Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity

Sponsor
Oklahoma State University Center for Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04964726
Collaborator
Oklahoma State University (Other)
26
1
1
18.7
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Real-time fMRI dyadic neurofeedback
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity
Actual Study Start Date :
May 11, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Real-time fMRI dyadic neurofeedback

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

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

  1. Parenting behaviors (change over time) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hardesty Center for Clinical Research and Neuroscience Tulsa Oklahoma United States 74136

Sponsors and Collaborators

  • Oklahoma State University Center for Health Sciences
  • Oklahoma State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT04964726
Other Study ID Numbers:
  • CHS2021035
First Posted:
Jul 16, 2021
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022