NCT02054312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

3.5 years

First QC Date

February 2, 2014

Last Update Submit

December 28, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Childhood Depression Rating Scale -Revised

    15 weeks

Study Arms (2)

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.

Behavioral: Family Based Interpersonal Psychotherapy (FB-IPT)

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.

Behavioral: Client Centered Therapy (CCT)

Interventions

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

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute & Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • 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.

    PMID: 21352148BACKGROUND
  • 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.

MeSH Terms

Conditions

Depressive Disorder

Interventions

Person-Centered Psychotherapy

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Laura J Dietz, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 2, 2014

First Posted

February 4, 2014

Study Start

October 1, 2010

Primary Completion

April 1, 2014

Study Completion

October 1, 2014

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations