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Systems of Support Study for Childhood Depression (SOS)

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ClinicalTrials.gov Identifier: NCT01159041
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : January 24, 2018
Sponsor:
Collaborators:
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Martha C. Tompson, 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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Family Focused Treatment (FFT) Behavioral: Individual Treatment (IP) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Family Focused Treatment for Childhood Depression
Study Start Date : January 2010
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Adequate Depression Treatment Response [ Time Frame: 3 months ]
    50% improvement on Children's Depression Rating Scale-Revised


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159041


Locations
United States, California
UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, United States, 90095
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University Charles River Campus
University of California, Los Angeles
National Institute of Mental Health (NIMH)

Publications of Results:
Other Publications:
Responsible Party: Martha C. Tompson, Associate Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT01159041     History of Changes
Other Study ID Numbers: 1R01MH082861 ( U.S. NIH Grant/Contract )
R01MH082856-01A2 ( U.S. NIH Grant/Contract )
R01MH082861-01A2 ( U.S. NIH Grant/Contract )
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Keywords provided by Martha C. Tompson, Boston University Charles River Campus:
Depression, children, adolescent, family

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders