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

Primary Purpose

Depressive Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Based Interpersonal Psychotherapy (FB-IPT)
Client Centered Therapy (CCT)
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorders

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western Psychiatric Institute & Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Based Interpersonal Psychotherapy (FB-IPT)

Client Centered Therapy (CCT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Childhood Depression Rating Scale -Revised

Secondary Outcome Measures

Full Information

First Posted
February 2, 2014
Last Updated
December 28, 2015
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02054312
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Based Interpersonal Psychotherapy (FB-IPT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Client Centered Therapy (CCT)
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Family Based Interpersonal Psychotherapy (FB-IPT)
Intervention Type
Behavioral
Intervention Name(s)
Client Centered Therapy (CCT)
Primary Outcome Measure Information:
Title
Childhood Depression Rating Scale -Revised
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura J Dietz, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute & Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21352148
Citation
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.
Results Reference
background
PubMed Identifier
25721184
Citation
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.
Results Reference
derived

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

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