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Systems of Support Study for Childhood Depression (SOS)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Focused Treatment (FFT)
Individual Treatment (IP)
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, children, adolescent, family

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • UCLA Semel Institute for Neuroscience and Human Behavior
  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Focused Treatment (FFT)

Individual Treatment (IP)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Adequate Depression Treatment Response
50% improvement on Children's Depression Rating Scale-Revised

Secondary Outcome Measures

Interviewer-rated Depression Severity
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
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.

Full Information

First Posted
July 7, 2010
Last Updated
January 22, 2018
Sponsor
Boston University Charles River Campus
Collaborators
University of California, Los Angeles, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01159041
Brief Title
Systems of Support Study for Childhood Depression
Acronym
SOS
Official Title
Evaluation of Family Focused Treatment for Childhood Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
Collaborators
University of California, Los Angeles, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, children, adolescent, family

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Focused Treatment (FFT)
Arm Type
Experimental
Arm Description
15 session family-based treatment emphasizing improving relationship skills to combat depression symptoms and support recovery.
Arm Title
Individual Treatment (IP)
Arm Type
Active Comparator
Arm Description
15 session individually-based treatment to assist children in understanding the causes of their symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Family Focused Treatment (FFT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual Treatment (IP)
Intervention Description
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 Measure Information:
Title
Adequate Depression Treatment Response
Description
50% improvement on Children's Depression Rating Scale-Revised
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Interviewer-rated Depression Severity
Description
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.
Time Frame
3 Months
Title
Children's Self-Report of Depression Symptoms
Description
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.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UCLA Semel Institute for Neuroscience and Human Behavior
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17953128
Citation
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. doi: 10.1177/1359104507078474.
Results Reference
background
PubMed Identifier
22537731
Citation
Tompson MC, Boger KD, Asarnow JR. Enhancing the developmental appropriateness of treatment for depression in youth: integrating the family in treatment. Child Adolesc Psychiatr Clin N Am. 2012 Apr;21(2):345-84. doi: 10.1016/j.chc.2012.01.003. Epub 2012 Mar 17.
Results Reference
result
PubMed Identifier
28545757
Citation
Tompson MC, Sugar CA, Langer DA, Asarnow JR. A Randomized Clinical Trial Comparing Family-Focused Treatment and Individual Supportive Therapy for Depression in Childhood and Early Adolescence. J Am Acad Child Adolesc Psychiatry. 2017 Jun;56(6):515-523. doi: 10.1016/j.jaac.2017.03.018. Epub 2017 Apr 7.
Results Reference
result
PubMed Identifier
28966545
Citation
Tompson MC, Langer DA, Hughes JL, Asarnow JR. Family-Focused Treatment for Childhood Depression: Model and Case Illustrations. Cogn Behav Pract. 2017 Aug;24(3):269-287. doi: 10.1016/j.cbpra.2016.06.003.
Results Reference
result
PubMed Identifier
31840263
Citation
Asarnow JR, Tompson MC, Klomhaus AM, Babeva K, Langer DA, Sugar CA. Randomized controlled trial of family-focused treatment for child depression compared to individual psychotherapy: one-year outcomes. J Child Psychol Psychiatry. 2020 Jun;61(6):662-671. doi: 10.1111/jcpp.13162. Epub 2019 Dec 15.
Results Reference
derived

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Systems of Support Study for Childhood Depression

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