Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

NCT05472545 | Active Not Recruiting

• 1 other identifier: 2022029-Hardesty
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Regulation

Outcome Measures

Primary Outcomes (2)

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

  Activation in the right anterior insular cortex and associated regions. We hypothesize that lower activity will indicate a better outcome.

  One hour (measured during one scan session)

• Resting-state network activity

  Brain activity during fMRI resting-state scan

  One year (change from first scan session to one-year follow-up)

Secondary Outcomes (5)

• 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)

• Emotion regulation (change over time)

  One year (change from first scan session to one-year follow-up)

• Parent-adolescent interaction quality (change over time)

  Two weeks

• Affect variability (change over time)

  Two weeks

Study Arms (2)

Neurofeedback Group

EXPERIMENTAL

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.

Behavioral: Neurofeedback

Control Group

NO INTERVENTION

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.

Interventions

Neurofeedback BEHAVIORAL

Real-time functional magnetic resonance imaging dyadic neurofeedback

Neurofeedback Group

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: Parent report of child's sex assigned at birth as "female" and current gender identity as "girl"
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Biological female
• Sufficient English fluency to complete tasks
• Co-residing at least 4 days per week
• Primary caregiver for more than 50% of child's lifespan
• History of at least two adverse childhood experiences
• Biological parent of adolescent participant
• Eligible for fMRI
• Body mass index between 16 and 40 (inclusive)
• Age 14-17 years

You may not qualify if:

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

Sponsors & Collaborators

• Oklahoma State University Center for Health Sciences: lead

Study Sites (1)

Hardesty Center for Clinical Research and Neuroscience

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

Emotional Regulation

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Kara L Kerr, PhD

  Oklahoma State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: March 13, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

US (1)