Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT05697627
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2023-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hcbecker@umich.edu', 'phone': '(734) 764-2580', 'title': 'Hannah Becker', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a small-scale study, and there was no randomization or control intervention provided.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': '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.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 6, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Minor neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase of depressive symptoms >25% on CDI from T1 to T2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase of depression symptoms >25% on CDI from T1 to T3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': '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.'}], 'classes': [{'title': 'Baseline CDI scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.85', 'spread': '3.65', 'groupId': 'OG000'}]}]}, {'title': 'Approximately 5 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.84', 'spread': '4.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant dropped out of the study before the follow-up assessment.'}, {'type': 'PRIMARY', 'title': "Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': '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.'}], 'classes': [{'title': 'Baseline - Raw CDRS-R scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.00', 'spread': '5.69', 'groupId': 'OG000'}]}]}, {'title': 'Approximately 5 weeks - Raw CDRS-R scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.05', 'spread': '3.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant dropped out of the study before the 5-week assessment.'}, {'type': 'PRIMARY', 'title': 'Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': 'Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory.\n\nComputerized 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.\n\n\\~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks'}], 'classes': [{'title': 'Overall RT on Stroop Task pre-intervention', 'categories': [{'measurements': [{'value': '1019.44', 'spread': '131.07', 'groupId': 'OG000'}]}]}, {'title': 'Overall RT on Stroop Task post-intervention', 'categories': [{'measurements': [{'value': '1018.28', 'spread': '140.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': '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.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 person did not complete the baseline cognitive assessment and also withdrew prior to follow-up assessment.'}, {'type': 'PRIMARY', 'title': 'Change in Cognitive Control Capacity - Conflict RT Stroop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': 'Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory.\n\nComputerized 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.\n\n\\~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks'}], 'classes': [{'title': 'Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Stroop Task pre-intervention', 'categories': [{'measurements': [{'value': '65.95', 'spread': '58.60', 'groupId': 'OG000'}]}]}, {'title': 'Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Stroop Task post-intervention', 'categories': [{'measurements': [{'value': '62.32', 'spread': '96.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': '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.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 person did not complete the baseline cognitive assessment and also withdrew prior to follow-up assessment.'}, {'type': 'PRIMARY', 'title': 'Change in Cognitive Control Capacity - Overall RT Flanker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': 'Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory.\n\nComputerized 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.\n\n\\~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks'}], 'classes': [{'title': 'Overall RT on Flanker Task pre-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '785.93', 'spread': '266.25', 'groupId': 'OG000'}]}]}, {'title': 'Overall RT on Flanker Task post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '778.62', 'spread': '435.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': "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.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Change in Cognitive Control Capacity - Conflict RT Flanker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': 'Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory.\n\nComputerized 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.\n\n\\~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks'}], 'classes': [{'title': 'Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Flanker Task pre-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '151.31', 'spread': '188.11', 'groupId': 'OG000'}]}]}, {'title': 'Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Flanker Task post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '311.82', 'spread': '970.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': "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.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': "Children's Depression Inventory (CDI) at Third Timepoint", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.30', 'spread': '6.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 months', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': "Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.27', 'spread': '3.82', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 months', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Cognitive Control Capacity - Overall Reaction Time (RT) Stroop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '982.60', 'spread': '70.39', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 months', 'description': '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.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Cognitive Control Capacity - Conflict RT Stroop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.45', 'spread': '76.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 months', 'description': '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.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Cognitive Control Capacity - Overall RT Flanker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '597.31', 'spread': '93.90', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 months', 'description': "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.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Cognitive Control Capacity - Conflict RT Flanker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '122.58', 'spread': '39.81', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 months', 'description': "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.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Feasibility/Acceptability and Experimental Outcome', 'timeFrame': 'Up to 4 months', 'description': "Outcome measures that indicate how much the video game was played and acceptability of the game as indicated by self-report ratings. Includes:\n\ngameplay 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).", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '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).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Computerized Cognitive Training (CCT) Using EndeavorRx', 'description': '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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'spread': '1.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-08', 'size': 731738, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-09T11:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-14', 'studyFirstSubmitDate': '2023-01-07', 'resultsFirstSubmitDate': '2025-05-03', 'studyFirstSubmitQcDate': '2023-01-21', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-14', 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Feasibility/Acceptability and Experimental Outcome', 'timeFrame': 'Up to 4 months', 'description': "Outcome measures that indicate how much the video game was played and acceptability of the game as indicated by self-report ratings. Includes:\n\ngameplay 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)."}], 'primaryOutcomes': [{'measure': "Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)", 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': '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.'}, {'measure': "Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R)", 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': '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.'}, {'measure': 'Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop', 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': '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.'}, {'measure': 'Change in Cognitive Control Capacity - Conflict RT Stroop', 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': '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': 'Change in Cognitive Control Capacity - Overall RT Flanker', 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': "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."}, {'measure': 'Change in Cognitive Control Capacity - Conflict RT Flanker', 'timeFrame': 'Baseline and approximately 5 weeks after', 'description': "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."}], 'secondaryOutcomes': [{'measure': "Children's Depression Inventory (CDI) at Third Timepoint", 'timeFrame': 'Up to 4 months', 'description': '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': "Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint", 'timeFrame': 'Up to 4 months', 'description': '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.'}, {'measure': 'Cognitive Control Capacity - Overall Reaction Time (RT) Stroop', 'timeFrame': 'Up to 4 months', 'description': '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.'}, {'measure': 'Cognitive Control Capacity - Conflict RT Stroop', 'timeFrame': 'Up to 4 months', 'description': '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': 'Cognitive Control Capacity - Overall RT Flanker', 'timeFrame': 'Up to 4 months', 'description': "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."}, {'measure': 'Cognitive Control Capacity - Conflict RT Flanker', 'timeFrame': 'Up to 4 months', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cognitive Training Video Game'], 'conditions': ['Depression', 'Subclinical Depressive Symptoms']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The primary study investigator acknowledges contributions from Kate Fitzgerald, Emily Bilek, Christopher Monk, and Adriene Beltz.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study.\n2. Males and females (age 9 - 17.99)\n3. 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).\n4. Self-reported depressive symptoms (Children's Depression Inventory \\[CDI\\] score between 3-19 at Assessment 1)\n5. Participants will be required to maintain a stable dose of medications\n\nEXCLUSION CRITERIA\n\n1. Color blindness\n2. Unable to play the video game for any reason\n3. Current Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnosis of clinical depression, psychosis, or Autism Spectrum Disorder\n4. 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\n5. 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.\n6. Has had any changes to their medication in the 4-weeks prior to study enrollment"}, 'identificationModule': {'nctId': 'NCT05697627', 'briefTitle': 'Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth', 'orgStudyIdInfo': {'id': 'HUM00227345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Computerized cognitive training (CCT) using EndeavorRx', 'description': 'Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory.', 'interventionNames': ['Device: Computerized cognitive training (CCT) using EndeavorRx']}], 'interventions': [{'name': 'Computerized cognitive training (CCT) using EndeavorRx', 'type': 'DEVICE', 'description': 'The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management.\n\n\\~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks', 'armGroupLabels': ['Computerized cognitive training (CCT) using EndeavorRx']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Hannah Becker, M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'contact'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral Candidate in Clinical Science', 'investigatorFullName': 'Hannah Becker, MS', 'investigatorAffiliation': 'University of Michigan'}}}}