CompletedNot Applicable

Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity

United States30 participantsStarted 2021-05-11

Plain-language 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.

Who can participate

Age range

14 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)

Timeframe: One hour (measured during first scan session)

Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)

Timeframe: One hour (measured during second scan session)

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.

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.

Trial details

NCT IDNCT04964726

SponsorOklahoma State University Center for Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-07

View on ClinicalTrials.gov More Emotional Dysfunction trials

Who can participate

Age range

14 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)

Timeframe: One hour (measured during first scan session)

Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)

Timeframe: One hour (measured during second scan session)

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.

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.