Recruiting

Family-Focused Treatment

Sponsor:

Boston University Charles River Campus

Code:

NCT06289010

Conditions

Childhood Depression

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Accepted

Interventions

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

Study Details

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

Study ID

NCT06289010

Start date

Aug 20, 2024

Status verified date

Jul, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Depressed Group

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

Interventions

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 outcome measure

  • Depression Treatment Response [ Time Frame: 4 months (post-treatment) ]
  • Children's Self Report of Depressive Symptoms [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Martha C Tompson, PhD

617-353-9495mtompson@bu.edu

Locations

Boston University

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Martha C Tompson, PhD

617-358-4584mtompson@bu.edu

Natalie Marr, BS

6173539610nmarr@bu.edu

Principal Investigator:

Martha C Tompson, PhD

Athinoula A. Martinos Imaging Center at Massachusetts Institute of Technology

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

John DE Gabrieli, PhD

617-253-8946gabrieli@mit.edu

Principal Investigator:

John DE Gabrieli, PhD

More Information

Sponsor

Boston University Charles River Campus

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Neural Mechanisms
  • Depression
  • Children
  • Adolescent
  • Family

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University Charles River Campus on 2026-07-20.