Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

Study Overview
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Brief Summary
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The purpose of the study is to determine how cognitive control training (CCT) changes behavior in youth with subclinical depressive symptoms. This research will show what types of behavior changes are important for CCT to help reduce depressive symptoms. In the future, we will use this information to try to improve how we prevent the development of depression, so that it can help more patients.

Detailed Description
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The primary study investigator acknowledges contributions from Kate Fitzgerald, Emily Bilek, Christopher Monk, and Adriene Beltz.

Official Title
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Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

Conditions
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Depression, Subclinical Depressive Symptoms

Intervention / Treatment
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* Device: Computerized cognitive training (CCT) using EndeavorRx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing to engage in a technology-based intervention (technology will be provided if not already accessible to participant). Self-reported depressive symptoms Participants will be required to maintain a stable dose of medications for 4 weeks prior to the first assessment Exclusion Criteria: Color blindness Unable to play the video game for any reason The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnosis of clinical depression, psychosis, or Autism Spectrum Disorder Enrolled in current psychotherapy Endorses any item on the Columbia Suicide Severity Rating Scale (C-SSRS) (has present suicidal ideation) Has had any changes to their medication in the 4-weeks prior to study enrollment

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized cognitive training (CCT) using EndeavorRx<br>Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory. | Device: Computerized cognitive training (CCT) using EndeavorRx<br>* The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management.  25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms as measured by Children's Depression Inventory (CDI) | Self-report, 28 item scale on depressive symptoms. Total scores on this measure range from 0 to 54. Higher scores indicate worse depressive symptoms. | Baseline, following intervention (approximately 5 weeks) | 
| Change in cognitive control capacity NIH toolbox cognition composite score |  | Baseline, following intervention (approximately 5 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms as measured by CDI | Self-report, 28 item scale on depressive symptoms. Total scores on this measure range from 0 to 54. Higher scores indicate worse depressive symptoms. | Up to 5 months | 
| Cognitive control capacity as measured by NIH toolbox (NIHTB) cognition composite score | The NIHTB (NIHTB) cognitive battery consists of 10 tasks and can be administered in 40 min. The scores can be evaluated separately, or they can be combined into composite scores: crystallized cognition composite (reflecting the ability to access information from long-term memory and general knowledge), fluid cognition composite (reflecting the processing ability to adapt to novel environment and solve problems), and overall cognitive function composite (a combination of both crystallized and fluid scores). | Up to 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Training Video Game