Emotional DysfunctionNCT04964726
Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity
A study testing Real-time fMRI dyadic neurofeedback in people with Emotional Dysfunction and Early Life Stress, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emotional Dysfunction, Early Life Stress
- What is being tested?
- Real-time fMRI dyadic neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2021to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All participants inclusion criteria:
- Biological female
- Sufficient English fluency to complete tasks
- Co-residing at least 4 days per week
- Primary caregiver for more than 50% of child's lifespan
- History of at least two adverse childhood experiences
Show all 11Show fewer
- Biological parent of adolescent participant
- Eligible for fMRI
- Right-handed
- Body mass index between 16 and 40 (inclusive)
- Age 14-17 years
Who cannot join
- Current psychiatric diagnosis
- Neurodevelopmental delay
- History of psychiatric disorder
- Medications influencing fMRI
- Medical conditions influencing fMRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Hardesty Center for Clinical Research and Neuroscience
Tulsa, Oklahoma, 74136
About this study
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.
Read the 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.
- Conditions
- Emotional Dysfunction, Early Life Stress
- Being tested
- Real-time fMRI dyadic neurofeedback
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time fMRI dyadic neurofeedbackBehavioural
Participants will attempt to regulate their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.
| Study group | Role | What they receive |
|---|---|---|
| Real-time fMRI dyadic neurofeedback | Experimental | Not described Receives: Behavioral: Real-time fMRI dyadic neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
Activation in the brain region targeted for neurofeedback and associated regions at Session 1. We hypothesize that lower activity will indicate a better outcome.
Measured: One hour (measured during first scan session)
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
Activation in the brain region targeted for neurofeedback and associated regions at Session 2. We hypothesize that lower activity will indicate a better outcome.
Measured: One hour (measured during second scan session)
Resting-state network activity (change over time)
Brain activity during fMRI resting-state scan
Measured: 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)
Validating statements made by the parent participant during the scan sessions. Statements will be coded using the Parent-Child Validation/Invalidation Behavior Coding Scales (Schneider \& Fruzzetti, 2002). Higher scores are indicative of a better outcome.
Measured: 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 (3)
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.
Measured: Measured at the first research session and biweekly for two months
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.
Measured: Measured at the first research session and biweekly for two months
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.
Measured: Measured at the first research session and biweekly for two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start11 May 2021
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964726
- Sponsor's protocol ID
- CHS2021035
- Status last verified
- Nov 2023
- First submitted
- 25 Jun 2021
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity
- ClinicalTrials.gov ID
- NCT04964726
- Acronym / sponsor ID
- CHS2021035
- Conditions
- Emotional Dysfunction, Early Life Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Collaborators
- Oklahoma State University
- Study start
- 11 May 2021 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real-time fMRI dyadic neurofeedback | Experimental | Behavioral: Real-time fMRI dyadic neurofeedback |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Biological female
- Sufficient English fluency to complete tasks
- Co-residing at least 4 days per week
- Primary caregiver for more than 50% of child's lifespan
- History of at least two adverse childhood experiences
Key exclusion criteria (5 listed)
- Current psychiatric diagnosis
- Neurodevelopmental delay
- History of psychiatric disorder
- Medications influencing fMRI
- Medical conditions influencing fMRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time fMRI dyadic neurofeedbackParticipants will attempt to regulate their partner's brain activation in a specified brain region via real-time fMRI neurofeedback. | Behavioural | Real-time fMRI dyadic neurofeedback |
Primary outcome
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
Time frame: One hour (measured during first scan session)
Activation in the brain region targeted for neurofeedback and associated regions at Session 1. We hypothesize that lower activity will indicate a better outcome.
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)
Time frame: One hour (measured during second scan session)
Activation in the brain region targeted for neurofeedback and associated regions at Session 2. We hypothesize that lower activity will indicate a better outcome.
Resting-state network activity (change over time)
Time frame: Change in resting-state activity over one week, from Session 1 to Session 2. Resting-state scan will last approximately 8 minutes.
Brain activity during fMRI resting-state scan
Parent validating statements (change over time)
Time frame: 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.
Validating statements made by the parent participant during the scan sessions. Statements will be coded using the Parent-Child Validation/Invalidation Behavior Coding Scales (Schneider \& Fruzzetti, 2002). Higher scores are indicative of a better outcome.
3 secondary outcomes
Parenting behaviors (change over time)
Time frame: Measured at the first research session and biweekly for two months
Emotion regulation (change over time)
Time frame: Measured at the first research session and biweekly for two months
Depressive symptoms (change over time)
Time frame: Measured at the first research session and biweekly for two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: Yes
Related trials for Emotional Dysfunction
Active, not recruiting
Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
Social Isolation in Older Adults, Poverty
RecruitingObservational study
Understanding Lifespan Trajectories of Social Cognition, Brain Microstructure and Iron Dysregulation in Schizophrenia
Healthy Control Subjects, Schizophrenia Diagnosis
Not yet recruiting
Jigsawdio Multisensory Platform for People With Mild Cognitive Impairment, Alzheimer's Disease, or Related Dementias
Alzheimer Disease, Dementia
Enrolling by invitationObservational study
NeuroFinance Human Stress Trial During Financial and Informational Volatility
Psychological Stress, Anxiety
Not yet recruitingObservational study
Inflammatory and Genetic Predictors of Cognitive and Emotional Recovery After Critical Illness
Post-Intensive Care Syndrome (PICS), Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time fMRI dyadic neurofeedback in people with Emotional Dysfunction and Early Life Stress, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation) (time frame: One hour (measured during first scan session)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.