Trial Outcomes & Findings for Training Attentional Awareness and Control in ADHD (NCT NCT02489279)
NCT ID: NCT02489279
Last Updated: 2019-07-10
Results Overview
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.
COMPLETED
NA
107 participants
Baseline and 10 weeks
2019-07-10
Participant Flow
Participants were recruited from university clinics, local clinics, private practice clinicians and Attention-Deficit Hyperactivity Disorder (ADHD) groups.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
41
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
10
|
Baseline Characteristics
Data were missing from 3 participants, leaving a total of 60. The determination of ADHD Type breaks the Overall participants into two groups.
Baseline characteristics by cohort
| Measure |
Active
n=32 Participants
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.
|
Control
n=31 Participants
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.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.5 Years
STANDARD_DEVIATION 5.44 • n=32 Participants
|
27 Years
STANDARD_DEVIATION 5.95 • n=31 Participants
|
25.75 Years
STANDARD_DEVIATION 5.7 • n=63 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=32 Participants
|
14 Participants
n=31 Participants
|
37 Participants
n=63 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=32 Participants
|
17 Participants
n=31 Participants
|
26 Participants
n=63 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
31 participants
n=31 Participants
|
63 participants
n=63 Participants
|
|
Estimated Intelligence Quotient (IQ)
|
109.8 IQ units (typical range 40-160).
STANDARD_DEVIATION 10.7 • n=32 Participants
|
107 IQ units (typical range 40-160).
STANDARD_DEVIATION 12.1 • n=31 Participants
|
108.4 IQ units (typical range 40-160).
STANDARD_DEVIATION 11.4 • n=63 Participants
|
|
Years of education
|
15.1 Years
STANDARD_DEVIATION 1.5 • n=32 Participants
|
15.4 Years
STANDARD_DEVIATION 1.7 • n=31 Participants
|
15.25 Years
STANDARD_DEVIATION 1.6 • n=63 Participants
|
|
ADHD Type
Inattentive Type
|
19 participants
n=30 Participants • Data were missing from 3 participants, leaving a total of 60. The determination of ADHD Type breaks the Overall participants into two groups.
|
22 participants
n=30 Participants • Data were missing from 3 participants, leaving a total of 60. The determination of ADHD Type breaks the Overall participants into two groups.
|
41 participants
n=60 Participants • Data were missing from 3 participants, leaving a total of 60. The determination of ADHD Type breaks the Overall participants into two groups.
|
|
ADHD Type
Combined Type
|
11 participants
n=30 Participants • Data were missing from 3 participants, leaving a total of 60. The determination of ADHD Type breaks the Overall participants into two groups.
|
8 participants
n=30 Participants • Data were missing from 3 participants, leaving a total of 60. The determination of ADHD Type breaks the Overall participants into two groups.
|
19 participants
n=60 Participants • Data were missing from 3 participants, leaving a total of 60. The determination of ADHD Type breaks the Overall participants into two groups.
|
PRIMARY outcome
Timeframe: Baseline and 10 weeksPopulation: Completer analysis of all subjects for whom Conners CPT RT Variability was measured at Baseline and after completing 10 weeks of treatment.
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.
Outcome measures
| Measure |
Active - SAC
n=29 Participants
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.
|
Control - Scrabble
n=30 Participants
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.
|
|---|---|---|
|
Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score
|
-6.65 score on a scale
Standard Deviation 13.75
|
1.84 score on a scale
Standard Deviation 14.80
|
PRIMARY outcome
Timeframe: Baseline and 10 weeksPopulation: Completer analysis of all subjects for whom Nelson-Denny Reading Comprehension was measured at Baseline and after completing 10 weeks of treatment.
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.
Outcome measures
| Measure |
Active - SAC
n=25 Participants
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.
|
Control - Scrabble
n=23 Participants
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.
|
|---|---|---|
|
Change From Baseline in Nelson-Denny Reading Test - Comprehension Score
|
7.36 score on a scale
Standard Deviation 10.26
|
1.04 score on a scale
Standard Deviation 6.09
|
SECONDARY outcome
Timeframe: Baseline and 10 weeksPopulation: Completer analysis of all subjects for whom Conners CPT RT Variability was measured at Baseline and after completing 10 weeks of treatment.
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.
Outcome measures
| Measure |
Active - SAC
n=28 Participants
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.
|
Control - Scrabble
n=30 Participants
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.
|
|---|---|---|
|
Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Inattentive Subscale
|
-3.29 units on a scale
Standard Deviation 5.34
|
-4.17 units on a scale
Standard Deviation 4.67
|
SECONDARY outcome
Timeframe: Baseline and 10 weeksPopulation: Completer analysis of all subjects for whom ASRS was measured at Baseline and after completing 10 weeks of treatment.
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.
Outcome measures
| Measure |
Active - SAC
n=28 Participants
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.
|
Control - Scrabble
n=30 Participants
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.
|
|---|---|---|
|
Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Hyperactive Subscale
|
-2.54 units on a scale
Standard Deviation 5.34
|
-3.13 units on a scale
Standard Deviation 5.42
|
Adverse Events
Active
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place