Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

Oklahoma State University Center for Health Sciences

Status: Active, not recruiting

Conditions: Emotional Regulation

Treatments: Behavioral: Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05472545

2022029-Hardesty

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: Female

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

210 participants in 2 patient groups

Neurofeedback Group

Experimental group

Description:

Mothers of adolescent participants will view real-time fMRI neurofeedback representing activity in their daughter's anterior insula during an emotion discussion task. Activity will be presented as a colored bar of moving height, and mothers will be instructed to attempt to downregulate the activity through what they say to their daughter.

Treatment:

Behavioral: Neurofeedback

Control Group

No Intervention group

Description:

The paradigm for the control condition will be identical to that of the experimental condition except that no neurofeedback will be presented. Participants in the control group will be told that we would like to see if the mother can regulate her daughter's brain activity through supportive statements.