Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
NCT05697627, Not applicable, Completed, University of Michigan; results first posted 2025-06-18
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth | ClinicalTrials.gov |
| NCT number | NCT05697627 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 31 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Michigan | ClinicalTrials.gov |
| Conditions | Depression, Subclinical Depressive Symptoms | ClinicalTrials.gov |
| Interventions | Computerized cognitive training (CCT) using EndeavorRx | ClinicalTrials.gov |
| First posted | 2023-01-26 | ClinicalTrials.gov |
| Last updated | 2025-06-18 | ClinicalTrials.gov |
| Results first posted | 2025-06-18 | ClinicalTrials.gov |
| Limitations and caveats | This was a small-scale study, and there was no randomization or control intervention provided. | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI) | Baseline and approximately 5 weeks after | The CDI was a self-report, 27 item scale used to measure depressive symptoms. Total scores on the CDI ranged from 0 (no depressive symptoms) to 54 (extremely severe depressive symptoms). Higher scores indicated worse depressive symptoms. CDI scores were collected from participants at three timepoints: 1) baseline, 2) approximately 5 weeks after baseline, and 3) up to 4 months after baseline. Results reflect CDI scores collected at the first and second timepoints. | ClinicalTrials.gov |
| Primary | Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) | Baseline and approximately 5 weeks after | The CDRS-R is a clinician-administered tool used to assess the severity of depression in children and adolescents based on a 17-item scale of depressive symptoms. Total raw scores on this scale range from 17-113, with 17 indicating no or minimal depressive symptoms and 113 indicating extremely severe symptoms of depression. CDRS-R scores were collected from participants at three timepoints: 1) baseline, 2) approximately 5 weeks after baseline, and 3) up to 4 months after baseline. Results reflect CDRS-R scores collected at the first and second timepoints. | ClinicalTrials.gov |
| Primary | Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop | Baseline and approximately 5 weeks after | The Stroop task assesses cognitive control and emotion regulation over emotional information processing by measuring how quickly individuals name the ink color of words that are emotionally-charged or neutral. For this measure, lower scores indicated better performance, i.e., better cognitive control and emotion regulation. Results reflect the average reaction time across all trials of the Stroop task that participants completed. | ClinicalTrials.gov |
| Primary | Change in Cognitive Control Capacity - Conflict RT Stroop | Baseline and approximately 5 weeks after | The Stroop task assesses cognitive control and emotion regulation over emotional information processing by measuring how quickly individuals name the ink color of words that are emotionally-charged or neutral. For this measure, lower scores indicated better performance, i.e., better cognitive control and emotion regulation. Results reflect the difference in the reaction time between incongruent trials and congruent trials on the Stroop task. | ClinicalTrials.gov |
| Primary | Change in Cognitive Control Capacity - Overall RT Flanker | Baseline and approximately 5 weeks after | The Flanker task is a psychological experiment that assesses a person's ability to focus on a target stimulus while ignoring distracting stimuli. For this measure, higher scores indicate better performance. Results reflect the average reaction time across all trials of the Flanker task that participants completed at this timepoint. | ClinicalTrials.gov |
| Primary | Change in Cognitive Control Capacity - Conflict RT Flanker | Baseline and approximately 5 weeks after | The Flanker task is a psychological experiment that assesses a person's ability to focus on a target stimulus while ignoring distracting stimuli. For this measure, higher scores indicate better performance. Results reflect the difference in the reaction time between incongruent trials and congruent trials of the Flanker task. | ClinicalTrials.gov |
| Secondary | Children's Depression Inventory (CDI) at Third Timepoint | Up to 4 months | The CDI was a self-report, 27 item scale used to measure depressive symptoms. Total scores on the CDI ranged from 0 (no depressive symptoms) to 54 (extremely severe depressive symptoms). Higher scores indicated worse depressive symptoms. CDI scores were collected from participants at three timepoints: 1) baseline, 2) approximately 5 weeks after baseline, and 3) up to 4 months after baseline. Results reflect CDI scores collected at the third timepoint. | ClinicalTrials.gov |
| Secondary | Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint | Up to 4 months | The CDRS-R is a clinician-administered tool used to assess the severity of depression in children and adolescents based on a 17-item scale of depressive symptoms. Total raw scores on this scale range from 17-113, with 17 indicating no or minimal depressive symptoms and 113 indicating extremely severe symptoms of depression. CDRS-R scores were collected from participants at three timepoints: 1) baseline, 2) approximately 5 weeks after baseline, and 3) up to 4 months after baseline. Results reflect CDRS-R scores collected at the third timepoint. | ClinicalTrials.gov |
| Secondary | Cognitive Control Capacity - Overall Reaction Time (RT) Stroop | Up to 4 months | The Stroop task assesses cognitive control and emotion regulation over emotional information processing by measuring how quickly individuals name the ink color of words that are emotionally-charged or neutral. For this measure, lower scores indicated better performance, i.e., better cognitive control and emotion regulation. Results reflect the average reaction time across all trials of the Stroop task that participants completed at this timepoint. | ClinicalTrials.gov |
