Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)
研究概览
简要总结
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.
详细描述
The primary study investigator acknowledges contributions from Kate Fitzgerald, Emily Bilek, Christopher Monk, and Adriene Beltz.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Computerized cognitive training (CCT) using EndeavorRx
Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory.
干预措施: Computerized cognitive training (CCT) using EndeavorRx (Device)
结局指标
主要结局
Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)
时间窗: 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.
Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R)
时间窗: 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.
Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop
时间窗: 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.
Change in Cognitive Control Capacity - Conflict RT Stroop
时间窗: 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.
Change in Cognitive Control Capacity - Overall RT Flanker
时间窗: 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.
Change in Cognitive Control Capacity - Conflict RT Flanker
时间窗: 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.
次要结局
- Children's Depression Inventory (CDI) at Third Timepoint(Up to 4 months)
- Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint(Up to 4 months)
- Cognitive Control Capacity - Overall Reaction Time (RT) Stroop(Up to 4 months)
- Cognitive Control Capacity - Conflict RT Stroop(Up to 4 months)
- Cognitive Control Capacity - Overall RT Flanker(Up to 4 months)
- Cognitive Control Capacity - Conflict RT Flanker(Up to 4 months)
研究者
Hannah Becker, MS
Doctoral Candidate in Clinical Science
University of Michigan