Systems of Support Study for Childhood Depression (SOS)

Boston University Charles River Campus

Status: Completed

Conditions: Depression

Treatments: Behavioral: Individual Treatment (IP); Behavioral: Family Focused Treatment (FFT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01159041

R01MH082856-01A2 (U.S. NIH Grant/Contract)

R01MH082861-01A2 (U.S. NIH Grant/Contract)

1R01MH082861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 7 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

Family Focused Treatment (FFT)

Experimental group

Description:

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

Treatment:

Behavioral: Family Focused Treatment (FFT)

Individual Treatment (IP)

Active Comparator group

Description:

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

Treatment:

Behavioral: Individual Treatment (IP)