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Clinical Trials/NCT05472545
NCT05472545
Active, not recruiting
Not Applicable

Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

Oklahoma State University Center for Health Sciences1 site in 1 country210 target enrollmentMarch 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emotional Regulation
Sponsor
Oklahoma State University Center for Health Sciences
Enrollment
210
Locations
1
Primary Endpoint
Resting-state network activity
Status
Active, not recruiting
Last Updated
9 months 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 in the experimental condition will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 13, 2023
End Date
September 1, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Oklahoma State University Center for Health Sciences
Responsible Party
Principal Investigator
Principal Investigator

Kara Kerr

Assistant Professor

Oklahoma State University

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 adolescent participants:
  • Current or past psychiatric disorder
  • Neurodevelopmental delay
  • Medications influencing fMRI
  • Medical conditions influencing fMRI

Outcomes

Primary Outcomes

Resting-state network activity

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • 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))
  • Parent-adolescent interaction quality (change over time)(Two weeks)

Study Sites (1)

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