NCT06289010 Neural Mechanisms of Family-Focused Treatment for Youth Depression
| NCT ID | NCT06289010 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston University Charles River Campus |
| Condition | Childhood Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-08-20 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-08-20 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Martha C Tompson, PhD
PRINCIPAL INVESTIGATOR
Boston University Charles River Campus
Frequently Asked Questions
Who can join the NCT06289010 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 12 Years, studying Childhood Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06289010 currently recruiting?
Yes, NCT06289010 is actively recruiting participants. Contact the research team at mtompson@bu.edu for enrollment information.
Where is the NCT06289010 trial being conducted?
This trial is being conducted at Boston, United States, Charlestown, United States.
Who is sponsoring the NCT06289010 clinical trial?
NCT06289010 is sponsored by Boston University Charles River Campus. The principal investigator is Martha C Tompson, PhD at Boston University Charles River Campus. The trial plans to enroll 80 participants.
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