Clinical trial NCT05472545: Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth
Official title: Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Regulation
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 210
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 in the experimental condition will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.

Detailed 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.

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
* 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

Primary outcomes:
measure: Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
timeFrame: One hour (measured during one scan session)
measure: Resting-state network activity
timeFrame: One year (change from first scan session to one-year follow-up)
Secondary outcomes:
measure: Depressive symptoms (change over time)
timeFrame: One year (change from first scan session to one-year follow-up)
measure: Parenting behaviors (change over time)
timeFrame: One year (change from first scan session to one-year follow-up)
measure: Emotion regulation (change over time)
timeFrame: One year (change from first scan session to one-year follow-up)
measure: Parent-adolescent interaction quality (change over time)
timeFrame: Two weeks
measure: Affect variability (change over time)
timeFrame: Two weeks
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Hardesty Center for Clinical Research and Neuroscience
state: Oklahoma
Study officials:
affiliation: Oklahoma State University
name: Kara L Kerr, PhD
role: PRINCIPAL_INVESTIGATOR
References: