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Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity

Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04964726
Enrollment
30
Registered
2021-07-16
Start date
2021-05-11
Completion date
2022-12-07
Last updated
2023-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Life Stress, Emotional Dysfunction

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

Detailed description

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.

Interventions

BEHAVIORALReal-time fMRI dyadic neurofeedback

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

Sponsors

Oklahoma State University
CollaboratorOTHER
Oklahoma State University Center for Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes

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 * Right-handed * Body mass index between 16 and 40 (inclusive) * Age 14-17 years

Design outcomes

Primary

MeasureTime frameDescription
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)One hour (measured during first scan session)Activation in the brain region targeted for neurofeedback and associated regions at Session 1. We hypothesize that lower activity will indicate a better outcome.
Resting-state network activity (change over time)Change in resting-state activity over one week, from Session 1 to Session 2. Resting-state scan will last approximately 8 minutes.Brain activity during fMRI resting-state scan
Parent validating statements (change over time)Change in frequency in validation as coded by the manual over one week, from Session 1 to Session 2. Validating statements are measured and recorded during the scan sessions.Validating statements made by the parent participant during the scan sessions. Statements will be coded using the Parent-Child Validation/Invalidation Behavior Coding Scales (Schneider & Fruzzetti, 2002). Higher scores are indicative of a better outcome.

Secondary

MeasureTime frameDescription
Parenting behaviors (change over time)Measured at the first research session and biweekly for two monthsChange 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.
Emotion regulation (change over time)Measured at the first research session and biweekly for two monthsChange 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.
Depressive symptoms (change over time)Measured at the first research session and biweekly for two monthsChange 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026