Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents
Phase II Study of Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents
1 other identifier
interventional
42
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 2, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedDecember 30, 2015
December 1, 2015
3.5 years
February 2, 2014
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)
EXPERIMENTALFamily 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.
Client Centered Therapy (CCT)
ACTIVE COMPARATORChild 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.
Interventions
Eligibility Criteria
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
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: 21352148BACKGROUNDDietz 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.
PMID: 25721184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura J Dietz, Ph.D.
University of Pittsburgh
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