Attention Deficit Hyperactivity DisorderNCT06256003
Assessing Mobile Apps for Adult ADHD
A study testing UC-A and UC-N in people with Attention Deficit Hyperactivity Disorder, run by Think Now Incorporated at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- UC-A and UC-N
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jan 2024to 23 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The participant is aged 18-50 years at time of consent
- Fluent in English.
- Available for 2 contiguous months to participate in study, including 3 in-person visits to the university.
- Able to sit in a regular chair for 30 minutes in a small room for testing.
- Able to use a keyboard with both hands.
- Normal or corrected to normal vision and hearing.
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- Have a smart Phone.
- Estimated Intelligence Quotient (IQ) > 80 as assessed by the Wechsler Abbreviated Scale Intelligence (WASI-II) Matrix Reasoning and Vocabulary subtests.
- Meet established Diagnostic and Statistical Manual of Mental Health-Fifth Edition (DSM-5-TR) presentation for ADHD predominantly inattentive or combined subtype with clinically significant levels of impairment, diagnosed by semi-structured clinical interview and the Adult ADHD Clinical Diagnostic Scale (ACDS).
Who cannot join
- History of diagnosis of childhood neurodevelopmental disorder including autism spectrum disorder and dyslexia, other than ADHD or those specifically allowed in the Allowed Disorders section.
- Lifetime history of DSM5 bipolar disorder, psychotic disorder, panic disorder, agoraphobia, obsessive compulsive disorder as assessed with the MINI International Neuropsychiatric Interview (MINI).
- Current DSM5 diagnosis of posttraumatic stress disorder, or Major Depressive Disorder or Major Depressive Episode via self-report or as assessed with the MINI.
- Current Persistent Depressive Disorder (Dysthymia) or Anxiety Disorder if not on allowed medication that has been at a stable dose for at least 8 weeks (if on allowed medication with stable dose for 8 weeks, then allow).
- Substance or Alcohol Use Disorder rated as moderate or severe, with symptoms ≥ 4, as assessed by the MINI, or self-report of a Substance/Alcohol Use Disorder (allow endorsement of substance or alcohol use that does not meet moderate-severe use disorder criterion, if clean at visit).
- History of severe sleep disorder, narcolepsy, epilepsy/seizure disorder, brain tumor, stroke, TBI, severe concussion resulting in loss of consciousness and hospitalization, serious oxygen deprivation (such as following heart attack, carbon monoxide poisoning, near drowning or near suffocation), encephalitis, meningitis, or other major neurological disorder.
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- History of chronic fatigue syndrome, Long-COVID.
- Other medical or psychiatric conditions that are sufficient to likely compromise current attentional function and assessment in the opinion of the investigator.
- Current ongoing treatment, deemed by the participant and their PCP as indicated for continued use during the study, with psychotropics suspected to alter attentional functioning such as antipsychotic medications, sedative hypnotics, mood stabilizers, benzodiazepines, atypical antidepressants, or anticonvulsants (listed in the Excluded Medications List, or in the opinion of the investigator are likely to interfere with study cognitive assessments).
- Participant is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation or self-injurious behavior as measured by Columbia Suicide Severity Rating Scale at screening.
- Current treatment with guanfacine (due to the unacceptable risks of rapid withdrawal) and other medications for focus and attention problems such as Strattera, Modafinil, Armodafinil, and Clonidine that require long wash out periods (see Excluded ADHD Medications List).
- Participant plans to initiate during the primary study new concomitant prescription medications that are on the Excluded Medications List.
- Participant plans to initiate during the primary study behavioral therapy or training to improve cognition by means of game or app-based cognitive trainings or neurofeedback.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California Berkeley
Berkeley, California, 94720
UCLA Semel Institute
Los Angeles, California, 90095
About this study
Official title: A Randomized, Controlled, Parallel-Group, Intervention Study to Assess At-Home, Digital Therapy for Treating Adult Participants Ages 18-50 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
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.
Read the detailed description
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- UC-A, UC-N
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-ADevice
Mobile app digital therapy
UC-NDevice
Mobile app digital therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: UC-A |
| 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. Receives: Device: UC-N |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start3 Jan 2024
- Primary completion23 Nov 2024
- Study completion23 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Think Now Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, University of California, Berkeley
- Responsible party
- Sponsor
- Investigators
- Robert Bilder, Ph.D, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256003
- Sponsor's protocol ID
- SAC-II
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Parallel-Group, Intervention Study to Assess At-Home, Digital Therapy for Treating Adult Participants Ages 18-50 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT06256003
- Acronym / sponsor ID
- SAC-II
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Think Now IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, University of California, Berkeley
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 23 Nov 2024 (actual)
- Study completion
- 23 Nov 2024 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC-A | Active comparator | Device: UC-AUC-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. |
| UC-N | Active comparator | Device: UC-NUC-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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The participant is aged 18-50 years at time of consent
- Fluent in English.
- Available for 2 contiguous months to participate in study, including 3 in-person visits to the university.
- Able to sit in a regular chair for 30 minutes in a small room for testing.
- Able to use a keyboard with both hands.
Key exclusion criteria (13 listed)
- History of diagnosis of childhood neurodevelopmental disorder including autism spectrum disorder and dyslexia, other than ADHD or those specifically allowed in the Allowed Disorders section.
- Lifetime history of DSM5 bipolar disorder, psychotic disorder, panic disorder, agoraphobia, obsessive compulsive disorder as assessed with the MINI International Neuropsychiatric Interview (MINI).
- Current DSM5 diagnosis of posttraumatic stress disorder, or Major Depressive Disorder or Major Depressive Episode via self-report or as assessed with the MINI.
- Current Persistent Depressive Disorder (Dysthymia) or Anxiety Disorder if not on allowed medication that has been at a stable dose for at least 8 weeks (if on allowed medication with stable dose for 8 weeks, then allow).
- Substance or Alcohol Use Disorder rated as moderate or severe, with symptoms ≥ 4, as assessed by the MINI, or self-report of a Substance/Alcohol Use Disorder (allow endorsement of substance or alcohol use that does not meet moderate-severe use disorder criterion, if clean at visit).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UC-AMobile app digital therapy | Device | UC-A |
| UC-NMobile app digital therapy | Device | UC-N |
Primary outcome
Conners Continuous Performance Task (CPT3) - HRT Std (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)
Time frame: Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50)
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.
2 secondary outcomes
Nelson Denny Reading Comprehension Test (NDRT) - Reading Comprehension Scaled Score (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)
Time frame: 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)
Time frame: Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bilder, Ph.D principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UC-A and UC-N in people with Attention Deficit Hyperactivity Disorder, run by Think Now Incorporated at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conners Continuous Performance Task (CPT3) - HRT Std (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment) (time frame: Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.