Recruiting

Neural Mechanisms of Family-Focused Treatment for Youth Depression

ClinicalTrials.gov IDNCT06289010

PhaseNA

Enrollment80

SponsorBoston University Charles River Campus

Age7 Years

SexALL

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Conditions studied

Childhood Depression

About this study

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

Interventions

Behavioral: Family-Focused Treatment for Childhood-Depression (FFT-CD) — This intervention includes 12 one-hour, in-person sessions. FFT-CD was designed to help families gain skills to combat depression and create ways of interacting that protect the child from the negative sequelae of stress. Within a broad psychoeducational framework, interpersonal factors impacting youth depression and the interplay of mood and interpersonal interactions are emphasized. Participants are taught to identify Upward Spirals - positive interactions fueling positive moods leading further upward - and Downward Spirals - negative interactions fueling negative moods leading further downward. The treatment rationale is "to stop downward spirals and to start upward spirals"; this idea provides a foundation for skills building to help the child and family better navigate stress. Handouts, role-playing, behavioral rehearsal, and homework assignments are all used to help shape behaviors.

Primary outcomes

Depression Treatment Response (4 months (post-treatment))
Children's Self Report of Depressive Symptoms (4 months)

Eligibility information

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.

Study locations

Boston University, Boston, Massachusetts 02215 United States
Athinoula A. Martinos Imaging Center at Massachusetts Institute of Technology, Charlestown, Massachusetts 02129 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.