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

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

Tracking Information

• First Submitted Date: February 2, 2014
• First Posted Date: February 4, 2014
• Last Update Posted Date: December 30, 2015
• Study Start Date: October 2010
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 3, 2014): Childhood Depression Rating Scale -Revised [ Time Frame: 15 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents
• Official Title: Phase II Study of Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Depressive Disorders

Intervention

• Behavioral: Family Based Interpersonal Psychotherapy (FB-IPT)
• Behavioral: Client Centered Therapy (CCT)

Study Arms

• 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)

Publications *

• Dietz LJ, Mufson L, Irvine H, Brent DA. Family-based interpersonal psychotherapy for depressed preadolescents: an open-treatment trial. Early Interv Psychiatry. 2008 Aug;2(3):154-61. doi: 10.1111/j.1751-7893.2008.00077.x.
• Dietz LJ, Weinberg RJ, Brent DA, Mufson L. Family-based interpersonal psychotherapy for depressed preadolescents: examining efficacy and potential treatment mechanisms. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):191-9. doi: 10.1016/j.jaac.2014.12.011. Epub 2014 Dec 30.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 28, 2015): 42
• Original Estimated Enrollment (submitted: February 3, 2014): 45
• Actual Study Completion Date: October 2014
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02054312
• Other Study ID Numbers: MH079353
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Laura Dietz, University of Pittsburgh
• Study Sponsor: University of Pittsburgh
• Collaborators: Not Provided

Investigators

• Principal Investigator: Laura J Dietz, Ph.D.; University of Pittsburgh

• PRS Account: University of Pittsburgh
• Verification Date: December 2015