Clinical trial NCT03429465: Training Resiliency in Youth (TRY) Study
Official title: Training Resiliency in Youth (TRY) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Concentration Difficulty
Depression
Anxiety
Keywords: Digital Health Intervention
Executive Function
Depression
Anxiety
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Executive Function
timeFrame: Measured 5 times across 5 months
measure: Behavioral Problems
timeFrame: Measured 5 times across 5 months
measure: Depression
timeFrame: Measured 5 times across 5 months
measure: Anxiety
timeFrame: Measured 5 times across 5 months
Secondary outcomes:
measure: Emotion Regulation
timeFrame: Measured 5 times across 5 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Patricia Arean
role: PRINCIPAL_INVESTIGATOR
References: