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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADHD EWM | Experimental | Participants will receive EWM training sessions. |
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| ADHD Placebo | Placebo Comparator | Participants will receive placebo training sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EWM Training | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging Functional Brain Scan using a Seimens 3T Skyra. | fMRI measures of brain activation and functional connectivity - Conventional measures of 'brain activation' are estimated using GLM regression models that fit the fMRI BOLD timeseries data to a model of expected hemodynamic change as elicited by fMRI versions of the executive working memory training task trials. Functional connectivity is assessed using a form of cross-correlation analysis that quantifies how much the entire BOLD timeseries in different brain regions are similar to one another. Our a priori treatment target brain regions are the superior frontal sulcus and mid-lateral prefrontal cortex region of interest. Brain activity and functional connectivity specifically to these regions represent the primary outcome measures of the study. | Change in fMRI measurements from baseline assessment versus 5 weeks at the conclusion of training |
| The experimental executive working memory training tasks | Will examine changes in performance accuracy on the 4 executive working memory training tasks. These are experimental, non-published tasks being tested in this project for the first time. | Change in scores from baseline assessment versus 5 weeks at the conclusion of training |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael C Stevens, PhD | Institute of Living/Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Living/Hartford Hospital | Hartford | Connecticut | 06106 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2024 | |
| Reset | Sep 6, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 25, 2020 | Mar 5, 2021 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2024 | Sep 6, 2024 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Placebo Training | Behavioral | Computerized tasks with comparable engagement that do not tap executive working memory processes |
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