Systems of Support Study for Childhood Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Family Focused Treatment (FFT)

15 session family-based treatment emphasizing improving relationship skills to combat depression symptoms and support recovery.

Group Type EXPERIMENTAL

Family Focused Treatment (FFT)

Intervention Type BEHAVIORAL

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.

Individual Treatment (IP)

15 session individually-based treatment to assist children in understanding the causes of their symptoms.

Group Type ACTIVE_COMPARATOR

Individual Treatment (IP)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No