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Completed

NCT Number: NCT03429465

Training Resiliency in Youth (TRY) 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.

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Key information

Conditions

Attention Concentration Difficulty Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

EVO Cognitive Remediation Game

Other

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).

Primary outcomes

  1. 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.

  2. 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.

  3. Depression

    Time frame: Measured 5 times across 5 months

    depression symptoms measured with self- and parent- report

  4. Anxiety

    Time frame: Measured 5 times across 5 months

    Measuring self- and parent-reported symptoms of anxiety.

Secondary outcomes

  1. Emotion Regulation

    Time frame: Measured 5 times across 5 months

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Acronym: TRY

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 12, 2018
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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