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Completed

NCT Number: NCT04964726

Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity

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.

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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

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.

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

Exclusion criteria

Exclusion criteria

for all participants:

  • Current psychiatric diagnosis

Exclusion criteria

for adolescent participants:

  • Neurodevelopmental delay
  • History of psychiatric disorder
  • Medications influencing fMRI
  • Medical conditions influencing fMRI

Treatment and study plan

Real-time fMRI dyadic neurofeedback

Behavioral

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: One hour (measured during second scan session)

    Activation in the brain region targeted for neurofeedback and associated regions at Session 2. We hypothesize that lower activity will indicate a better outcome.

  3. Resting-state network activity (change over time)

    Time frame: 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

  4. Parent validating statements (change over time)

    Time frame: 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 outcomes

  1. Parenting behaviors (change over time)

    Time frame: Measured at the first research session and biweekly for two months

    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.

  2. Emotion regulation (change over time)

    Time frame: Measured at the first research session and biweekly for two months

    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.

  3. Depressive symptoms (change over time)

    Time frame: Measured at the first research session and biweekly for two months

    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.

Sponsors and collaborators

Lead sponsor

Oklahoma State University Center for Health Sciences

Other

Collaborators

  • Oklahoma State University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2021
Registry last updated
Nov 15, 2023

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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