Attention Concentration DifficultyTRYNCT03429465
Training Resiliency in Youth (TRY) Study
A study testing EVO Cognitive Remediation Game in people with Attention Concentration Difficulty and Depression, run by University of Washington at 1 site in United States.
Trial summary
The aim of the study is to determine whether a neuroscience-inspired cognitive remediation video game (EVO) that targets the cognitive control network (CCN) will improve executive functioning (EF) and resilience to psychiatric symptoms in typically developing 6th grade students, unselected for specific psychiatric… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Attention Concentration Difficulty, Depression, Anxiety
- What is being tested?
- EVO Cognitive Remediation Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2018to 4 Jun 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Currently enrolled in 6th grade during the 2017-2018 school year at Lucille Umbarger Elementary School in the Burlington-Edison School District
- Physical ability to use a touchscreen iPad
- Cognitive ability to assent, complete questionnaires, and play EVO game
- English speaking child, English or Spanish speaking parent
- Child has legal parent/guardian (i.e., not a ward of the state)
Who cannot join
- The child is identified by parent or school as diagnosed with an intellectual disability
- The child is identified by parent or school as diagnosed with a physical disability (i.e., unable to use hands or fingers) that would preclude use of a touchscreen iPad and appropriate engagement with EVO
- The child is identified by parent or school as unlikely to engage for 20 minutes with EVO
- Child unable to read or understand English
- Parent unable to read or understand English/Spanish
- Child is in public (i.e., child welfare) custody
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to determine whether a neuroscience-inspired cognitive remediation video game (EVO) that targets the cognitive control network (CCN) will improve executive functioning (EF) and resilience to psychiatric symptoms in typically developing 6th grade students, unselected for specific psychiatric symptoms. The primary goals are to 1) determine if EVO will result in improved EF and lower internalizing (e.g., mood, anxiety) and externalizing (e.g., attention deficit/hyperactivity disorder, AD/HD) psychiatric symptoms, 2) evaluate whether the benefit experienced by youth changes depending on their level of life stress (e.g., academic or social difficulties), 3) determine if EVO will promote resilience to stress. The investigators will measure EF, symptoms, and stress using self- and parent-report questionnaires. Other secondary outcomes include information on behavior in the classroom and academic performance (i.e., grades) that we will collect via school records. The investigators hypothesize that engagement with EVO 20-minutes per day, 5-days a week across 4-weeks will improve EF, lower psychiatric symptoms, improve academic/behavioral functioning at school, and decrease maladaptive responses to stress.
- Conditions
- Attention Concentration Difficulty, Depression, Anxiety
- Being tested
- EVO Cognitive Remediation Game
- Keywords
- Digital Health Intervention, Executive Function, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVO Cognitive Remediation GameOther
EVO (formerly called Neuroracer) is a neuroscience-inspired plasticity trainings in the form of a video driving game that uses adaptive algorithms and dual-tasking paradigms to target the CCN. Work from our group (Project:EVO) recently showed that 4 weeks of EVO training is associated with increased neural recruitment in brain regions associated with CNN, superior improvement in cognitive control performance (i.e., working memory, sustained attention) when compared to an evidence-based psychotherapy (Problem-Solving Therapy), and improved depression outcomes similar to Problem-Solving Therapy among older adults (Areán, Hallgren, Jordan, Gazzaley, Atkins, Heagerty, \& Anguera, 2016; Journal of Medical Internet Research).
| Study group | Role | What they receive |
|---|---|---|
| EVO | Experimental | All children receive 4 weeks of EVO 5 days/week for 20 minutes per day in a stepped wedge design. Receives: Other: EVO Cognitive Remediation Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function
Measuring Executive Function (e.g., attention, working memory) via parent-report of children's symptoms.
Measured: Measured 5 times across 5 months
Behavioral Problems
Measuring difficulties with attention (i.e., attention deficit/hyperactivity disorder), oppositionality, and conduct at home and school as measured by parent-report on children's behavior.
Measured: Measured 5 times across 5 months
Depression
depression symptoms measured with self- and parent- report
Measured: Measured 5 times across 5 months
Anxiety
Measuring self- and parent-reported symptoms of anxiety.
Measured: Measured 5 times across 5 months
Secondary outcomes (1)
Emotion Regulation
Measuring self-reported cognitive aspects of emotion regulation (e.g., rumination, positive reappraisal).
