Training Resiliency in Youth (TRY) Study

NCT03429465 | Completed

• 1 other identifier: STUDY00003107
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Concentration Difficulty; Depression; Anxiety

Keywords

Digital Health Intervention; Executive Function; Depression; Anxiety

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Emotion Regulation

  Measured 5 times across 5 months

Study Arms (1)

EVO

EXPERIMENTAL

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

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).

EVO

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Patricia Arean

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Psychiatry And Behavioral Sciences

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: January 16, 2018
• Primary Completion: June 4, 2018
• Study Completion: June 4, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

US (1)