Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06289010 |
| Other study ID # |
7354E |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2024 |
| Est. completion date |
November 2027 |
Study information
| Verified date |
March 2024 |
| Source |
Boston University Charles River Campus |
| Contact |
Martha C Tompson, PhD |
| Phone |
617-353-9495 |
| Email |
mtompson[@]bu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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 excitotoxicity/oxidative stress.
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