Attention Deficit Hyperactivity DisorderSAC-INCT02489279

Training Attentional Awareness and Control in ADHD

A study testing Scrabble in people with Attention Deficit Hyperactivity Disorder, run by Think Now Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder
What is being tested?: Scrabble
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 1 siteUnited States
Study dates: Jun 2015to Apr 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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
Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
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)
Able in the opinion of the investigator to complete all required study procedures.

Who cannot join

History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
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
History of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
Serious oxygen deprivation
Current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
Current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity)
Current treatment with guanfacine.

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA Semel Institute
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Training Attentional Awareness and Control in Attention Deficit Hyperactivity Disorder (ADHD)

Read the 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.

Conditions: Attention Deficit Hyperactivity Disorder
Being tested: Sustained Attention Control (SAC) Method, Scrabble
Keywords: Attention deficit hyperactivity disorder., Attention training, Mobile devices, Brain training
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.

Sustained Attention Control (SAC) MethodBehavioural
Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.
ScrabbleBehavioural
Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.

Study groups in NCT02489279
Study group	Role	What they receive
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. Receives: Behavioral: Sustained Attention Control (SAC) Method
Control - Scrabble	Active comparator	Behavioral learning using the mobile software game "Scrabble" to exercise word processing and executive control functions. Receives: Behavioral: Scrabble

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline and 10 weeks

Secondary outcomes (2)

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.
Measured: 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.
Measured: Baseline and 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Apr 2017

First posted3 Jul 2015 (estimated)
Study startJun 2015
Primary completionDec 2016
Study completionApr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02489279
Sponsor's protocol ID: TNI-SAC-I
Other IDs: R43MH101924
Acronym: SAC-I
Status last verified: Jun 2019
First submitted: 30 Jun 2015
Last updated: 10 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)

All Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Training Attentional Awareness and Control in Attention Deficit Hyperactivity Disorder (ADHD)
ClinicalTrials.gov ID: NCT02489279
Acronym / sponsor ID: SAC-I / TNI-SAC-I
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention deficit hyperactivity disorder., Attention training, Mobile devices, Brain training
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Think Now IncorporatedIndustry (pharma, biotech, devices)
Collaborators: National Institute of Mental Health (NIMH)
Study start: Jun 2015
Primary completion: Dec 2016 (actual)
Study completion: Apr 2017 (actual)
First posted: 3 Jul 2015 (estimated)
Results: Posted 10 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active - SAC	Experimental	Behavioral: Sustained Attention Control (SAC) MethodBehavioral 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: ScrabbleBehavioral learning using the mobile software game "Scrabble" to exercise word processing and executive control functions.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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
Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
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)
Able in the opinion of the investigator to complete all required study procedures.

Key exclusion criteria (7 listed)

History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
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
History of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
Serious oxygen deprivation
Current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants

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
Sustained Attention Control (SAC) MethodParticipants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.	Behavioural	Active - SAC
ScrabbleParticipants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.	Behavioural	Control - Scrabble

Primary outcome

Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score
Time frame: 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
Time frame: 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.

2 secondary outcomes

Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Inattentive Subscale
Time frame: Baseline and 10 weeks
Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Hyperactive Subscale
Time frame: Baseline and 10 weeks

Results and safety

Results posted to the registry on 10 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active	44	32
Control	41	31

Primary outcome: Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score

Time frame: Baseline and 10 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Active - SAC n = 29	Control - Scrabble n = 30
Value	-6.65 (13.75)	1.84 (14.80)

Active - SAC vs Control - Scrabble: p = 0.026, GLM with repeated measures ANOVA
Active - SAC: p = 0.0075, t-test, 1 sided
Control - Scrabble: p = 0.25, t-test, 1 sided

Population analysed: Completer analysis of all subjects for whom Conners CPT RT Variability was measured at Baseline and after completing 10 weeks of treatment.

Primary outcome: Change From Baseline in Nelson-Denny Reading Test - Comprehension Score

Time frame: Baseline and 10 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Active - SAC n = 25	Control - Scrabble n = 23
Value	7.36 (10.26)	1.04 (6.09)

Active - SAC vs Control - Scrabble: p = 0.014, GLM with repeated measures ANOVA
Active - SAC: p = 0.0005, t-test, 1 sided
Control - Scrabble: p = 0.21, t-test, 1 sided

Population analysed: Completer analysis of all subjects for whom Nelson-Denny Reading Comprehension was measured at Baseline and after completing 10 weeks of treatment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 weeks from Baseline.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Control	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Attention Deficit Hyperactivity Disorder

RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)

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.

Mark S Cohen, Ph.D. principal investigator

University of California, Los Angeles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Scrabble in people with Attention Deficit Hyperactivity Disorder, run by Think Now Incorporated at 1 site 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 4 inclusion and 7 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score (time frame: Baseline and 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02489279.

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 10 Jul 2019.