| Secondary | Cognitive Control Capacity - Conflict RT Stroop | Up to 4 months | The Stroop task assesses cognitive control and emotion regulation over emotional information processing by measuring how quickly individuals name the ink color of words that are emotionally-charged or neutral. For this measure, lower scores indicated better performance, i.e., better cognitive control and emotion regulation. Results reflect the difference in the reaction time between incongruent trials and congruent trials on the Stroop task. | ClinicalTrials.gov |
| Secondary | Cognitive Control Capacity - Overall RT Flanker | Up to 4 months | The Flanker task is a psychological experiment that assesses a person's ability to focus on a target stimulus while ignoring distracting stimuli. For this measure, higher scores indicate better performance. Results reflect the average reaction time across all trials of the Flanker task that participants completed at this timepoint. | ClinicalTrials.gov |
| Secondary | Cognitive Control Capacity - Conflict RT Flanker | Up to 4 months | The Flanker task is a psychological experiment that assesses a person's ability to focus on a target stimulus while ignoring distracting stimuli. For this measure, higher scores indicate better performance. Results reflect the difference in the reaction time between incongruent trials and congruent trials on the Flanker task. | ClinicalTrials.gov |
| Other | Feasibility/Acceptability and Experimental Outcome | Up to 4 months | Outcome measures that indicate how much the video game was played and acceptability of the game as indicated by self-report ratings. Includes: gameplay metrics from the video game (total amount of missions completed across the 4-weeks of the intervention), Endeavor Satisfaction Survey Scores (Scale 1-5 (3 is neutral) on each item; parent and child report), and depressive symptoms at baseline (Children's Depression Inventory). | ClinicalTrials.gov |
Outcomes 13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI) | Baseline and approximately 5 weeks after | One participant dropped out of the study before the follow-up assessment. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) | Baseline and approximately 5 weeks after | One participant dropped out of the study before the 5-week assessment. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop | Baseline and approximately 5 weeks after | 1 person did not complete the baseline cognitive assessment and also withdrew prior to follow-up assessment. | milliseconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Cognitive Control Capacity - Conflict RT Stroop | Baseline and approximately 5 weeks after | 1 person did not complete the baseline cognitive assessment and also withdrew prior to follow-up assessment. | milliseconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Cognitive Control Capacity - Overall RT Flanker | Baseline and approximately 5 weeks after | Only 19 participants completed any of the cognitive tasks at baseline or follow up. From the 19, 2 participants at pre-intervention did not complete the Flanker task. From the 19, 1 participant at post-intervention did not complete the Flanker task. | milliseconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Cognitive Control Capacity - Conflict RT Flanker | Baseline and approximately 5 weeks after | Only 19 participants completed any of the cognitive tasks at baseline or follow up. From the 19, 2 participants at pre-intervention did not complete the Flanker task. From the 19, 1 participant at post-intervention did not complete the Flanker task. | milliseconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Children's Depression Inventory (CDI) at Third Timepoint | Up to 4 months | The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 10 participants returned and completed the CDI at the optional third time point. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint | Up to 4 months | The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 11 participants returned to complete the CDRS-R for the optional third timepoint. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Cognitive Control Capacity - Overall Reaction Time (RT) Stroop | Up to 4 months | The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 11 participants completed the third timepoint assessment, and 6 participants completed the cognitive tasks at this timepoint (including Stroop). | milliseconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Cognitive Control Capacity - Conflict RT Stroop | Up to 4 months | The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 11 participants completed the third timepoint assessment, and 6 participants completed the cognitive tasks at this timepoint (including Stroop). | milliseconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Cognitive Control Capacity - Overall RT Flanker | Up to 4 months | The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 11 participants completed the third timepoint assessment, and 6 participants completed the cognitive tasks at this timepoint (including Flanker). | milliseconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Cognitive Control Capacity - Conflict RT Flanker | Up to 4 months | The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 11 participants completed the third timepoint assessment, and 6 participants completed the cognitive tasks at this timepoint (including Flanker). | milliseconds | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Feasibility/Acceptability and Experimental Outcome | Up to 4 months | ClinicalTrials.gov |
