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Neural Mechanisms of Family-Focused Treatment for Youth Depression

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
7 Years to 12 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
  • "At baseline parents and children will participate in (a) an evaluation of clinical state and family functioning, (b) functional neuroimaging procedures to evaluate neural response to emotional cues (faces), potential reward, and parent-child relations, and resting state-connectivity, and (c) structural imaging (MRI and diffusion tensor imaging)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at brain activity and parenting in children ages 7–12 with depression and with no mental health diagnosis. It tests whether these factors can help predict how children respond to family-focused treatment for depression. Participants will have brain scans, complete assessments, attend 12 treatment sessions, and return for follow-up visits.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Children must be ages 7–12.
  • Children must have a current diagnosis of major depression, lasting depression, or another listed form of depression—or have no mental health diagnosis.
  • Children must live with a parent or guardian who is willing to take part.
  • Children must be able and willing to agree to take part.
  • The participating parent must be the child's birth parent or a grandparent acting as a parent, and have lived with the child for more than 75% of the child's life.
  • The participating parent must not be pregnant.
  • The parent must be able to read and understand consent forms and give permission for the child to join.
  • All participants must be able to use English well.

Who can't join

  • A child has a condition that would prevent participation, such as autism, psychosis (trouble knowing what is real), OCD (repeated unwanted thoughts or actions), intellectual disability, or current drug or alcohol misuse or dependence.
  • A child has severe behavior problems that threaten a stable home, such as problems involving juvenile justice or child protective services.
  • A participant has a condition that would interfere with taking part or currently takes medicine for a mental health condition.
  • The child or main caregiver does not speak English.
  • A parent or child cannot safely have an MRI brain scan because of metal in the body, braces, certain implanted devices, or fear of tight spaces.
  • The child takes an antidepressant medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

MA