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Clinical Trials/NCT01159041
NCT01159041
Completed
N/A

Evaluation of Family Focused Treatment for Childhood Depression

Boston University Charles River Campus2 sites in 1 country134 target enrollmentJanuary 2010
ConditionsDepression

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
Boston University Charles River Campus
Enrollment
134
Locations
2
Primary Endpoint
Adequate Depression Treatment Response
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study is designed to compare two treatments for depression in pre-adolescent (7-13 year old) children. A family-focused treatment will be compared to an individual child-focused treatment in this 14-week intervention.

Detailed Description

Childhood-onset depression is an impairing and often recurrent and persistent disorder that impacts current and later development resulting in high personal, social, and economic costs. Despite the costs of early-onset depression, the emphasis in current practice parameters on an initial course of psychosocial treatment, and extensive research on adolescent depression, we currently lack randomized controlled trials evaluating psychosocial treatments for children with depressive disorders. The present proposal aims to address this gap in knowledge regarding optimal psychosocial treatment strategies for children suffering from depressive disorders. We propose a 2-site randomized controlled trial to evaluate the efficacy of Family Focused Treatment (FFT), as compared to an individual client-centered psychotherapy (IP) modeled after "usual" community care. FFT adopts an interpersonal model for understanding how depressive symptoms are maintained, emphasizes developing family skills/strategies for altering interpersonal processes, and works on building a family environment that supports recovery and enhances stress resistance and resilience. This approach may be particularly appropriate to the developmental needs of depressed children, given their dependence on parents, the potential of FFT to address the needs of multiple family members, and our data supporting benefits on depression, functioning, and other co-occurring symptoms. The proposed project will enroll 140 children (ages 8-12) with depressive disorders. Children will be randomly assigned to receive a 14-week trial of either FFT or IP. At study entry, immediately post-treatment, and at a 9-month post-treatment follow-up all participants will undergo intensive evaluation of clinical state and psychosocial and family functioning.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
December 31, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Principal Investigator
Principal Investigator

Martha C. Tompson

Associate Professor

Boston University Charles River Campus

Eligibility Criteria

Inclusion Criteria

  • current Depressive Disorder
  • ages 7-13 years
  • living with at least one biological parent willing to participate

Exclusion Criteria

  • thought disturbance
  • severe conduct disorders
  • unstable on antidepressant medications
  • continuation in current non-study treatment
  • non-English speaking

Outcomes

Primary Outcomes

Adequate Depression Treatment Response

Time Frame: 3 months

50% improvement on Children's Depression Rating Scale-Revised

Secondary Outcomes

  • Children's Self-Report of Depression Symptoms(3 Months)
  • Interviewer-rated Depression Severity(3 Months)

Study Sites (2)

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