Training Resiliency in Youth (TRY) Study (TRY)

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 Overview

• Status: Completed
• Conditions: Depression; Anxiety; Attention Concentration Difficulty
• Intervention / Treatment: Other: EVO Cognitive Remediation Game

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive Function	Measuring Executive Function (e.g., attention, working memory) via parent-report of children's symptoms.	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 5 times across 5 months
Depression	depression symptoms measured with self- and parent- report	Measured 5 times across 5 months
Anxiety	Measuring self- and parent-reported symptoms of anxiety.	Measured 5 times across 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion Regulation	Measuring self-reported cognitive aspects of emotion regulation (e.g., rumination, positive reappraisal).	Measured 5 times across 5 months

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Patricia Arean, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Actual): June 4, 2018
• Study Completion (Actual): June 4, 2018

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Executive Function; Digital Health Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: STUDY00003107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No