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CompletedNCT03429465TRYUpdated Aug 8, 2018

Training Resiliency in Youth (TRY) Study

An interventional study of EVO Cognitive Remediation Game in Attention Concentration Difficulty, Depression and Anxiety, sponsored by University of Washington. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2018-08-08.

Sponsored by University of Washington · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Sex
All
01

Study 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 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.

02

Conditions studied

  • Attention Concentration Difficulty
  • Depression
  • Anxiety

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Keywords

  • Digital Health Intervention
  • Executive Function
  • Depression
  • Anxiety
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    EVO

    All children receive 4 weeks of EVO 5 days/week for 20 minutes per day in a stepped wedge design.

    Other: EVO Cognitive Remediation Game

Interventions

  • OtherEVO Cognitive Remediation Game

    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).

05

What researchers measure

Primary outcomes

  1. Executive Function

    Measuring Executive Function (e.g., attention, working memory) via parent-report of children's symptoms.

    Time frame: Measured 5 times across 5 months

  2. 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.

    Time frame: Measured 5 times across 5 months

  3. Depression

    depression symptoms measured with self- and parent- report

    Time frame: Measured 5 times across 5 months

  4. Anxiety

    Measuring self- and parent-reported symptoms of anxiety.

    Time frame: Measured 5 times across 5 months

Secondary outcomes

  1. Emotion Regulation

    Measuring self-reported cognitive aspects of emotion regulation (e.g., rumination, positive reappraisal).

    Time frame: Measured 5 times across 5 months

06

Study locations

1 site
  • University of Washington
    Seattle, Washington 98195, United States
07

Registry details

Key details

Study ID
NCT03429465
Lead sponsor
University of Washington
Responsible party
Pat Arean (Professor, School of Medicine: Psychiatry And Behavioral Sciences, University of Washington) — Principal investigator
First posted
Feb 12, 2018
Start date
Jan 16, 2018
Primary completion
Jun 4, 2018
Completion
Jun 4, 2018
Last update
Aug 8, 2018

Study contacts

Patricia Arean
principal investigator · University of Washington

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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