Health TrialsbyHealthPanel

Neural Mechanisms of Family-Focused Treatment for Youth Depression

ConditionChildhood Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorBoston University Charles River Campus

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Depressed GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 months (post-treatment)
2

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.

Time frame
4 months

Secondary outcomes

1

Depression Remission

\</= 28 score on Children's Depression Rating Scale-Revised (CDRS-R)

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston University Charles River Campus

Lead sponsor

Massachusetts Institute of Technology

Collaborator

Source ClinicalTrials.gov
Apply now