Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth (NCT05697627) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
United States31 participantsStarted 2023-05-03
Plain-language summary
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, this information will be used to try to improve prevention of the development of depression, so that it can help more patients.
Who can participate
Age range
9 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study.
. Males and females (age 9 - 17.99)
. Participant is willing to engage in a technology-based intervention (technology will be provided to participants who live in the state of Michigan, if not already accessible to participant).
. Self-reported depressive symptoms (Children's Depression Inventory \[CDI\] score between 3-19 at Assessment 1)
. Participants will be required to maintain a stable dose of medications
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)
Timeframe: Baseline and approximately 5 weeks after
2
Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R)
Timeframe: Baseline and approximately 5 weeks after
3
Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop
Timeframe: Baseline and approximately 5 weeks after
4
Change in Cognitive Control Capacity - Conflict RT Stroop
Timeframe: Baseline and approximately 5 weeks after
5
Change in Cognitive Control Capacity - Overall RT Flanker
Timeframe: Baseline and approximately 5 weeks after
6
Change in Cognitive Control Capacity - Conflict RT Flanker
Timeframe: Baseline and approximately 5 weeks after
. Current Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnosis of clinical depression, psychosis, or Autism Spectrum Disorder
. Has enrolled in new psychotherapy (for the treatment of a mood or anxiety disorder) or had changes to their psychotherapy in the 4-weeks prior to study enrollment
. Endorses items #1, #2, #3, #4, #5, or #6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screener (Past-Month); i.e., has present suicidal intention/behavior.
. Has had any changes to their medication in the 4-weeks prior to study enrollment