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

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT02054312
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 0.9

Study Details

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)	N/A

Study Design

• Study Type: Interventional
• 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: Oct 1, 2010
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Oct 1, 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 [15 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 12 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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.

• Responsible Party: Laura Dietz, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02054312
• Other Study ID Numbers: MH079353
• First Posted: Feb 4, 2014
• Last Update Posted: Dec 30, 2015
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Depressive Disorder

Study Results

No Results Posted as of Dec 30, 2015