Examining brain and parenting factors in youth depression treatment
Neural Mechanisms of Evidence-Based, Family-Focused Treatment for Youth Depression: Preliminary Open Trial
This study is trying to see how brain activity and parenting styles affect how well children aged 7-12 with depression respond to a specific treatment program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Boston University Charles River Campus Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06289010 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to compare the neural mechanisms and parenting behaviors in children with and without depression, focusing on how these factors predict outcomes in Family-Focused Treatment for Childhood-Depression (FFT-CD). Participants, aged 7-12, will undergo neuroimaging and clinical evaluations before and after a 12-session FFT-CD program. The study seeks to understand the relationship between parenting, neural functioning, and depression recovery, providing preliminary data for future research. By integrating clinical and neuroimaging measures, the study hopes to identify predictors of treatment success.
Who should consider this trial
Good fit: Ideal candidates are children aged 7-12 with a current diagnosis of major depressive disorder or those without any mental health diagnosis.
Not a fit: Patients with conditions such as autism spectrum disorder, psychosis, or those currently on psychotropic medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for childhood depression by identifying key predictors of recovery.
How similar studies have performed: Previous studies have shown promise in using family-focused approaches for treating childhood depression, indicating potential success for this novel integration of neuroimaging and parenting factors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Boston University — Boston, Massachusetts, United States (Recruiting)
- Athinoula A. Martinos Imaging Center at Massachusetts Institute of Technology — Charlestown, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Martha C Tompson, PhD
- Email: mtompson@bu.edu
- Phone: 617-353-9495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.