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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| University of California, Berkeley | OTHER |
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The purpose of this clinical trial is to evaluate the effects of mobile app digital therapies on cognitive function and symptoms in adults diagnosed with ADHD.
The study is a randomized, parallel group, controlled trial of two mobile app digital therapies. The study will consist of initial screening tests and diagnostics to determine eligibility, followed by outcome measure testing and treatment. On Day 0, the Baseline visit will occur wherein the pre-treatment (baseline) assessments will be conducted on-site. The Treatment period (Day 1 to Day 49) will involve using the digital therapy at home. Midpoint (Day 25) assessments will be conducted on-site to assess key outcomes. Final Post-Treatment (Day 50) assessments will be conducted on-site to assess key outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC-A | Active Comparator | UC-0A is a digital mobile app intervention that uses cognitive control skills for task performance. The intervention is used once a day, 5 days a week, for 7 weeks. |
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| UC-N | Active Comparator | UC-0N is a digital mobile app intervention that uses cog control skills for problem solving. The intervention is used once a day, 5 days a week, for 7 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UC-A | Device | Mobile app digital therapy |
| |
| UC-N |
| Measure | Description | Time Frame |
|---|---|---|
| Conners Continuous Performance Task (CPT3) - HRT Std (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment) | Conners CPT-HRT Std (Hit Reaction Time Standard Deviation) is the standard deviation of the reaction time of hits to target stimuli over the entire test. The calculation of the difference between Baseline and Midpoint (Mid-treatment) in the Conners HRT Std is HRT Std at Day 25 minus HRT Std at Day 0; and the difference between Baseline and Endpoint (Post-treatment) is HRT Std at Day 50 minus HRT Std at Day 0. Higher scores represent more variability in responding, reflecting poorer sustained attention control. A negative change in score represents improvement in sustained attention control. | Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50) |
| Measure | Description | Time Frame |
|---|---|---|
| Nelson Denny Reading Comprehension Test (NDRT) - Reading Comprehension Scaled Score (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment) | NDRT - Reading Comprehension Scaled Score (Reading Comp) is the total comprehension score for the full 20-minute, 36-item reading test based on the number of correct answers. The calculation of the difference between Baseline and Midpoint (Mid-treatment) in the NDRT Reading Comp is Reading Comp at Day 25 minus Reading Comp at Day 0; and the difference between Baseline and Endpoint (Post-treatment) is Reading Comp at Day 50 minus Reading Comp at Day 0. Higher scores represent more correct answer reflecting better comprehension. A positive change in score represents improvement in reading comprehension. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bilder, Ph.D | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Berkeley | Berkeley | California | 94720 | United States | ||
| UCLA Semel Institute |
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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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| Device |
Mobile app digital therapy |
|
| Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50) |
| Barkley Adult ADHD Rating Scale (BAARS-IV) - Inattentive Subscale (Inatt). (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment) | The BAARS-IV is an 18-item, self-report questionnaire for which the participant respondent rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-5. Each item is scored on a 4-point scale ranging from 1 (never or rarely) to 4 (very often). The 18 items are grouped into 2 subscales. Each subscale produces a sub-scale score ranging from 0-36. A lower subscale score indicates less severe ADHD symptoms and behaviors. The calculation of the difference between Baseline and Midpoint (Mid-treatment) in the BAARS-IV Inatt score is Inatt at Day 25 minus Inatt at Day 0; and the difference between Baseline and Endpoint (Post-treatment) is Inatt at Day 50 minus Inatt at Day 0 A negative change indicates improvement on the subscale from Day 0 to Day 25 and Day 0 to Day 50. | Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50) |
| Los Angeles |
| California |
| 90095 |
| United States |