Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

Study Overview
=================
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.

Official Title
-----------------
Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

Conditions
-----------------
Emotional Regulation

Intervention / Treatment
-----------------
* Behavioral: Neurofeedback


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofeedback Group<br>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. | Behavioral: Neurofeedback<br>* Real-time functional magnetic resonance imaging dyadic neurofeedback<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Resting-state network activity | Brain activity during fMRI resting-state scan | One year (change from first scan session to one-year follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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 |