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

Study Description

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

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• 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

Locations

United States, Pennsylvania

Western Psychiatric Institute & Clinic

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:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Laura Dietz, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02054312
• Other Study ID Numbers: MH079353
• First Posted: February 4, 2014
• Last Update Posted: December 30, 2015
• Last Verified: December 2015

Additional relevant MeSH terms:

Depressive Disorder; Mood Disorders; Mental Disorders