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临床试验/NCT04964726
NCT04964726已完成不适用

Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity

Oklahoma State University Center for Health Sciences2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)

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 will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.

详细描述

The current study will determine the effects of a real-time functional magnetic resonance imaging dyadic neurofeedback (rtfMRI-DNF) protocol that will train mothers with a history of adverse childhood experiences (ACEs) to regulate adolescents' activation in the anterior insular cortex (aIC) - a key brain region for ER. The proposed study will test the efficacy of this protocol to promote healthy ER-related neurodevelopment in adolescents with a maternal history of adversity. The proposed study will use DNF to provide neurofeedback from the adolescent's aIC to the parent as the parent and adolescent engage in an emotion discussion task together. Parents and adolescents (n=10 dyads) will communicate via microphones and noise-canceling headphones while the adolescent is undergoing fMRI scanning. Specific aims of the current study are: (1) to determine the brain response to aIC DNF adolescents, and (2) to determine effects of DNF on parenting behaviors. This study is significant because engaging with parents in DNF can promote positive ER development in adolescents at risk due to the intergenerational effects of ACEs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

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
  • Right-handed
  • Body mass index between 16 and 40 (inclusive)
  • Age 14-17 years

排除标准

  • Exclusion criteria for all participants:
  • Current psychiatric diagnosis
  • Exclusion criteria for adolescent participants:
  • Neurodevelopmental delay
  • History of psychiatric disorder
  • Medications influencing fMRI
  • Medical conditions influencing fMRI

结局指标

主要结局

Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)

时间窗: One hour (measured during second scan session)

Activation in the brain region targeted for neurofeedback and associated regions at Session 2. We hypothesize that lower activity will indicate a better outcome.

Parent validating statements (change over time)

时间窗: Change in frequency in validation as coded by the manual over one week, from Session 1 to Session 2. Validating statements are measured and recorded during the scan sessions.

Validating statements made by the parent participant during the scan sessions. Statements will be coded using the Parent-Child Validation/Invalidation Behavior Coding Scales (Schneider \& Fruzzetti, 2002). Higher scores are indicative of a better outcome.

Resting-state network activity (change over time)

时间窗: Change in resting-state activity over one week, from Session 1 to Session 2. Resting-state scan will last approximately 8 minutes.

Brain activity during fMRI resting-state scan

次要结局

  • Parenting behaviors (change over time)(Measured at the first research session and biweekly for two months)
  • Depressive symptoms (change over time)(Measured at the first research session and biweekly for two months)
  • Emotion regulation (change over time)(Measured at the first research session and biweekly for two months)

研究者

发起方
Oklahoma State University Center for Health Sciences
申办方类型
Other
责任方
Sponsor

研究点 (2)

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