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

Depressive Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054312
• Other study ID #: MH079353
• Status: Completed
• Phase: N/A
• First received: February 2, 2014
• Last updated: December 28, 2015
• Start date: October 2010
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorders

Intervention

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

• Client Centered Therapy (CCT)

Locations

Country	Name	City	State
United States	Western Psychiatric Institute & Clinic	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Childhood Depression Rating Scale -Revised		15 weeks	No