Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity

NCT ID: NCT04964726

Last Updated: 2023-11-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-11

Study Completion Date

2022-12-07

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 will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.

Detailed Description

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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.

Conditions

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Emotional Dysfunction Early Life Stress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Real-time fMRI dyadic neurofeedback

Group Type EXPERIMENTAL

Real-time fMRI dyadic neurofeedback

Intervention Type BEHAVIORAL

Participants will attempt to regulate their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.

Interventions

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Real-time fMRI dyadic neurofeedback

Participants will attempt to regulate their partner's brain activation in a specified brain region via real-time fMRI 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
* Right-handed
* Body mass index between 16 and 40 (inclusive)
* Age 14-17 years

Exclusion Criteria

* Current psychiatric diagnosis


* Neurodevelopmental delay
* History of psychiatric disorder
* Medications influencing fMRI
* Medical conditions influencing fMRI
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oklahoma State University

OTHER

Sponsor Role collaborator

Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hardesty Center for Clinical Research and Neuroscience

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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CHS2021035

Identifier Type: -

Identifier Source: org_study_id

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