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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, this information will be used to try to improve prevention of the development of depression, so that it can help more patients.
The primary study investigator acknowledges contributions from Kate Fitzgerald, Emily Bilek, Christopher Monk, and Adriene Beltz.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized cognitive training (CCT) using EndeavorRx | Experimental | Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized cognitive training (CCT) using EndeavorRx | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI) | 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. | Baseline and approximately 5 weeks after |
| Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) | 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. | Baseline and approximately 5 weeks after |
| Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop | 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. | Baseline and approximately 5 weeks after |
| Change in Cognitive Control Capacity - Conflict RT Stroop | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Children's Depression Inventory (CDI) at Third Timepoint | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility/Acceptability and Experimental Outcome | 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). |
Inclusion criteria:
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Hannah Becker, M.S. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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31 participants signed consent forms. During the pre-assignment phase of the study, participants completed several diagnostic and clinical assessments to see if they met eligibility criteria. 11 of these 31 individuals were not assigned to the intervention because of the following: did not meet eligibility criteria (n=9); lost to follow-up during pre-assignment (n=1); the study concluded prior to the assignment phase for this individual (n=1).
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| ID | Title | Description |
|---|---|---|
| FG000 | Computerized Cognitive Training (CCT) Using EndeavorRx | The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately ~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Computerized Cognitive Training (CCT) Using EndeavorRx | The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants were instructed to engage in approximately 25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI) | 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. | One participant dropped out of the study before the follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and approximately 5 weeks after |
|
Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Computerized Cognitive Training (CCT) Using EndeavorRx | The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants were instructed to engage in approximately 25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
This was a small-scale study, and there was no randomization or control intervention provided.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hannah Becker | University of Michigan | (734) 764-2580 | hcbecker@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2024 | Dec 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Baseline and approximately 5 weeks after |
| Change in Cognitive Control Capacity - Overall RT Flanker | 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. | Baseline and approximately 5 weeks after |
| Change in Cognitive Control Capacity - Conflict RT Flanker | 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. | Baseline and approximately 5 weeks after |
| Up to 4 months |
| Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint | 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. | Up to 4 months |
| Cognitive Control Capacity - Overall Reaction Time (RT) Stroop | 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. | Up to 4 months |
| Cognitive Control Capacity - Conflict RT Stroop | 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. | Up to 4 months |
| Cognitive Control Capacity - Overall RT Flanker | 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. | Up to 4 months |
| Cognitive Control Capacity - Conflict RT Flanker | 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. | Up to 4 months |
| Up to 4 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) | 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. | One participant dropped out of the study before the 5-week assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and approximately 5 weeks after |
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| Primary | Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop | 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. | 1 person did not complete the baseline cognitive assessment and also withdrew prior to follow-up assessment. | Posted | Mean | Standard Deviation | milliseconds | Baseline and approximately 5 weeks after |
|
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| Primary | Change in Cognitive Control Capacity - Conflict RT Stroop | 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. | 1 person did not complete the baseline cognitive assessment and also withdrew prior to follow-up assessment. | Posted | Mean | Standard Deviation | milliseconds | Baseline and approximately 5 weeks after |
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| Primary | Change in Cognitive Control Capacity - Overall RT Flanker | 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. | 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. | Posted | Mean | Standard Deviation | milliseconds | Baseline and approximately 5 weeks after |
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| Primary | Change in Cognitive Control Capacity - Conflict RT Flanker | 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. | 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. | Posted | Mean | Standard Deviation | milliseconds | Baseline and approximately 5 weeks after |
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| Secondary | Children's Depression Inventory (CDI) at Third Timepoint | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 4 months |
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| Secondary | Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 4 months |
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| Secondary | Cognitive Control Capacity - Overall Reaction Time (RT) Stroop | 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. | 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). | Posted | Mean | Standard Deviation | milliseconds | Up to 4 months |
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| Secondary | Cognitive Control Capacity - Conflict RT Stroop | 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. | 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). | Posted | Mean | Standard Deviation | milliseconds | Up to 4 months |
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| Secondary | Cognitive Control Capacity - Overall RT Flanker | 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. | 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). | Posted | Mean | Standard Deviation | milliseconds | Up to 4 months |
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| Secondary | Cognitive Control Capacity - Conflict RT Flanker | 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. | 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). | Posted | Mean | Standard Deviation | milliseconds | Up to 4 months |
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| Other Pre-specified | Feasibility/Acceptability and Experimental Outcome | 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). | Not Posted | Up to 4 months | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 6 |
| 20 |
| Common cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Flu | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Increase of depressive symptoms >25% on CDI from T1 to T2 | Psychiatric disorders | Systematic Assessment |
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| Increase of depression symptoms >25% on CDI from T1 to T3 | Psychiatric disorders | Systematic Assessment |
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