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

NCT ID: NCT02054312

Last Updated: 2015-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-10-31

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.

Conditions

Depressive Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Family Based Interpersonal Psychotherapy (FB-IPT)

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.

Group Type: EXPERIMENTAL

Family Based Interpersonal Psychotherapy (FB-IPT)

Intervention Type: BEHAVIORAL

Client Centered Therapy (CCT)

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.

Group Type: ACTIVE_COMPARATOR

Client Centered Therapy (CCT)

Intervention Type: BEHAVIORAL

Interventions

Family Based Interpersonal Psychotherapy (FB-IPT)

Intervention Type: BEHAVIORAL

Client Centered Therapy (CCT)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Laura Dietz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura J Dietz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Western Psychiatric Institute & Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21352148 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25721184 (View on PubMed)

Other Identifiers

MH079353

Identifier Type: -

Identifier Source: org_study_id