Clinical trial NCT04964726: 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
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Dysfunction
Early Life Stress
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
Collaborators: name: Oklahoma State University
First posted: 2021-07-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
timeFrame: One hour (measured during first scan session)
measure: Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
timeFrame: One hour (measured during second scan session)
measure: Resting-state network activity (change over time)
timeFrame: Change in resting-state activity over one week, from Session 1 to Session 2. Resting-state scan will last approximately 8 minutes.
measure: Parent validating statements (change over time)
timeFrame: 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 outcomes:
measure: Parenting behaviors (change over time)
timeFrame: Measured at the first research session and biweekly for two months
measure: Emotion regulation (change over time)
timeFrame: Measured at the first research session and biweekly for two months
measure: Depressive symptoms (change over time)
timeFrame: Measured at the first research session and biweekly for two months
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Hardesty Center for Clinical Research and Neuroscience
state: Oklahoma
Study officials:
References: