We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Systems of Support Study for Childhood Depression (SOS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Martha C. Tompson, Boston University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159041
First Posted: July 9, 2010
Last Update Posted: July 21, 2015
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.
Collaborators:
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Martha C. Tompson, Boston University
  Purpose
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 Intervention Phase
Depression Behavioral: Family Focused Treatment (FFT) Behavioral: Individual Treatment (IP) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Family Focused Treatment for Childhood Depression

Further study details as provided by Martha C. Tompson, Boston University:

Primary Outcome Measures:
  • Improvement in Depressive Disorder [ Time Frame: 3 months ]
  • Improvement in Depressive Symptoms [ Time Frame: 3 Months ]
    Depressive symptoms as rated by a trained assessor.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
University of California, Los Angeles
National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
Responsible Party: Martha C. Tompson, Associate Professor, Boston University
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 Submitted: July 7, 2010
First Posted: July 9, 2010
Last Update Posted: July 21, 2015
Last Verified: July 2015

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

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