Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

Emotional Regulation Clinical Trial

Official title:

Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472545
• Other study ID #: 2022029-Hardesty
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2023
• Source: Oklahoma State University Center for Health Sciences
• Contact: Kara L Kerr, PhD
• Phone: 918-594-8242
• Email: kara.kerr[@]okstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emotional Regulation

Intervention

Behavioral:
• Neurofeedback
Real-time functional magnetic resonance imaging dyadic neurofeedback

Locations

Country	Name	City	State
United States	Hardesty Center for Clinical Research and Neuroscience	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)	Activation in the right anterior insular cortex and associated regions. We hypothesize that lower activity will indicate a better outcome.	One hour (measured during one scan session)
Primary	Resting-state network activity	Brain activity during fMRI resting-state scan	One year (change from first scan session to one-year follow-up)
Secondary	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.	One year (change from first scan session to one-year follow-up)
Secondary	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.	One year (change from first scan session to one-year follow-up)
Secondary	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.	One year (change from first scan session to one-year follow-up)
Secondary	Parent-adolescent interaction quality (change over time)	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.	Two weeks
Secondary	Affect variability (change over time)	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.	Two weeks