Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Emotional Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type BEHAVIORAL

Real-time functional magnetic resonance imaging dyadic neurofeedback

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neurofeedback

Real-time functional magnetic resonance imaging dyadic neurofeedback

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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