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Clinical Trials/NCT04964726
NCT04964726
Completed
Not Applicable

Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity

Oklahoma State University Center for Health Sciences1 site in 1 country30 target enrollmentMay 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emotional Dysfunction
Sponsor
Oklahoma State University Center for Health Sciences
Enrollment
30
Locations
1
Primary Endpoint
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 11, 2021
End Date
December 7, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Oklahoma State University Center for Health Sciences
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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