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Completed

NCT Number: NCT05472545

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.

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Key information

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hardesty Center for Clinical Research and Neuroscience

Tulsa, Oklahoma, 74136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurofeedback

Behavioral

Real-time functional magnetic resonance imaging dyadic neurofeedback

Primary outcomes

  1. Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)

    Time frame: 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.

  2. Resting-state network activity

    Time frame: One year (change from first scan session to one-year follow-up)

    Brain activity during fMRI resting-state scan

Secondary outcomes

  1. Depressive symptoms (change over time)

    Time frame: 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.

  2. Parenting behaviors (change over time)

    Time frame: 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.

  3. Emotion regulation (change over time)

    Time frame: 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.

  4. Parent-adolescent interaction quality (change over time)

    Time frame: Two weeks

    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.

  5. Affect variability (change over time)

    Time frame: Two weeks

    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.

Sponsors and collaborators

Lead sponsor

Oklahoma State University Center for Health Sciences

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2022
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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