Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Attention deficit hyperactivity disorder., Attention training, Mobile devices, Brain training
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSustained Attention Control (SAC) Method
Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.
BEHAVIORALScrabble
Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.
Sponsors
National Institute of Mental Health (NIMH)
Think Now Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Meet established Diagnostic and Statistical Manual-5 (DSM-5) criteria for ADHD predominately inattentive or combined subtype with clinically significant levels of impairment, diagnosed by structured clinical interview, the Mini International Neuropsychiatric Interview, and corroborating information 2. Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD 3. No lifetime history of DSM-5 bipolar disorder, psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse, or substance dependence (except nicotine) as assessed with the Mini-International Neuropsychiatric Interview (MINI) 4. Able in the opinion of the investigator to complete all required study procedures.
Exclusion criteria
1. History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia) 2. History of any general medical condition likely to require chronic use of medication with identified Central Nervous System (CNS) effects suspected to alter cognitive performance 3. History of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness 4. Serious oxygen deprivation 5. Current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants 6. Current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity) 7. Current treatment with guanfacine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score | Baseline and 10 weeks | 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. |
| Change From Baseline in Nelson-Denny Reading Test - Comprehension Score | Baseline and 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Inattentive Subscale | Baseline and 10 weeks | 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. |
| Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Hyperactive Subscale | Baseline and 10 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from university clinics, local clinics, private practice clinicians and Attention-Deficit Hyperactivity Disorder (ADHD) groups.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 31 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 10 |
Baseline characteristics
| Characteristic | Total | Control | Active |
|---|---|---|---|
| ADHD Type Combined Type | 19 participants | 8 participants | 11 participants |
| ADHD Type Inattentive Type | 41 participants | 22 participants | 19 participants |
| Age, Continuous | 25.75 Years STANDARD_DEVIATION 5.7 | 27 Years STANDARD_DEVIATION 5.95 | 24.5 Years STANDARD_DEVIATION 5.44 |
| Estimated Intelligence Quotient (IQ) | 108.4 IQ units (typical range 40-160). STANDARD_DEVIATION 11.4 | 107 IQ units (typical range 40-160). STANDARD_DEVIATION 12.1 | 109.8 IQ units (typical range 40-160). STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 63 participants | 31 participants | 32 participants |
| Sex: Female, Male Female | 37 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Male | 26 Participants | 17 Participants | 9 Participants |
| Years of education | 15.25 Years STANDARD_DEVIATION 1.6 | 15.4 Years STANDARD_DEVIATION 1.7 | 15.1 Years STANDARD_DEVIATION 1.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 31 |
| other Total, other adverse events | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 |
Outcome results
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.
Time frame: Baseline and 10 weeks
Population: Completer analysis of all subjects for whom Conners CPT RT Variability was measured at Baseline and after completing 10 weeks of treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active - SAC | Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score | -6.65 score on a scale | Standard Deviation 13.75 |
| Control - Scrabble | Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score | 1.84 score on a scale | Standard Deviation 14.8 |
Comparison: We used a General Linear Model (GLM) with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.p-value: 0.026GLM with repeated measures ANOVA
Comparison: We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.p-value: 0.0075t-test, 1 sided
Comparison: We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.p-value: 0.25t-test, 1 sided
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.
Time frame: Baseline and 10 weeks
Population: Completer analysis of all subjects for whom Nelson-Denny Reading Comprehension was measured at Baseline and after completing 10 weeks of treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active - SAC | Change From Baseline in Nelson-Denny Reading Test - Comprehension Score | 7.36 score on a scale | Standard Deviation 10.26 |
| Control - Scrabble | Change From Baseline in Nelson-Denny Reading Test - Comprehension Score | 1.04 score on a scale | Standard Deviation 6.09 |
Comparison: We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.p-value: 0.014GLM with repeated measures ANOVA
Comparison: We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.p-value: 0.0005t-test, 1 sided
Comparison: We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.p-value: 0.21t-test, 1 sided
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.
Time frame: Baseline and 10 weeks
Population: Completer analysis of all subjects for whom ASRS was measured at Baseline and after completing 10 weeks of treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active - SAC | 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 |
| Control - Scrabble | Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Hyperactive Subscale | -3.13 units on a scale | Standard Deviation 5.42 |
Comparison: We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.p-value: 0.00018GLM with repeated measures ANOVA
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.
Time frame: Baseline and 10 weeks
Population: Completer analysis of all subjects for whom Conners CPT RT Variability was measured at Baseline and after completing 10 weeks of treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active - SAC | 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 |
| Control - Scrabble | Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Inattentive Subscale | -4.17 units on a scale | Standard Deviation 4.67 |
Comparison: We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.p-value: 0.000001GLM with repeated measures ANOVA