Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289010
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-24
Brief Title:
Neural Mechanisms of Family-Focused Treatment for Youth Depression
Sponsor:
Boston University Charles River Campus
Organization:
Boston University Charles River Campus
Study Overview
Official Title:
Neural Mechanisms of Evidence-Based Family-Focused Treatment for Youth Depression Preliminary Open Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this interventional study is to compare the baseline neural mechanisms and parenting in depressed and non-depressed children and to examine baseline neural mechanisms and parenting as predictors of Family-Focused Treatment for Childhood-Depression FFT-CD outcomes The main questions it aims to answer are
What are differences between depressed and non-depressed participants on baseline neural and parenting indicators
Do baseline neural and parenting indicators predict response to FFT-CD
Does change in parenting and neural functioning mediate change in depression from baseline to follow-up
Participants will
complete baseline clinical measures
complete neuroimaging tasks via Functional Magnetic Resonance Imaging fMR
undergo a 12-session course of FFT-CD
complete follow up evaluations and neuroimaging
What are differences between depressed and non-depressed participants on baseline neural and parenting indicators
Do baseline neural and parenting indicators predict response to FFT-CD
Does change in parenting and neural functioning mediate change in depression from baseline to follow-up
Participants will
complete baseline clinical measures
complete neuroimaging tasks via Functional Magnetic Resonance Imaging fMR
undergo a 12-session course of FFT-CD
complete follow up evaluations and neuroimaging
Detailed Description:
Childhood-onset depression is impairing often recurrent and persistent and negatively impacts development resulting in high personal social and economic costs Family-Focused Treatment for Childhood-Depression FFT-CD was developed to address the needs of depressed youth In a large randomized controlled trial FFT-CD was superior to individual therapy in promoting recovery from depression
Despite its promise there was high variability in degree of improvement in FFT-CD Our long-term goal is to integrate parenting neuroimaging and clinical measures to a reveal the parenting emotional and neural mechanisms of clinical benefit for FFT-CD and b examine what parent and child characteristics predict immediate and long-term benefit The proposed study will provide groundwork for this larger study by providing preliminary data
This study will enroll 40 children ages 7-12 - 20 with current depressive disorder and 20 with no history of mental health disorder -- and their parents 40 parents total At baseline parents and children will participate in a an evaluation of clinical state and family functioning b functional neuroimaging procedures to evaluate neural response to emotional cues faces potential reward and parent-child relations and resting state-connectivity and c structural imaging MRI and diffusion tensor imaging Participants with depressive disorders and their parents will then be provided a 12-session course of FFT-CD Brief clinical and parenting data will be collected at two points during treatment baseline procedures will be repeated at 4 months post-treatment The participants will engage in briefer clinical evaluation via telehealth 6 and 9 months post-treatment
Goals include 1 To examine differences between depressed and non-depressed participants in baseline neural and parenting 2 To examine baseline neural functioning emotional experience and parenting as predictors of FFT-CD outcome in our depressed group 3 To evaluate parenting and emotional experience across treatment and neural functioning measures at the end of treatment as mediators of change in depression from baseline to final follow-up
The neuroimaging hypotheses include
Naturalistic Videos Task Children with depression will display greater amygdala and insula activation to negatively vs neutrally valenced video clips There will be less striatal activation to positively vs neutrally valenced video clips in the depressed group compared to the n on-depressed group Dyads of depressed children and their parents will show less functional similarity while viewing naturalistic clips of parent-child interactions compared to healthy control dyads
Face Matching Task Depressed children will show amygdala and insula hyperactivation in response to negative faces and striatum hypoactivation in response to positive faces compared to healthy controls
Reward Processing Task Depressed children will show reduced striatal activation in response to reward anticipation and receipt relative to healthy controls
Evaluative Comments Task Depressed children will display higher activation in the default mode network during self-evaluation relative to non-depressed control children across both conditions We further expect a greater heightened Default Mode Network DMN response in the depressed group to negative words relative to positive words
Rest Dyads of depressed children and their parents will show less functional similarity in the resting state functional connectome relative to non-depressed control dyads Greater DMN connectivity will be observed at rest in depressed children relative to non-depressed control children
Magnetic Resonance Spectroscopy Depressed children will show elevated levels of glutamate aspartate choline and lactate and lower levels of ascorbate glutathione myo-inositol and N-acetyl aspartate relative to non-depressed controls consistent with neuroinflammation and excitotoxicityoxidative stress
Despite its promise there was high variability in degree of improvement in FFT-CD Our long-term goal is to integrate parenting neuroimaging and clinical measures to a reveal the parenting emotional and neural mechanisms of clinical benefit for FFT-CD and b examine what parent and child characteristics predict immediate and long-term benefit The proposed study will provide groundwork for this larger study by providing preliminary data
This study will enroll 40 children ages 7-12 - 20 with current depressive disorder and 20 with no history of mental health disorder -- and their parents 40 parents total At baseline parents and children will participate in a an evaluation of clinical state and family functioning b functional neuroimaging procedures to evaluate neural response to emotional cues faces potential reward and parent-child relations and resting state-connectivity and c structural imaging MRI and diffusion tensor imaging Participants with depressive disorders and their parents will then be provided a 12-session course of FFT-CD Brief clinical and parenting data will be collected at two points during treatment baseline procedures will be repeated at 4 months post-treatment The participants will engage in briefer clinical evaluation via telehealth 6 and 9 months post-treatment
Goals include 1 To examine differences between depressed and non-depressed participants in baseline neural and parenting 2 To examine baseline neural functioning emotional experience and parenting as predictors of FFT-CD outcome in our depressed group 3 To evaluate parenting and emotional experience across treatment and neural functioning measures at the end of treatment as mediators of change in depression from baseline to final follow-up
The neuroimaging hypotheses include
Naturalistic Videos Task Children with depression will display greater amygdala and insula activation to negatively vs neutrally valenced video clips There will be less striatal activation to positively vs neutrally valenced video clips in the depressed group compared to the n on-depressed group Dyads of depressed children and their parents will show less functional similarity while viewing naturalistic clips of parent-child interactions compared to healthy control dyads
Face Matching Task Depressed children will show amygdala and insula hyperactivation in response to negative faces and striatum hypoactivation in response to positive faces compared to healthy controls
Reward Processing Task Depressed children will show reduced striatal activation in response to reward anticipation and receipt relative to healthy controls
Evaluative Comments Task Depressed children will display higher activation in the default mode network during self-evaluation relative to non-depressed control children across both conditions We further expect a greater heightened Default Mode Network DMN response in the depressed group to negative words relative to positive words
Rest Dyads of depressed children and their parents will show less functional similarity in the resting state functional connectome relative to non-depressed control dyads Greater DMN connectivity will be observed at rest in depressed children relative to non-depressed control children
Magnetic Resonance Spectroscopy Depressed children will show elevated levels of glutamate aspartate choline and lactate and lower levels of ascorbate glutathione myo-inositol and N-acetyl aspartate relative to non-depressed controls consistent with neuroinflammation and excitotoxicityoxidative stress
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None