Family-Focused Treatment for Childhood Depression
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston University Charles River Campus
Must not be taking: Antidepressants, Psychotropic
Disqualifiers: Autism, Psychosis, Substance dependence, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
13567How 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.
13489Eligibility 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
+6 more
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.
+2 more
Trial 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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Athinoula A. Martinos Imaging Center at Massachusetts Institute of TechnologyCharlestown, MA
Boston UniversityBoston, MA
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Who Is Running the Clinical Trial?
Boston University Charles River CampusLead Sponsor
Massachusetts Institute of TechnologyCollaborator
References
Development and efficacy of a family-focused treatment for depression in childhood. [2021]Depression in childhood frequently involves significant impairment, comorbidity, stress, and mental health problems within the family. Family-Focused Treatment for Childhood Depression (FFT-CD) is a 15-session developmentally-informed, evidence-based intervention targeting family interactions to enhance resiliency within the family system to improve and manage childhood depression.
Family focused treatment for patients with bipolar disorder in Turkey: a case series. [2009]Family-focused therapy (FFT) is a 9-month, 21-session structured psychoeducational treatment for bipolar disorder. Several US-based studies have documented its efficacy as adjunctive to medication for depression stabilization and relapse prevention. However, FFT has never been applied outside of the United States. The objective of this case series is to explore the applicability of FFT in a non-Western culture. Ten patients with bipolar disorder and their family members attended the 9-month FFT as adjunctive to pharmacotherapy in an outpatient specialty clinic in Izmir, Turkey. Patients improved in Global Assessment of Functioning Scores and Clinical Global Impression Scores from pre- to posttreatment. Case studies are given, which illustrate the differences between Western and non-Western families coping with bipolar disorder. FFT was easily applied to a Turkish sample with few changes in format or focus. Adaptations included substitution of oral for written therapeutic tasks or homework assignments. Randomized controlled trials are needed to test the clinical effectiveness of FFT and other psychosocial interventions in non-Western cultures.
Family-Focused Treatment for Childhood Depression: Model and Case Illustrations. [2020]Although the evidence base for treatment of depressive disorders in adolescents has strengthened in recent years, less is known about the treatment of depression in middle to late childhood. A family-based treatment may be optimal in addressing the interpersonal problems and symptoms frequently evident among depressed children during this developmental phase, particularly given data indicating that attributes of the family environment predict recovery versus continuing depression among depressed children. Family-Focused Treatment for Childhood Depression (FFT-CD) is designed as a 15-session family treatment with both the youth and parents targeting two putative mechanisms involved in recovery: (a) enhancing family support, specifically decreasing criticism and increasing supportive interactions; and (b) strengthening specific cognitive-behavioral skills within a family context that have been central to CBT for depression, specifically behavioral activation, communication, and problem solving. This article describes in detail the FFT-CD protocol and illustrates its implementation with three depressed children and their families. Common themes/challenges in treatment included family stressors, comorbidity, parental mental health challenges, and inclusion/integration of siblings into sessions. These three children experienced positive changes from pre- to posttreatment on assessor-rated depressive symptoms, parent- and child-rated depressive symptoms, and parent-rated internalizing and externalizing symptoms. These changes were maintained at follow-up evaluations 4 and 9 months following treatment completion.
Randomized controlled trial of family-focused treatment for child depression compared to individual psychotherapy: one-year outcomes. [2021]Childhood-onset depression is associated with increased risk of recurrent depression and high morbidity extending into adolescence and adulthood. This multisite randomized controlled trial evaluated two active psychosocial treatments for childhood depression: family-focused treatment for childhood depression (FFT-CD) and individual supportive psychotherapy (IP). Aims were to describe effects through 52 weeks postrandomization on measures of depression, functioning, nondepressive symptoms, and harm events.
Family-Focused Therapy for Bipolar Disorder: Reflections on 30 Years of Research. [2018]Family-focused therapy (FFT) is an evidence-based intervention for adults and children with bipolar disorder (BD) and their caregivers, usually given in conjunction with pharmacotherapy after an illness episode. The treatment consists of conjoint sessions of psychoeducation regarding bipolar illness, communication enhancement training, and problem-solving skills training. This paper summarizes over 30 years of research on FFT and family processes in BD. Across eight randomized controlled trials with adults and adolescents with BD, FFT and mood-stabilizing medications have been found to hasten recovery from mood episodes, reduce recurrences, and reduce levels of symptom severity compared to briefer forms of psychoeducation and medications over 1-2 years. Several studies indicate that the effects of FFT on symptom improvement are greater among patients with high-expressed emotion relatives. New research focuses on FFT as an early intervention for youth at risk for BD, neuroimaging as a means of evaluating treatment mechanisms, and progress in implementing FFT in community mental health settings.
Effects of family intervention on psychosocial functioning and mood symptoms of youth at high risk for bipolar disorder. [2022]Family-focused therapy (FFT) is associated with reduced rates of mood episodes among youth at high risk for bipolar disorder (BD). In a randomized trial of FFT compared to a psychoeducation-only treatment (enhanced care, EC), we sought to determine if changes in psychosocial functioning mediate mood improvements among high-risk youth.
Adjunctive couple and family intervention for patients with anxiety disorders. [2018]Family-focused therapy for anxiety disorders (FFT-AD), a flexible couple/family treatment provided in conjunction with cognitive-behavioral therapy (CBT) for anxiety disorders, is described. The treatment is based upon research showing that anxious patients are more likely to drop out of or fare poorly in CBT when they live with a family member who is hostile toward or emotionally over-involved with the patient, accommodates excessively to the patient's anxiety, or is perceived by the patient to be destructively critical. An adaptation of FFT for bipolar disorder, the treatment is intended for patients with anxiety disorders, regardless of their specific disorder type. FFT-AD is illustrated with two cases.
Family-based interpersonal psychotherapy for depressed preadolescents: examining efficacy and potential treatment mechanisms. [2018]To conduct a randomized controlled trial to evaluate the preliminary efficacy of family-based interpersonal psychotherapy (FB-IPT) for treating depression in preadolescents (aged 7-12 years) as compared to child-centered therapy (CCT), a supportive and nondirective treatment that closely approximates the standard of care for pediatric depression in community mental health.
A Randomized Clinical Trial Comparing Family-Focused Treatment and Individual Supportive Therapy for Depression in Childhood and Early Adolescence. [2019]Despite the morbidity and negative outcomes associated with early-onset depression, few studies have examined the efficacy of psychosocial treatment for depressive disorders during childhood. Integrating family in treatment could have particularly salutary effects during this developmental period. This trial compared immediate posttreatment effects of family-focused treatment for childhood depression (FFT-CD) with those of individual supportive psychotherapy (IP) for children 7 to 14 years old with depressive disorders.