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Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laura Dietz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02054312
First received: February 2, 2014
Last updated: December 28, 2015
Last verified: December 2015

February 2, 2014
December 28, 2015
October 2010
April 2014   (final data collection date for primary outcome measure)
Childhood Depression Rating Scale -Revised [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02054312 on ClinicalTrials.gov Archive Site
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Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents
Phase II Study of Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents
The investigators proposed a preliminary randomized control trial of Family Based Interpersonal Psychotherapy (FB-IPT), a family-based adaptation of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A; Mufson et al., 2000). Forty-five preadolescent children (ages 8-12) diagnosed with a depressive disorder will be randomized to receive a 14-week course of FB-IPT or Client Centered Therapy (CCT), a supportive nondirective psychotherapy that closely approximates treatment at usual in community mental health clinics. In addition to assessing the feasibility and acceptability of randomization and each of the treatment conditions, this project will evaluate the effects of FB-IPT and CCT across multiple domains, including symptomatology and psychosocial functioning. Preadolescents will be assessed prior to treatment, during treatment (Weeks 3, 7, 11), one week post-treatment, and at 3 and 6 months post-treatment to compare changes in depressive symptoms, global, social, and family functioning. Data on psychosocial risk factors associated with onset and recurrence of preadolescent depression will be collected prior to treatment and at specified intervals post-treatment in order to conduct exploratory analyses on correlates of positive and negative treatment outcomes for Family Based IPT. This data will be used to generate future hypotheses about potential mediators and moderators that will be incorporated into an R01 application for an efficacy study of Family Based IPT.
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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depressive Disorders
  • Behavioral: Family Based Interpersonal Psychotherapy (FB-IPT)
  • Behavioral: Client Centered Therapy (CCT)
  • Experimental: Family Based Interpersonal Psychotherapy (FB-IPT)
    Family Based Interpersonal Psychotherapy for Depressed Preadolescents (FB-IPT) is a promising psychosocial treatment for preadolescent depression. It is conceptually rooted in an interpersonal model of depression that focuses on how stress in interpersonal relationships is often related to the onset or maintenance of depressive symptoms. In keeping with adult and adolescent models of IPT, FB-IPT focuses on improving the interpersonal functioning of individuals as a means to improve their depressive symptoms. FB-IPT addresses two domains of interpersonal impairment in depressed preadolescents, parent-child conflict and interpersonal avoidance, and focuses on family relationships, the primary context for children's social and emotional development.
    Intervention: Behavioral: Family Based Interpersonal Psychotherapy (FB-IPT)
  • Active Comparator: Client Centered Therapy (CCT)
    Child Centered Therapy (CCT), a supportive and nondirective treatment that closely approximates the standard of care for pediatric depression in community mental health. CCT is a manualized treatment for children between the ages of 8-14 based on a Rogerian counseling model. In that model, changes in children's mood and behavior are initiated through their experience of a therapeutic relationship marked by unconditional positive regard, empathic understanding, and therapeutic genuineness.
    Intervention: Behavioral: Client Centered Therapy (CCT)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
October 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • current depressive disorder
  • one parent must be willing to participate in treatment

Exclusion Criteria:

  • bipolar disorder
  • PTSD
  • recent abuse
  • developmental delay
  • autism spectrum disorder
Both
7 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02054312
MH079353
No
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Laura Dietz, University of Pittsburgh
University of Pittsburgh
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Principal Investigator: Laura J Dietz, Ph.D. University of Pittsburgh
University of Pittsburgh
December 2015

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