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Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05472545
Enrollment
180
Registered
2022-07-25
Start date
2023-03-13
Completion date
2025-10-13
Last updated
2026-06-10

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

Conditions

Emotional Regulation

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.

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.

Interventions

BEHAVIORALNeurofeedback

Real-time functional magnetic resonance imaging dyadic neurofeedback

Sponsors

Oklahoma State University Center for Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

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.

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 * 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 one scan session)Activation in the right anterior insular cortex and associated regions. We hypothesize that lower activity will indicate a better outcome.
Resting-state network activityOne year (change from first scan session to one-year follow-up)Brain activity during fMRI resting-state scan

Secondary

MeasureTime frameDescription
Depressive symptoms (change over time)One year (change from first scan session to one-year follow-up)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.
Parenting behaviors (change over time)One year (change from first scan session to one-year follow-up)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.
Emotion regulation (change over time)One year (change from first scan session to one-year follow-up)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.
Parent-adolescent interaction quality (change over time)Two weeksAdolescents 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.
Affect variability (change over time)Two weeksAdolescents 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKara L Kerr, PhD

Oklahoma State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026