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Clinical Trials/NCT02054312
NCT02054312CompletedNot Applicable

Phase II Study of Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents

University of Pittsburgh1 site in 1 country42 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1
Primary Endpoint
Childhood Depression Rating Scale -Revised

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
7 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •current depressive disorder
  • •one parent must be willing to participate in treatment

Exclusion Criteria

  • •bipolar disorder
  • •recent abuse
  • •developmental delay
  • •autism spectrum disorder

Arms & Interventions

Family Based Interpersonal Psychotherapy (FB-IPT)

Experimental

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: Family Based Interpersonal Psychotherapy (FB-IPT) (Behavioral)

Client Centered Therapy (CCT)

Active Comparator

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: Client Centered Therapy (CCT) (Behavioral)

Outcomes

Primary Outcomes

Childhood Depression Rating Scale -Revised

Time Frame: 15 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laura Dietz

Assistant Professor

University of Pittsburgh

Study Sites (1)

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