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Training Resiliency in Youth (TRY) Study (TRY)

Primary Purpose

Attention Concentration Difficulty, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EVO Cognitive Remediation Game
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Attention Concentration Difficulty focused on measuring Digital Health Intervention, Executive Function, Depression, Anxiety

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EVO

Arm Description

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

Outcomes

Primary Outcome Measures

Executive Function
Measuring Executive Function (e.g., attention, working memory) via parent-report of children's symptoms.
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.
Depression
depression symptoms measured with self- and parent- report
Anxiety
Measuring self- and parent-reported symptoms of anxiety.

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2018
Last Updated
August 6, 2018
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03429465
Brief Title
Training Resiliency in Youth (TRY) Study
Acronym
TRY
Official Title
Training Resiliency in Youth (TRY) Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
June 4, 2018 (Actual)
Study Completion Date
June 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Concentration Difficulty, Depression, Anxiety
Keywords
Digital Health Intervention, Executive Function, Depression, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVO
Arm Type
Experimental
Arm Description
All children receive 4 weeks of EVO 5 days/week for 20 minutes per day in a stepped wedge design.
Intervention Type
Other
Intervention Name(s)
EVO Cognitive Remediation Game
Intervention Description
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 Outcome Measure Information:
Title
Executive Function
Description
Measuring Executive Function (e.g., attention, working memory) via parent-report of children's symptoms.
Time Frame
Measured 5 times across 5 months
Title
Behavioral Problems
Description
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
Title
Depression
Description
depression symptoms measured with self- and parent- report
Time Frame
Measured 5 times across 5 months
Title
Anxiety
Description
Measuring self- and parent-reported symptoms of anxiety.
Time Frame
Measured 5 times across 5 months
Secondary Outcome Measure Information:
Title
Emotion Regulation
Description
Measuring self-reported cognitive aspects of emotion regulation (e.g., rumination, positive reappraisal).
Time Frame
Measured 5 times across 5 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Arean
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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Training Resiliency in Youth (TRY) Study

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