Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Resting-state network activity
研究概览
简要总结
This study will examine the effect of a real-time functional magnetic resonance imaging (fMRI) dyadic neurofeedback protocol with mothers and their adolescent daughters. Mothers in the experimental condition will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.
详细描述
Adolescents with a family history of adverse childhood experiences (ACEs) are at heightened risk for depression and other mental health problems related to poor emotion regulation (ER). The proposed study will test the efficacy of a real-time fMRI dyadic neurofeedback (DNF) protocol to promote healthy ER-related neurodevelopment in female adolescents with a maternal history of ACEs. The proposed study will use DNF to provide neurofeedback from the adolescent's anterior insular cortex (aIC) to the adolescent's mother as the mother and adolescent engage in an emotion discussion task together. Parents and adolescents (n=35 active DNF; n=35 control) will communicate via microphones and noise-canceling headphones while the adolescent is undergoing fMRI scanning. Specific aims of the current study are to determine: 1) the effects of aIC DNF on the developing ER network in adolescents with a history of maternal ACEs, 2) associations between parenting practices during DNF and reduced adolescent aIC activation, and 3) longitudinal effects of aIC DNF on adolescent internalizing symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Dyads will be randomly assigned to the experimental or control condition. This study cannot have true masking, as participants in the experimental group will know they are receiving neurofeedback. The control group will not be informed of the existence of the neurofeedback condition.
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All participants inclusion criteria:
- •Biological female
- •Sufficient English fluency to complete tasks
- •Co-residing at least 4 days per week
- •Inclusion criteria for adult participants:
- •Primary caregiver for more than 50% of child's lifespan
- •History of at least two adverse childhood experiences
- •Biological parent of adolescent participant
- •Inclusion criteria for adolescents:
- •Eligible for fMRI
- •Body mass index between 16 and 40 (inclusive)
- •Age 14-17 years
排除标准
- •Exclusion criteria for adolescent participants:
- •Current or past psychiatric disorder
- •Neurodevelopmental delay
- •Medications influencing fMRI
- •Medical conditions influencing fMRI
研究组 & 干预措施
Neurofeedback Group
Mothers of adolescent participants will view real-time fMRI neurofeedback representing activity in their daughter's anterior insula during an emotion discussion task. Activity will be presented as a colored bar of moving height, and mothers will be instructed to attempt to downregulate the activity through what they say to their daughter.
干预措施: Neurofeedback (Behavioral)
Control Group
The paradigm for the control condition will be identical to that of the experimental condition except that no neurofeedback will be presented. Participants in the control group will be told that we would like to see if the mother can regulate her daughter's brain activity through supportive statements.
结局指标
主要结局
Resting-state network activity
时间窗: One year (change from first scan session to one-year follow-up)
Brain activity during fMRI resting-state scan
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
时间窗: One hour (measured during one scan session)
Activation in the right anterior insular cortex and associated regions. We hypothesize that lower activity will indicate a better outcome.
次要结局
- Parent-adolescent interaction quality (change over time)(Two weeks)
- Emotion regulation (change over time)(One year (change from first scan session to one-year follow-up))
- Affect variability (change over time)(Two weeks)
- Depressive symptoms (change over time)(One year (change from first scan session to one-year follow-up))
- Parenting behaviors (change over time)(One year (change from first scan session to one-year follow-up))
研究者
Kara Kerr
Assistant Professor
Oklahoma State University