Neural Mechanisms of Family-Focused Treatment for Youth Depression

NCT06289010 | Recruiting

• 1 other identifier: 7354E
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Conditions

Childhood Depression

Keywords

Neural Mechanisms; Depression; Children; Adolescent; Family

Outcome Measures

Primary Outcomes (2)

• Depression Treatment Response

  \>/= 50% reduction on Children's Depression Rating Scale-Revised (CDRS-R). Scores on this measure range from 17 to 113, and higher scores indicate greater depression severity.

  4 months (post-treatment)

• Children's Self Report of Depressive Symptoms

  Children's Depression Inventory (CDI) is a 28-item self-report measure. Scores range from 0 to 54 with higher scores reflecting higher levels of symptoms.

  4 months

Secondary Outcomes (1)

• Depression Remission

  4 months

Study Arms (1)

Depressed Group

EXPERIMENTAL

20 children with depression and their parents (40 participants total) will undergo a 12-session course of FFT-CD.

Behavioral: Family-Focused Treatment for Childhood-Depression (FFT-CD)

Interventions

Family-Focused Treatment for Childhood-Depression (FFT-CD) BEHAVIORAL

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.

Depressed Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Massachusetts Institute of Technology: collaborator

Study Sites (2)

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

Athinoula A. Martinos Imaging Center at Massachusetts Institute of Technology

Charlestown, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Martha C Tompson, PhD

CONTACT

617-353-9495; mtompson@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 1, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)