Neural Mechanisms of Family-Focused Treatment for Youth Depression
Recruiting · NCT06289010 · Interventional (participants receive a specific treatment) · Lead sponsor: Boston University Charles River Campus
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- Children must:
- Have a current DSM-5 diagnosis of MDD, Persistent DD, or DDNOS (based on K-SADS-PL) OR not meet criteria for any DSM-5 mental health diagnosis (based on K-SADS-PL)
- Be ages 7-12
- Be living with a parent(s) or guardian willing to participate
- Be able and willing to provide informed consent/assent
- Parent must:
- Not be currently pregnant
- Be able to read, understand consent forms, and provide consent on their child's behalf
- Be the biological parent (or grandparent in parental role) of the participating child \& have lived with the child for more than 75% of the child's life.
- All participants must:
- Not have a disturbance that would interfere with participation such as autism spectrum disorder, psychosis, current substance dependence, current use of psychotropic medication, OCD, or MRI contraindication such as metal inside the body or claustrophobia
- Be proficient in English
Exclusion criteria
- Thought or other disturbance in the child that would interfere with the ability to participate in treatment or assessments (e.g., psychotic disorder, autism spectrum disorder, OCD, active substance abuse/dependence, intellectual disability, as assessed on KSADS-PL)
- Severe conduct disorders in the child that threaten the home stability (e.g. juvenile justice or children's protective service involvement as assessed on KSADS-PL) due to the potential impact on retention
- Youth or primary caregivers do not speak English
- Either parent or child has contraindications for neuroimaging (e.g., claustrophobia, metal implants, braces, electronically, magnetically, or mechanically activated devices such as cochlear implants)
- The child is on an antidepressant medication, as it may complicate neuroimaging interpretation.
Where it is running
2 locations listed across 1 US state.
- Boston University - Boston, Massachusetts, United States
- Athinoula A. Martinos Imaging Center at Massachusetts Institute of Technology - Charlestown, Massachusetts, United States