Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity
Primary Purpose
Emotional Dysfunction, Early Life Stress
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real-time fMRI dyadic neurofeedback
Sponsored by
About this trial
This is an interventional other trial for Emotional Dysfunction
Eligibility Criteria
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
Sites / Locations
- Hardesty Center for Clinical Research and NeuroscienceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Real-time fMRI dyadic neurofeedback
Arm Description
Outcomes
Primary Outcome Measures
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
Activation in the brain region targeted for neurofeedback and associated regions at Session 1. We hypothesize that lower activity will indicate a better outcome.
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
Activation in the brain region targeted for neurofeedback and associated regions at Session 2. We hypothesize that lower activity will indicate a better outcome.
Resting-state network activity (change over time)
Brain activity during fMRI resting-state scan
Parent validating statements (change over time)
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
Parenting behaviors (change over time)
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)
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.
Depressive symptoms (change over time)
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.
Full Information
NCT ID
NCT04964726
First Posted
June 25, 2021
Last Updated
August 23, 2022
Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
Oklahoma State University
1. Study Identification
Unique Protocol Identification Number
NCT04964726
Brief Title
Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity
Official Title
Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
Oklahoma State University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Dysfunction, Early Life Stress
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real-time fMRI dyadic neurofeedback
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Real-time fMRI dyadic neurofeedback
Intervention Description
Participants will attempt to regulate their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.
Primary Outcome Measure Information:
Title
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
Description
Activation in the brain region targeted for neurofeedback and associated regions at Session 1. We hypothesize that lower activity will indicate a better outcome.
Time Frame
One hour (measured during first scan session)
Title
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
Description
Activation in the brain region targeted for neurofeedback and associated regions at Session 2. We hypothesize that lower activity will indicate a better outcome.
Time Frame
One hour (measured during second scan session)
Title
Resting-state network activity (change over time)
Description
Brain activity during fMRI resting-state scan
Time Frame
Change in resting-state activity over one week, from Session 1 to Session 2. Resting-state scan will last approximately 8 minutes.
Title
Parent validating statements (change over time)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Parenting behaviors (change over time)
Description
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.
Time Frame
Measured at the first research session and biweekly for two months
Title
Emotion regulation (change over time)
Description
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.
Time Frame
Measured at the first research session and biweekly for two months
Title
Depressive symptoms (change over time)
Description
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.
Time Frame
Measured at the first research session and biweekly for two months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Parent report of child's gender identity as "girl"
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kara L Kerr, PhD
Phone
918-594-8242
Email
kara.kerr@okstate.edu
Facility Information:
Facility Name
Hardesty Center for Clinical Research and Neuroscience
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara L Kerr, PhD
Phone
918-594-8242
Email
kara.kerr@okstate.edu
First Name & Middle Initial & Last Name & Degree
Kara L Kerr, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity
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