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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Laura Dietz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02054312
First received: February 2, 2014
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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 Intervention
Depressive Disorders
Behavioral: Family Based Interpersonal Psychotherapy (FB-IPT)
Behavioral: Client Centered Therapy (CCT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Childhood Depression Rating Scale -Revised [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: October 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054312

Contacts
Contact: Laura J Dietz, Ph.D. 412-246-5632 dietzlj@upmc.edu

Locations
United States, Pennsylvania
Western Psychiatric Institute & Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Laura J Dietz, Ph.D. University of Pittsburgh
  More Information

Publications:
Responsible Party: Laura Dietz, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02054312     History of Changes
Other Study ID Numbers: MH079353
Study First Received: February 2, 2014
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014