Systems of Support Study for Childhood Depression

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Family Focused Treatment (FFT); Behavioral: Individual Treatment (IP)

• Registration Number: NCT01159041
• Lead Sponsor: Boston University Charles River Campus

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-09
• Primary Completion: 2015-05
• Study Completion: 2016-12-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Focused Treatment (FFT)	Family Focused Treatment (FFT)	15 session family-based treatment emphasizing improving relationship skills to combat depression symptoms and support recovery.
Individual Treatment (IP)	Individual Treatment (IP)	15 session individually-based treatment to assist children in understanding the causes of their symptoms.

Primary Outcome Measures

Name	Time	Method
Adequate Depression Treatment Response	3 months	50% improvement on Children's Depression Rating Scale-Revised

Secondary Outcome Measures

Name	Time	Method
Children's Self-Report of Depression Symptoms	3 Months	Child Depression Inventory (CDI) is a 27-item self-report measure. Scores range from 0 to 54 with higher scores reflecting higher levels of symptoms.
Interviewer-rated Depression Severity	3 Months	Children's Depression Rating Scale-Revised (CDRS-R) measures depression severity over the past two weeks. The 17-item CDRS-R has total scores ranging from 17 to 113 with scores of 40 or greater considered indicative of a depression diagnosis. Used in pharmacological and psychosocial treatment studies, it provides comparability across studies.

Trial Locations

Locations (2)

UCLA Semel Institute for Neuroscience and Human Behavior; 🇺🇸 Los Angeles, California, United States

Boston University; 🇺🇸 Boston, Massachusetts, United States