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| ID | Type | Description | Link |
|---|---|---|---|
| R43MH101924 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to evaluate the effects of different types of cognitive training on attention in adults with Attention Deficit Hyperactivity Disorder (ADHD) using mobile software on personal mobile devices.
Different types of software-based cognitive training are thought to impact attention via different mechanisms. This study examines the nature of the effects on sustained attention of two different types of mobile software based training. Because the nature of the training method is behavioral, the investigators can not divulge the differences in the training methods and their hypothesized differences in their impact on attention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active - SAC | Experimental | Behavioral learning by using the Sustained Attention Control (SAC) Method's mobile software to increase sustained attention skills and self-awareness of attention control. |
|
| Control - Scrabble | Active Comparator | Behavioral learning using the mobile software game "Scrabble" to exercise word processing and executive control functions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustained Attention Control (SAC) Method | Behavioral | Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score | Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. This is a computerized continuous performance task yielding a measure of reaction time (RT) variability over the duration of the task as an assessment of sustained attention control. Less variability in RT is a sign of better sustained attention control. The scaled scores are T Scores and the range is 0-100. Smaller values represent better performance (i.e. lower variability). Consequently, a negative difference value (Post-Pre) indicates improvement. This measure directly addresses the training target, inconsistent control of sustained attention (the variability in RT over time), and is highly correlated with ADHD. | Baseline and 10 weeks |
| Change From Baseline in Nelson-Denny Reading Test - Comprehension Score | Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The Nelson Denny Reading Comprehension test is a time-limited (20-minute) measure of an important daily life activity that is impaired in ADHD, and impacted by poor sustained attention. The score range is from 0-76 with larger values representing better performance. A larger positive difference value (Post- Pre) indicates an improvement in reading comprehension. | Baseline and 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Inattentive Subscale | Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The ASRS is a scale to evaluate ADHD symptoms in adults. The Inattentive Symptoms Subscale range = 0-36. Higher values are worse. Consequently, a negative difference value indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S Cohen, Ph.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Semel Institute | Los Angeles | California | 90095 | United States |
107 participants were screened and diagnosed and met eligibility criteria to be assigned to treatment. Of these, 22 declined to participate in the treatment stating that they changed their minds and that the treatment and follow-up testing would take too much time, leaving 85 randomized and assigned to treatment.
Participants were recruited from university clinics, local clinics, private practice clinicians and Attention-Deficit Hyperactivity Disorder (ADHD) groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Behavioral learning by using the Sustained Attention Control (SAC) Method's mobile software to increase sustained attention skills and self-awareness of attention control. Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks. |
| FG001 | Control | Behavioral learning using the mobile software game "Scrabble" to exercise word processing and executive control functions. Participants in both groups are told that the study is assessing the impact on cognitive tests from exercising with games that include cognitive processing. Scrabble serves as an active control with similar face value, equivalent usage and experimenter contact. Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The demographics are based on the participants who completed all aspects of the study and for whom all outcome measurements were obtained.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Behavioral training with the Attentional Intelligence Method mobile software to increase sustained attention skills and self-awareness of attention control. Attentional Intelligence Method: Participants use the mobile software, Attentional Intelligence Method, on their mobile device to develop sustained attention control and executive control skills that provides self-awareness of attention control. Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score | Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. This is a computerized continuous performance task yielding a measure of reaction time (RT) variability over the duration of the task as an assessment of sustained attention control. Less variability in RT is a sign of better sustained attention control. The scaled scores are T Scores and the range is 0-100. Smaller values represent better performance (i.e. lower variability). Consequently, a negative difference value (Post-Pre) indicates improvement. This measure directly addresses the training target, inconsistent control of sustained attention (the variability in RT over time), and is highly correlated with ADHD. | Completer analysis of all subjects for whom Conners CPT RT Variability was measured at Baseline and after completing 10 weeks of treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 10 weeks |
|
10 weeks from Baseline.
The treatment and assessment methods have no known risks.
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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 | Active | Behavioral training with the Attentional Intelligence Method mobile software to increase sustained attention skills and self-awareness of attention control. Attentional Intelligence Method: Participants use the mobile software, Attentional Intelligence Method, on their mobile device to develop sustained attention control and executive control skills that provides self-awareness of attention control. Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory V. Simpson | Think Now, Inc. | 4156016522 | greg@think-now.com |
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| 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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| ID | Term |
|---|---|
| D059566 | M Phase Cell Cycle Checkpoints |
| D008722 | Methods |
| ID | Term |
|---|---|
| D059447 | Cell Cycle Checkpoints |
| D002453 | Cell Cycle |
| D002468 | Cell Physiological Phenomena |
| D008938 | Mitosis |
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| Scrabble | Behavioral | Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks. |
|
| Baseline and 10 weeks |
| Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Hyperactive Subscale | Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The ASRS is a scale to evaluate ADHD symptoms in adults. The Hyperactive Symptoms Subscale range = 0-36. Higher values are worse. Consequently, a negative difference value indicates improvement. | Baseline and 10 weeks |
| BG001 | Control | Behavioral training with the mobile software game "Scrabble" to increase concentration. Scrabble: Participants play Scrabble on their mobile device to develop concentration and executive control skills. They use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Estimated Intelligence Quotient (IQ) | Estimate of IQ based on the composite score of the Wechsler Abbreviated Scale of Intelligence (WASI-II). | Mean | Standard Deviation | IQ units (typical range 40-160). |
|
| Years of education | Mean | Standard Deviation | Years |
|
| ADHD Type | The ADHD Type (Inattentive or Combined) is based on the clinical diagnosis using the Adult ADHD Self Report Scale and structured interview. | Data were missing from 3 participants, leaving a total of 60. The determination of ADHD Type breaks the Overall participants into two groups. | Number | participants |
|
| Active - SAC |
Behavioral learning by using the Sustained Attention Control (SAC) Method's mobile software to increase sustained attention skills and self-awareness of attention control. Sustained Attention Control (SAC) Method: Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks. |
| OG001 | Control - Scrabble | Behavioral learning using the mobile software game "Scrabble" to exercise word processing and executive control functions. Scrabble: Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks. |
|
|
|
| Primary | Change From Baseline in Nelson-Denny Reading Test - Comprehension Score | Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The Nelson Denny Reading Comprehension test is a time-limited (20-minute) measure of an important daily life activity that is impaired in ADHD, and impacted by poor sustained attention. The score range is from 0-76 with larger values representing better performance. A larger positive difference value (Post- Pre) indicates an improvement in reading comprehension. | Completer analysis of all subjects for whom Nelson-Denny Reading Comprehension was measured at Baseline and after completing 10 weeks of treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 10 weeks |
|
|
|
|
| Secondary | Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Inattentive Subscale | Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The ASRS is a scale to evaluate ADHD symptoms in adults. The Inattentive Symptoms Subscale range = 0-36. Higher values are worse. Consequently, a negative difference value indicates improvement. | Completer analysis of all subjects for whom Conners CPT RT Variability was measured at Baseline and after completing 10 weeks of treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 10 weeks |
|
|
|
|
| Secondary | Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Hyperactive Subscale | Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The ASRS is a scale to evaluate ADHD symptoms in adults. The Hyperactive Symptoms Subscale range = 0-36. Higher values are worse. Consequently, a negative difference value indicates improvement. | Completer analysis of all subjects for whom ASRS was measured at Baseline and after completing 10 weeks of treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 10 weeks |
|
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Control | Behavioral training with the mobile software game "Scrabble" to increase concentration. Scrabble: Participants play Scrabble on their mobile device to develop concentration and executive control skills. They use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks. | 0 | 31 | 0 | 31 | 0 | 31 |
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| D048750 |
| Cell Nucleus Division |
| D002455 | Cell Division |
| D055614 | Genetic Phenomena |
| D008919 | Investigative Techniques |
We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.
| t-test, 1 sided |
| 0.0005 |
| Superiority |
| We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test. | t-test, 1 sided | 0.21 | Superiority |