80 Participants Needed

Family-Focused Treatment for Childhood Depression

Recruiting at 1 trial location
MC
Overseen ByMartha C Tompson, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Boston University Charles River Campus
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of 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

Will I have to stop taking my current medications?

If your child is currently taking an antidepressant, they will need to stop, as the trial does not allow children on antidepressant medication.

What data supports the effectiveness of the treatment Family-Focused Treatment for Childhood Depression (FFT-CD)?

Research shows that Family-Focused Treatment for Childhood Depression (FFT-CD) can lead to positive changes in depressive symptoms and family interactions, with improvements maintained months after treatment. Similar family-focused therapies have been effective in treating bipolar disorder, suggesting that involving family in therapy can enhance recovery and reduce symptoms.12345

Is Family-Focused Treatment for Childhood Depression safe for children?

Family-Focused Treatment for Childhood Depression (FFT-CD) has been used safely in children, showing positive changes in depressive symptoms and family interactions without reported safety concerns. Similar family-focused therapies have been used safely for other conditions like bipolar disorder and anxiety, suggesting a general safety in humans.13567

How is Family-Focused Treatment for Childhood Depression (FFT-CD) different from other treatments for childhood depression?

Family-Focused Treatment for Childhood Depression (FFT-CD) is unique because it involves the whole family in the treatment process, focusing on improving family interactions and support to help manage childhood depression. It combines family support with cognitive-behavioral techniques like communication and problem-solving, which are not typically emphasized in individual therapies.13489

Eligibility Criteria

This trial is for children with depression. Participants will undergo an MRI, attend a 12-session course of Family-Focused Treatment (FFT-CD), and complete follow-up evaluations. Specific eligibility criteria are not provided.

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)
Parent must not be currently pregnant
Parent must be able to read, understand consent forms, and provide consent on their child's behalf
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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
My child is currently taking antidepressant medication.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline clinical measures and neuroimaging tasks via fMRI

1-2 weeks
1 visit (in-person)

Treatment

Participants undergo a 12-session course of Family-Focused Treatment for Childhood-Depression (FFT-CD)

12 weeks
12 visits (in-person)

Post-Treatment Assessment

Baseline procedures are repeated to evaluate treatment outcomes

1-2 weeks
1 visit (in-person)

Follow-up

Participants complete follow-up evaluations and neuroimaging to assess long-term outcomes

6 months
2 visits (virtual)

Treatment Details

Interventions

  • Family-Focused Treatment for Childhood-Depression (FFT-CD)
Trial Overview The study tests how brain function and parenting behaviors affect the success of FFT-CD in treating childhood depression. It compares depressed children to non-depressed ones before and after treatment using MRI scans and clinical measures.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Depressed GroupExperimental Treatment1 Intervention
20 children with depression and their parents (40 participants total) will undergo a 12-session course of FFT-CD.

Family-Focused Treatment for Childhood-Depression (FFT-CD) is already approved in United States for the following indications:

🇺🇸
Approved in United States as Family-Focused Treatment for Childhood Depression for:
  • Childhood depression
  • Youth depression

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials
125
Recruited
14,100+

Massachusetts Institute of Technology

Collaborator

Trials
104
Recruited
12,810,000+

Findings from Research

Family-Focused Treatment for Childhood Depression (FFT-CD) was found to be more effective than individual supportive psychotherapy, with 77.7% of children in FFT-CD showing significant improvement in depression symptoms compared to 59.9% in the other group during treatment.
Both treatment groups had similar recovery rates from depressive episodes (around 76-77%), but FFT-CD showed a lower rate of depressive recurrences and suicide attempts at the 9-month follow-up, highlighting the potential long-term benefits of family interventions in managing childhood depression.
Development and efficacy of a family-focused treatment for depression in childhood.Tompson, MC., Langer, DA., Asarnow, JR.[2021]
Family-focused therapy (FFT) was successfully implemented in a Turkish outpatient clinic for 10 patients with bipolar disorder, showing improvements in their functioning and clinical impressions over a 9-month treatment period.
The study suggests that FFT can be adapted for non-Western cultures with minimal changes, indicating its potential for broader application, although further randomized controlled trials are necessary to confirm its effectiveness in these settings.
Family focused treatment for patients with bipolar disorder in Turkey: a case series.Ozerdem, A., Oguz, M., Miklowitz, D., et al.[2009]
Family-Focused Treatment for Childhood Depression (FFT-CD) is a 15-session program that effectively addresses depression in children by enhancing family support and teaching cognitive-behavioral skills, showing positive outcomes in three case studies.
The treatment led to significant reductions in depressive symptoms for the children involved, with improvements maintained for up to 9 months after completing the program, highlighting its potential long-term efficacy.
Family-Focused Treatment for Childhood Depression: Model and Case Illustrations.Tompson, MC., Langer, DA., Hughes, JL., et al.[2020]

References

Development and efficacy of a family-focused treatment for depression in childhood. [2021]
Family focused treatment for patients with bipolar disorder in Turkey: a case series. [2009]
Family-Focused Treatment for Childhood Depression: Model and Case Illustrations. [2020]
Randomized controlled trial of family-focused treatment for child depression compared to individual psychotherapy: one-year outcomes. [2021]
Family-Focused Therapy for Bipolar Disorder: Reflections on 30 Years of Research. [2018]
Effects of family intervention on psychosocial functioning and mood symptoms of youth at high risk for bipolar disorder. [2022]
Adjunctive couple and family intervention for patients with anxiety disorders. [2018]
Family-based interpersonal psychotherapy for depressed preadolescents: examining efficacy and potential treatment mechanisms. [2018]
A Randomized Clinical Trial Comparing Family-Focused Treatment and Individual Supportive Therapy for Depression in Childhood and Early Adolescence. [2019]
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