Measured: Measured 5 times across 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start16 Jan 2018
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Concentration DifficultyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pat Arean, University of Washington
- Investigators
- Patricia Arean, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429465
- Sponsor's protocol ID
- STUDY00003107
- Acronym
- TRY
- Status last verified
- Aug 2018
- First submitted
- 5 Feb 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Resiliency in Youth (TRY) Study
- ClinicalTrials.gov ID
- NCT03429465
- Acronym / sponsor ID
- TRY / STUDY00003107
- Conditions
- Attention Concentration Difficulty, Depression, Anxiety
- Keywords
- Digital Health Intervention, Executive Function, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 12 Feb 2018 (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 aim of the study is to determine whether a neuroscience-inspired cognitive remediation video game (EVO) that targets the cognitive control network (CCN) will improve executive functioning (EF) and resilience to psychiatric symptoms in typically developing 6th grade students, unselected for specific psychiatric symptoms. The primary goals are to 1) determine if EVO will result in improved EF and lower internalizing (e.g., mood, anxiety) and externalizing (e.g., attention deficit/hyperactivity disorder, AD/HD) psychiatric symptoms, 2) evaluate whether the benefit experienced by youth changes depending on their level of life stress (e.g., academic or social difficulties), 3) determine if EVO will promote resilience to stress. The investigators will measure EF, symptoms, and stress using self- and parent-report questionnaires. Other secondary outcomes include information on behavior in the classroom and academic performance (i.e., grades) that we will collect via school records. The investigators hypothesize that engagement with EVO 20-minutes per day, 5-days a week across 4-weeks will improve EF, lower psychiatric symptoms, improve academic/behavioral functioning at school, and decrease maladaptive responses to stress.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVO | Experimental | Other: EVO Cognitive Remediation GameAll children receive 4 weeks of EVO 5 days/week for 20 minutes per day in a stepped wedge design. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Currently enrolled in 6th grade during the 2017-2018 school year at Lucille Umbarger Elementary School in the Burlington-Edison School District
- Physical ability to use a touchscreen iPad
- Cognitive ability to assent, complete questionnaires, and play EVO game
- English speaking child, English or Spanish speaking parent
- Child has legal parent/guardian (i.e., not a ward of the state)
Key exclusion criteria (6 listed)
- The child is identified by parent or school as diagnosed with an intellectual disability
- The child is identified by parent or school as diagnosed with a physical disability (i.e., unable to use hands or fingers) that would preclude use of a touchscreen iPad and appropriate engagement with EVO
- The child is identified by parent or school as unlikely to engage for 20 minutes with EVO
- Child unable to read or understand English
- Parent unable to read or understand English/Spanish
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 |
|---|---|---|
| EVO Cognitive Remediation GameEVO (formerly called Neuroracer) is a neuroscience-inspired plasticity trainings in the form of a video driving game that uses adaptive algorithms and dual-tasking paradigms to target the CCN. Work from our group (Project:EVO) recently showed that 4 weeks of EVO training is associated with increased neural recruitment in brain regions associated with CNN, superior improvement in cognitive control performance (i.e., working memory, sustained attention) when compared to an evidence-based psychotherapy (Problem-Solving Therapy), and improved depression outcomes similar to Problem-Solving Therapy among older adults (Areán, Hallgren, Jordan, Gazzaley, Atkins, Heagerty, \& Anguera, 2016; Journal of Medical Internet Research). | Other | EVO |
Primary outcome
Executive Function
Time frame: Measured 5 times across 5 months
Measuring Executive Function (e.g., attention, working memory) via parent-report of children's symptoms.
Behavioral Problems
Time frame: Measured 5 times across 5 months
Measuring difficulties with attention (i.e., attention deficit/hyperactivity disorder), oppositionality, and conduct at home and school as measured by parent-report on children's behavior.
Depression
Time frame: Measured 5 times across 5 months
depression symptoms measured with self- and parent- report
Anxiety
Time frame: Measured 5 times across 5 months
Measuring self- and parent-reported symptoms of anxiety.
1 secondary outcome
Emotion Regulation
Time frame: Measured 5 times across 5 months
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 8 Aug 2018.
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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.
Patricia Arean principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVO Cognitive Remediation Game in people with Attention Concentration Difficulty and Depression, run by University of Washington 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 5 inclusion and 6 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 8 Aug 2018. 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?
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?
Executive Function (time frame: Measured 5 times across 5 months). The study lists 4 primary outcomes in all. 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 8 Aug 2018.