Working… Menu

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

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. Identifier: NCT02054312
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : December 30, 2015
Information provided by (Responsible Party):
Laura Dietz, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depressive Disorders Behavioral: Family Based Interpersonal Psychotherapy (FB-IPT) Behavioral: Client Centered Therapy (CCT) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents
Study Start Date : October 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
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.
Behavioral: Client Centered Therapy (CCT)

Primary Outcome Measures :
  1. Childhood Depression Rating Scale -Revised [ Time Frame: 15 weeks ]

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.

Layout table for eligibility information
Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02054312

Layout table for location information
United States, Pennsylvania
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Layout table for investigator information
Principal Investigator: Laura J Dietz, Ph.D. University of Pittsburgh
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Laura Dietz, Assistant Professor, University of Pittsburgh Identifier: NCT02054312    
Other Study ID Numbers: MH079353
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Mood Disorders
Mental Disorders