Overview

This trial is active, not recruiting.

Condition depression
Treatments family focused treatment (fft), individual treatment (ip)
Phase phase 2
Sponsor Boston University
Collaborator University of California, Los Angeles
Start date January 2010
End date May 2015
Trial size 140 participants
Trial identifier NCT01159041, 1R01MH082861, R01MH082856-01A2, R01MH082861-01A2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
15 session family-based treatment emphasizing improving relationship skills to combat depression symptoms and support recovery.
family focused treatment (fft)
FFT is designed to specifically address the developmental needs of school-aged children and their parents through an emphasis on fostering positive and supportive parent-child interactions that scaffold the development of a positive self, to help parents provide the child additional positive feedback on his/her developmentally appropriate achievements, and to enhance family and child coping. This treatment is conducted with the child and his/her parent(s) and includes education about depression, communication training, relationship enhancement, and problem-solving.
(Active Comparator)
15 session individually-based treatment to assist children in understanding the causes of their symptoms.
individual treatment (ip)
The goals of the treatment are to foster the therapeutic relationship, to provide a supportive and empathic setting where the child can come to better understand his/her emotions/feelings and address issues underlying current symptoms. Therapeutic goals will be addressed through reflection and clarification of feelings/emotions and understanding the child's perception of the context of depressed feelings.

Primary Outcomes

Measure
Improvement in Depressive Disorder
time frame: 3 months
Improvement in Depressive Symptoms
time frame: 3 Months

Secondary Outcomes

Measure
Child-reported Depressive Symptoms
time frame: 3 Months
Parent Report of Associated Symptoms
time frame: 3 Months
Child's Social Functioning
time frame: 3 Months

Eligibility Criteria

Male or female participants from 7 years up to 13 years old.

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

Additional Information

Official title Evaluation of Family Focused Treatment for Childhood Depression
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Boston University.