A Stepped Care Model of Adolescent Depression Treatment in Primary Care

NCT ID: NCT01443715

Last Updated: 2014-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-07-31

Brief Summary

It is challenging for depressed adolescents and their families to access specialized mental health services. A viable option is delivering treatment in the primary care clinic (PCC) setting; however, few effective models are currently available. The overall aim of this study is to assess in the pediatric PCC, the preliminary acceptability and feasibility of a novel collaborative stepped care model of treatment for depressed adolescents.

Detailed Description

Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy focusing on reducing depression symptoms and current interpersonal problems associated with depression. This stepped care model (SCIPT-A) first delivers a low intensity 6 session plus two parent session adaptation of IPT-A, a treatment designed for mild to moderate adolescent depression with impairment. The second phase in the model is for adolescents with persistent depressive symptoms who will receive 8 more sessions of IPT-A in combination with the addition of an antidepressant. The social worker clinicians (SW) currently employed in the PCC will be trained to deliver the Brief Interpersonal Psychotherapy for adolescents (BIPT-A)and in the second phase, the pediatrician will provide the medication treatment in collaboration with the SW clinician continuing to provide IPT-A. Fifty adolescents identified by their primary care pediatrician and meeting criteria for DSM-IV major depression, dysthymic disorder, or depression, not otherwise specified will be randomized to receive either treatment as usual (TAU) or the SCIPT-A model of stepped collaborative depression care in the PCC for 16 weeks. TAU consists of pediatrician referral of depressed adolescents to either a psychologist, social worker or child psychiatrist within the clinic or to another mental health agency in the community. All adolescents will be administered clinical interviews and self-report questionnaires during the 16 week protocol to assess treatment acceptability, feasibility, safety and preliminary change in symptoms. The project will provide information concerning the feasibility and acceptability of this treatment model for adolescent depression delivered by pediatricians and social work clinicians in pediatric primary care practice.

Conditions

Major Depressive Disorder; Dysthymia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stepped Care IPT-A - Interpersonal Psychotherapy

IPT-A focuses on communication and problem-solving skills.

Group Type: EXPERIMENTAL

Stepped Care IPT-A (SCIPT-A)

Intervention Type: BEHAVIORAL

Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy focusing on reducing depression symptoms and current interpersonal problems associated with depression.

Treatment as Usual

Treatment as Usual is the standard treatment received in the community

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Standard treatment in the community

Interventions

Stepped Care IPT-A (SCIPT-A)

Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy focusing on reducing depression symptoms and current interpersonal problems associated with depression.

Intervention Type: BEHAVIORAL

Treatment as Usual

Standard treatment in the community

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Males and females ages 13-20 years
• English and Spanish speaking adolescent
• Parent may be monolingual or bilingual in Spanish
• DSM-IV diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder Not Otherwise Specified
• Moderate impairment in functioning
• Moderate depression severity
• Willing to refrain from other medications unless provided by investigator or PCP during the study

Exclusion Criteria

• Diagnoses of Post Traumatic Stress Disorder , Obsessive Compulsive Disorder, current Substance abuse, Schizophrenia, bipolar disorder, Conduct disorder, Active eating disorder, Pervasive Developmental Disorder, Autism, Asberger's, Psychosis
• Engagement in severe self-injurious behavior in past 3 months
• Active suicidal ideation with plan or intent
• Mental retardation or severe learning disability
• Medical illness that may interfere with treatment
• Open Administration for Children's Services (ACS) case
• Pregnancy
• Already receiving psychotherapy or medication treatment for depression or have begun a medication trial for another diagnosis within the previous three months
• History of intolerance to fluoxetine or escitalopram
• Failed 2 completely adequate and documented Antidepressant trials
• Co-morbid Attention Deficit Hyperactivity Disorder if not on stable dose of stimulants

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Mufson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

1R34MH091320-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6432

Identifier Type: -

Identifier Source: org_study_id