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 range9 Years – 17 Years

SexALL

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

✕. Color blindness
✕. Unable to play the video game for any reason
✕. 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

What they're measuring

Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)

Timeframe: Baseline and approximately 5 weeks after

Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R)

Timeframe: Baseline and approximately 5 weeks after

Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop

Timeframe: Baseline and approximately 5 weeks after

Change in Cognitive Control Capacity - Conflict RT Stroop

Timeframe: Baseline and approximately 5 weeks after

Change in Cognitive Control Capacity - Overall RT Flanker

Timeframe: Baseline and approximately 5 weeks after

Change in Cognitive Control Capacity - Conflict RT Flanker

Timeframe: Baseline and approximately 5 weeks after

Trial details

NCT IDNCT05697627

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01

Results submitted2025-05-03

View on ClinicalTrials.gov More Depression trials

Plain-language summary

Who can participate

Age range9 Years – 17 Years

SexALL

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

✕. Color blindness
✕. Unable to play the video game for any reason
✕. 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

What they're measuring

Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)

Timeframe: Baseline and approximately 5 weeks after

Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R)

Timeframe: Baseline and approximately 5 weeks after

Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop

Timeframe: Baseline and approximately 5 weeks after

Change in Cognitive Control Capacity - Conflict RT Stroop

Timeframe: Baseline and approximately 5 weeks after

Change in Cognitive Control Capacity - Overall RT Flanker

Timeframe: Baseline and approximately 5 weeks after

Change in Cognitive Control Capacity - Conflict RT Flanker

Timeframe: Baseline and approximately 5 weeks after