RECRUITING

Neural Mechanisms of Family-Focused Treatment for Youth Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Neural Mechanisms of Evidence-Based, Family-Focused Treatment for Youth Depression: Preliminary Open Trial

Quick Facts

Study Start:2024-08-20
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06289010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children must:
  2. * 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)
  3. * Be ages 7-12
  4. * Be living with a parent(s) or guardian willing to participate
  5. * Be able and willing to provide informed consent/assent
  6. * Not be currently pregnant
  7. * Be able to read, understand consent forms, and provide consent on their child's behalf
  8. * 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.
  9. * 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
  10. * Be proficient in English
  1. * 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)
  2. * 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
  3. * Youth or primary caregivers do not speak English
  4. * Either parent or child has contraindications for neuroimaging (e.g., claustrophobia, metal implants, braces, electronically, magnetically, or mechanically activated devices such as cochlear implants)
  5. * The child is on an antidepressant medication, as it may complicate neuroimaging interpretation.

Contacts and Locations

Study Contact

Martha C Tompson, PhD
CONTACT
617-353-9495
mtompson@bu.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Boston University Charles River Campus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-20
Study Completion Date2027-11

Study Record Updates

Study Start Date2024-08-20
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • Neural Mechanisms
  • Depression
  • Children
  • Adolescent
  • Family

Additional Relevant MeSH Terms

  • Childhood Depression