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| ID | Type | Description | Link |
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| R21MH085842 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute of Mental Health (NIMH) | NIH |
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After decades of Attention Deficit Hyperactivity Disorder (ADHD) intervention research, only two intervention approaches (i.e., psychopharmacology, behavioral treatment) have a "well-established" evidence-base supporting their efficacy for children with ADHD. Both of these interventions have inherent limitations. Recently multiple studies have demonstrated that cognitive training may improve neuropsychological and behavioral functioning in children with ADHD. The magnitude of treatment effects for cognitive training has been comparable to treatment effects for behavioral treatment for ADHD (i.e., small to moderate effect sizes). A limitation of existing cognitive training programs that may limit their efficacy is that each has employed a unifaceted approach. Each intervention program has targeted a single cognitive domain (e.g., working memory). This is problematic since as a group, children with ADHD have multiple areas of cognitive deficit (i.e., working memory, attention, response inhibition, delay aversion, intra-individual variability) and thus a unifaceted intervention does not address the multifaceted array of cognitive dysfunction in children with ADHD. Also, because individuals with ADHD each have unique patterns of cognitive deficits, a unifaceted cognitive training approach may target areas which are non-deficient and miss areas of significant deficit in individual patients depending on their ideographic cognitive profile. The primary goal of the proposed research is to develop and test a multifaceted cognitive training intervention that addresses a comprehensive array of ADHD-related cognitive deficits thereby ensuring that children's unique areas of cognitive deficit are targeted. During Phase I (R21 grant), software and a manual will be developed consisting of four training tasks targeting response inhibition, verbal working memory, attention, and delay aversion. Each task will possess advancing levels of difficulty. On each task, children will receive feedback on performance accuracy as well as on intra-individual variability in reaction times. The software will be pilot tested in Phase I to determine performance thresholds and intervention duration. Also, focus groups will be conducted to obtain patient perceptions of each task's difficulty and interest level. In Phase II (R33 grant), a preliminary randomized clinical trial will be conducted in order to obtain initial estimates of treatment efficacy. Pre-, post-, and follow up outcomes will be collected on a wide range of neuropsychological, behavioral, and academic measures. Effect size estimates across outcomes will be used to guide sample size determinations for future clinical trials of multifaceted cognitive training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifaceted Cognitive Training | Experimental | Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. |
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| Sham Cognitive Training | Sham Comparator | Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifaceted cognitive training | Other | Four computerized training tasks |
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| Measure | Description | Time Frame |
|---|---|---|
| Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale | Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0="Never"; 1="Occasionally"; 2="Often"; 3="Very often"); higher scores indicate higher severity of ADHD symptoms. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reaction Time Variability on go/No-go Task | Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task | 8 weeks |
| Proportion of Words Read Accurately Using the AIMSWEB |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery N Epstein, Ph.D. | Cincinnati Childrens Hospital Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multifaceted Cognitive Training | Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. Multifaceted cognitive training: Four computerized training tasks |
| FG001 | Sham Cognitive Training |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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Number of words read correctly divided by number of words read
| 8 weeks |
Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training Multifaceted cognitive training: Four computerized training tasks |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Multifaceted Cognitive Training | Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. Multifaceted cognitive training: Four computerized training tasks |
| BG001 | Sham Cognitive Training | Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training Multifaceted cognitive training: Four computerized training tasks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale | Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0="Never"; 1="Occasionally"; 2="Often"; 3="Very often"); higher scores indicate higher severity of ADHD symptoms. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Reaction Time Variability on go/No-go Task | Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task | Go/No-Go task data was not available for one participant in the Sham Cognitive Training condition | Posted | Mean | Standard Deviation | milliseconds | 8 weeks |
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| Secondary | Proportion of Words Read Accurately Using the AIMSWEB | Number of words read correctly divided by number of words read | Posted | Mean | Standard Deviation | proportion of words read accurately | 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multifaceted Cognitive Training | Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. Multifaceted cognitive training: Four computerized training tasks | 0 | 22 | 0 | 22 | ||
| EG001 | Sham Cognitive Training | Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training Multifaceted cognitive training: Four computerized training tasks | 0 | 22 | 0 | 22 |
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| Title | Organization | Phone | Extension | |
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| Dr. Jeff Epstein | Cincinnati Children's Hospital Medical Center | 5136368296 | jeff.epstein@cchmc.org |
| 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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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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