Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Emotional Regulation
• Intervention / Treatment: Behavioral: Neurofeedback

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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Hardesty Center for Clinical Research and Neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

Exclusion criteria for adolescent participants:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Neurofeedback; Real-time functional magnetic resonance imaging dyadic neurofeedback
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms (change over time)	Change over time in adolescent's responses to the PROMIS (Patient Reported Outcome Measurement Information System) Pediatric Short Form Version 2 (Quinn et al., 2014). This is an 8-item scale with scores ranging from 8-40, with higher scores indicating more depressive symptoms.	One year (change from first scan session to one-year follow-up)
Parenting behaviors (change over time)	Change over time in adolescent's responses to the Children's Report of Parent Behavior Inventory (Schludermann & Schludermann, 1988). The CRPBI has 3 subscales, each with a score range of 10-30. Interpretation/valence of the scores varies by subscale.	One year (change from first scan session to one-year follow-up)
Emotion regulation (change over time)	Change over time in adolescent's responses to the Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2008). The DERS consists of 36 items rated on a 1-5 Likert scale (scale range: 36-180). Higher scores indicate greater difficulties with emotion regulation.	One year (change from first scan session to one-year follow-up)
Parent-adolescent interaction quality (change over time)	Adolescents will complete ecological momentary assessment (EMA) measures multiple times per day over a period of two weeks and report on emotions experienced during interactions with their mother. The ratio of positive to negative interactions across the EMA period will be calculated.	Two weeks
Affect variability (change over time)	Adolescents will complete ecological momentary assessment (EMA) measures multiple times per day over a period of two weeks and rate their current emotions at the time of the prompt. Affect variability will be quantified as the standard deviation in mean negative emotion ratings.	Two weeks

Collaborators and Investigators

• Sponsor: Oklahoma State University Center for Health Sciences
• Investigators: Principal Investigator: Kara L Kerr, PhD, Oklahoma State University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2022029-Hardesty

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No