executive Working Memory Study

NCT ID: NCT04795674

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-03-19

Brief Summary

This study will assess whether or not a novel executive working memory training intervention for Attention-Deficit/Hyperactivity Disorder can engage frontoparietal brain network treatment targets and behavioral performance.

Detailed Description

This proposal seeks support for a 2-year milestone-driven R61 initial test of target engagement in n=62 ADHD diagnosed adolescents 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. If R61 EWM training target engagement milestones are met, a 3-year R33 phase will begin. The R33 will replicate target engagement in another randomized placebo-controlled trial of n=90 new ADHD adolescents and attempt to establish a convincing link between the hypothesized targets and ADHD symptom expression. It also will characterize ADHD brain activity or EWM ability changes relative to typical levels seen in an n=40 non-ADHD control group.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ADHD EWM

Participants will receive EWM training sessions.

Group Type: EXPERIMENTAL

EWM Training

Intervention Type: BEHAVIORAL

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.

ADHD Placebo

Participants will receive placebo training sessions.

Group Type: PLACEBO_COMPARATOR

Placebo Training

Intervention Type: BEHAVIORAL

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

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.

Intervention Type: BEHAVIORAL

Placebo Training

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael Stevens

Senior Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael C Stevens, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Living/Hartford Hospital

Locations

Institute of Living/Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HHC-2020-0305

Identifier Type: -

Identifier Source: org_study_id