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Systems of Support Study for Childhood Depression (SOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Boston University
Sponsor:
Collaborators:
University of California, Los Angeles
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT01159041
First received: July 7, 2010
Last updated: June 27, 2011
Last verified: June 2011

July 7, 2010
June 27, 2011
January 2010
May 2014   (final data collection date for primary outcome measure)
  • Improvement in Depressive Disorder [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in Depressive Symptoms [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Depressive symptoms as rated by a trained assessor.
Same as current
Complete list of historical versions of study NCT01159041 on ClinicalTrials.gov Archive Site
  • Child-reported Depressive Symptoms [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • Parent Report of Associated Symptoms [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • Child's Social Functioning [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Same as current
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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)
    Intervention: Behavioral: Family Focused Treatment (FFT)
  • Active Comparator: Individual Treatment (IP)
    Intervention: Behavioral: Individual Treatment (IP)
Tompson MC, Pierre CB, Haber FM, Fogler JM, Groff AR, Asarnow JR. Family-focused treatment for childhood-onset depressive disorders: results of an open trial. Clin Child Psychol Psychiatry. 2007 Jul;12(3):403-20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
February 2015
May 2014   (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
Both
7 Years to 13 Years
No
United States
 
NCT01159041
1R01MH082861, R01MH082856-01A2, R01MH082861-01A2
Yes
Martha C. Tompson, Ph.D., Associate Professor, Boston University
Boston University
  • University of California, Los Angeles
  • National Institute of Mental Health (NIMH)
Not Provided
Boston University
June 2011

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