Systems of Support Study for Childhood Depression (SOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01159041
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : January 24, 2018
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Martha C. Tompson, Boston University Charles River Campus

July 7, 2010
July 9, 2010
January 24, 2018
January 2010
May 2015   (Final data collection date for primary outcome measure)
Adequate Depression Treatment Response [ Time Frame: 3 months ]
50% improvement on Children's Depression Rating Scale-Revised
  • Improvement in Depressive Disorder [ Time Frame: 3 months ]
  • Improvement in Depressive Symptoms [ Time Frame: 3 Months ]
    Depressive symptoms as rated by a trained assessor.
Complete list of historical versions of study NCT01159041 on Archive Site
  • Interviewer-rated Depression Severity [ Time Frame: 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.
  • Children's Self-Report of Depression Symptoms [ Time Frame: 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.
  • 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 ]
Not Provided
Not Provided
Systems of Support Study for Childhood Depression
Evaluation of Family Focused Treatment for Childhood Depression
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Behavioral: 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.
  • 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.
  • Experimental: Family Focused Treatment (FFT)
    15 session family-based treatment emphasizing improving relationship skills to combat depression symptoms and support recovery.
    Intervention: Behavioral: Family Focused Treatment (FFT)
  • Active Comparator: Individual Treatment (IP)
    15 session individually-based treatment to assist children in understanding the causes of their symptoms.
    Intervention: Behavioral: Individual Treatment (IP)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 31, 2016
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years to 13 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
1R01MH082861( U.S. NIH Grant/Contract )
R01MH082856-01A2 ( U.S. NIH Grant/Contract )
R01MH082861-01A2 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Martha C. Tompson, Boston University Charles River Campus
Boston University Charles River Campus
  • University of California, Los Angeles
  • National Institute of Mental Health (NIMH)
Not Provided
Boston University Charles River Campus
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP