Family-Focused Treatment for Childhood Depression

Recruiting at 1 trial location

Overseen By Martha C Tompson, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Must not be taking: Antidepressants, Psychotropic

Disqualifiers: Autism, Psychosis, Substance dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 12 weeks

80 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 5 6 7}

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. ^{1 3 4 8 9}

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

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.

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

Group I: Depressed Group Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Focused Treatment for Childhood Depression: Model and Case Illustrations. Tompson, MC., Langer, DA., Hughes, JL., et al.[2020]

In a study of 134 children with depression, family-focused treatment for childhood depression (FFT-CD) showed a quicker response in reducing depressive symptoms compared to individual supportive psychotherapy (IP) during the initial treatment phase.

By the end of the one-year follow-up, both treatments resulted in similar recovery rates (76% for FFT-CD and 77% for IP), but FFT-CD appeared to offer better protection against recurrence and suicide attempts, with fewer incidents reported in that group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of family-focused treatment for child depression compared to individual psychotherapy: one-year outcomes. Asarnow, JR., Tompson, MC., Klomhaus, AM., et al.[2021]

Family-focused therapy (FFT) combined with mood-stabilizing medications significantly improves recovery from mood episodes and reduces recurrences and symptom severity in adults and adolescents with bipolar disorder, based on findings from eight randomized controlled trials over 1-2 years.

FFT is particularly effective for patients with relatives who exhibit high levels of expressed emotion, and current research is exploring its use as an early intervention for youth at risk for bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Focused Therapy for Bipolar Disorder: Reflections on 30 Years of Research. Miklowitz, DJ., Chung, B.[2018]

Family-focused therapy (FFT) significantly improved family functioning over 24 months in high-risk youth for bipolar disorder compared to psychoeducation-only treatment, suggesting that family dynamics play a crucial role in managing mood symptoms.

Improvements in family functioning were found to partially mediate reductions in depressive symptoms, indicating that addressing family relationships can be an effective strategy in treating early signs of bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of family intervention on psychosocial functioning and mood symptoms of youth at high risk for bipolar disorder. Weintraub, MJ., Schneck, CD., Posta, F., et al.[2022]

Family-focused therapy for anxiety disorders (FFT-AD) is designed to enhance the effectiveness of cognitive-behavioral therapy (CBT) by addressing family dynamics that can negatively impact treatment outcomes.

The therapy targets issues such as hostility, excessive accommodation, and critical attitudes from family members, which can lead to higher dropout rates and poorer results in CBT for anxious patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive couple and family intervention for patients with anxiety disorders. Chambless, DL.[2018]

Family-based interpersonal psychotherapy (FB-IPT) was found to be significantly more effective than child-centered therapy (CCT) in treating depression in preadolescents, with a remission rate of 66% compared to 31% in the CCT group.

FB-IPT not only reduced depressive symptoms more effectively but also led to significant improvements in anxiety and interpersonal relationships, suggesting that addressing social dynamics may play a key role in its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based interpersonal psychotherapy for depressed preadolescents: examining efficacy and potential treatment mechanisms. Dietz, LJ., Weinberg, RJ., Brent, DA., et al.[2018]

Family-focused treatment for childhood depression (FFT-CD) was more effective than individual supportive psychotherapy (IP), with 77.7% of children in FFT-CD showing a significant clinical response compared to 59.9% in IP, based on a study of 134 children aged 7 to 14 over 4 months.

Families involved in FFT-CD reported greater satisfaction and felt more equipped to manage depression, highlighting the importance of family integration in treatment for childhood depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial Comparing Family-Focused Treatment and Individual Supportive Therapy for Depression in Childhood and Early Adolescence. Tompson, MC., Sugar, CA., Langer, DA., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Development and efficacy of a family-focused treatment for depression in childhood. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Family focused treatment for patients with bipolar disorder in Turkey: a case series. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Family-Focused Treatment for Childhood Depression: Model and Case Illustrations. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of family-focused treatment for child depression compared to individual psychotherapy: one-year outcomes. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Family-Focused Therapy for Bipolar Disorder: Reflections on 30 Years of Research. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of family intervention on psychosocial functioning and mood symptoms of youth at high risk for bipolar disorder. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Adjunctive couple and family intervention for patients with anxiety disorders. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Family-based interpersonal psychotherapy for depressed preadolescents: examining efficacy and potential treatment mechanisms. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial Comparing Family-Focused Treatment and Individual Supportive Therapy for Depression in Childhood and Early Adolescence. [2019]