Training Resiliency in Youth (TRY) Study

Depression Clinical Trial

— TRY  

Official title:

Training Resiliency in Youth (TRY) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429465
• Other study ID #: STUDY00003107
• Status: Completed
• Phase: N/A
• Start date: January 16, 2018
• Est. completion date: June 4, 2018

Study information

• Verified date: August 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Attention Concentration Difficulty
• Depression

Intervention

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).

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive Function	Measuring Executive Function (e.g., attention, working memory) via parent-report of children's symptoms.	Measured 5 times across 5 months
Primary	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
Primary	Depression	depression symptoms measured with self- and parent- report	Measured 5 times across 5 months
Primary	Anxiety	Measuring self- and parent-reported symptoms of anxiety.	Measured 5 times across 5 months
Secondary	Emotion Regulation	Measuring self-reported cognitive aspects of emotion regulation (e.g., rumination, positive reappraisal).	Measured 5 times across 5 months