A Stepped Care Model of Adolescent Depression Treatment in Primary Care

NCT01443715 | Completed Phase 2 DMC

• 2 other identifiers: 64321R34MH091320-01A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Dysthymia

Keywords

MDD; Dysthymia; Depressive Disorder Not Otherwise Specified (DDNOS)

Outcome Measures

Primary Outcomes (1)

• Feasibility based on proportionality

  The investigators will demonstrate the feasibility of the model by calculating the proportion of: 1) adolescent who attend SCIPT-A sessions, 2) adolescents stepped to Phase II who attend their pediatric appointments for medication management, 3) adolescents in Phase II who accepted and followed the medication treatment recommendation, 4) social workers' who were willing and able to learn the SCIPT-A model as demonstrated by displaying fidelity to the treatment model.

  Up to 16 weeks

Secondary Outcomes (1)

• The proportion of adolescents who agree to be randomized and enrolled in the study protocol

  Up to 16 weeks

Study Arms (2)

Stepped Care IPT-A - Interpersonal Psychotherapy

EXPERIMENTAL

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

Behavioral: Stepped Care IPT-A (SCIPT-A)

Treatment as Usual

ACTIVE COMPARATOR

Treatment as Usual is the standard treatment received in the community

Behavioral: Treatment as Usual

Interventions

Stepped Care IPT-A (SCIPT-A) 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.

Stepped Care IPT-A - Interpersonal Psychotherapy

Treatment as Usual BEHAVIORAL

Standard treatment in the community

Treatment as Usual

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Dysthymic Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Laura Mufson, Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: September 30, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 4, 2014

Record last verified: 2013-04

Locations

US (1)