Results by group 18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI) | Computerized Cognitive Training (CCT) Using EndeavorRx | Baseline CDI scores | 8.85 | Standard Deviation 3.65 | score on a scale | ClinicalTrials.gov |
| Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI) | Computerized Cognitive Training (CCT) Using EndeavorRx | Approximately 5 weeks | 5.84 | Standard Deviation 4.37 | score on a scale | ClinicalTrials.gov |
| Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) | Computerized Cognitive Training (CCT) Using EndeavorRx | Baseline - Raw CDRS-R scores | 30.00 | Standard Deviation 5.69 | score on a scale | ClinicalTrials.gov |
| Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) | Computerized Cognitive Training (CCT) Using EndeavorRx | Approximately 5 weeks - Raw CDRS-R scores | 24.05 | Standard Deviation 3.29 | score on a scale | ClinicalTrials.gov |
| Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop | Computerized Cognitive Training (CCT) Using EndeavorRx | Overall RT on Stroop Task pre-intervention | 1019.44 | Standard Deviation 131.07 | milliseconds | ClinicalTrials.gov |
| Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop | Computerized Cognitive Training (CCT) Using EndeavorRx | Overall RT on Stroop Task post-intervention | 1018.28 | Standard Deviation 140.31 | milliseconds | ClinicalTrials.gov |
| Change in Cognitive Control Capacity - Conflict RT Stroop | Computerized Cognitive Training (CCT) Using EndeavorRx | Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Stroop Task pre-intervention | 65.95 | Standard Deviation 58.60 | milliseconds | ClinicalTrials.gov |
| Change in Cognitive Control Capacity - Conflict RT Stroop | Computerized Cognitive Training (CCT) Using EndeavorRx | Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Stroop Task post-intervention | 62.32 | Standard Deviation 96.70 | milliseconds | ClinicalTrials.gov |
| Change in Cognitive Control Capacity - Overall RT Flanker | Computerized Cognitive Training (CCT) Using EndeavorRx | Overall RT on Flanker Task pre-intervention | 785.93 | Standard Deviation 266.25 | milliseconds | ClinicalTrials.gov |
| Change in Cognitive Control Capacity - Overall RT Flanker | Computerized Cognitive Training (CCT) Using EndeavorRx | Overall RT on Flanker Task post-intervention | 778.62 | Standard Deviation 435.33 | milliseconds | ClinicalTrials.gov |
| Change in Cognitive Control Capacity - Conflict RT Flanker | Computerized Cognitive Training (CCT) Using EndeavorRx | Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Flanker Task pre-intervention | 151.31 | Standard Deviation 188.11 | milliseconds | ClinicalTrials.gov |
| Change in Cognitive Control Capacity - Conflict RT Flanker | Computerized Cognitive Training (CCT) Using EndeavorRx | Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Flanker Task post-intervention | 311.82 | Standard Deviation 970.06 | milliseconds | ClinicalTrials.gov |
| Children's Depression Inventory (CDI) at Third Timepoint | Computerized Cognitive Training (CCT) Using EndeavorRx | 6.30 | Standard Deviation 6.48 | score on a scale | ClinicalTrials.gov | |
| Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint | Computerized Cognitive Training (CCT) Using EndeavorRx | 23.27 | Standard Deviation 3.82 | score on a scale | ClinicalTrials.gov | |
| Cognitive Control Capacity - Overall Reaction Time (RT) Stroop | Computerized Cognitive Training (CCT) Using EndeavorRx | 982.60 | Standard Deviation 70.39 | milliseconds | ClinicalTrials.gov | |
| Cognitive Control Capacity - Conflict RT Stroop | Computerized Cognitive Training (CCT) Using EndeavorRx | 58.45 | Standard Deviation 76.85 | milliseconds | ClinicalTrials.gov | |
| Cognitive Control Capacity - Overall RT Flanker | Computerized Cognitive Training (CCT) Using EndeavorRx | 597.31 | Standard Deviation 93.90 | milliseconds | ClinicalTrials.gov | |
| Cognitive Control Capacity - Conflict RT Flanker | Computerized Cognitive Training (CCT) Using EndeavorRx | 122.58 | Standard Deviation 39.81 | milliseconds | ClinicalTrials.gov |
Participant flow 3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Computerized Cognitive Training (CCT) Using EndeavorRx | 20 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Computerized Cognitive Training (CCT) Using EndeavorRx | 19 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Computerized Cognitive Training (CCT) Using EndeavorRx | 1 | ClinicalTrials.gov |
Adverse events 5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Minor neck pain | Musculoskeletal and connective tissue disorders | Computerized Cognitive Training (CCT) Using EndeavorRx | 1 | 20 | 1 | ClinicalTrials.gov |
| other | Common cold | Respiratory, thoracic and mediastinal disorders | Computerized Cognitive Training (CCT) Using EndeavorRx | 1 | 20 | 1 | ClinicalTrials.gov |
| other | Flu | Respiratory, thoracic and mediastinal disorders | Computerized Cognitive Training (CCT) Using EndeavorRx | 2 | 20 | 2 | ClinicalTrials.gov |
| other | Increase of depressive symptoms >25% on CDI from T1 to T2 | Psychiatric disorders | Computerized Cognitive Training (CCT) Using EndeavorRx | 1 | 20 | 1 | ClinicalTrials.gov |
| other | Increase of depression symptoms >25% on CDI from T1 to T3 | Psychiatric disorders | Computerized Cognitive Training (CCT) Using EndeavorRx | 2 | 20 | 2 | ClinicalTrials.gov |
Adverse event totals 3
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Computerized Cognitive Training (CCT) Using EndeavorRx | 0 | 20 | ClinicalTrials.gov |
| Total, other adverse events | Computerized Cognitive Training (CCT) Using EndeavorRx | 6 | 20 | ClinicalTrials.gov |
| Total, serious adverse events | Computerized Cognitive Training (CCT) Using EndeavorRx | 0 | 20 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Eriksen Flanker Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)