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A Stepped Care Model of Adolescent Depression Treatment in Primary Care (SCIPT-A)

Primary Purpose

Major Depressive Disorder, Dysthymia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stepped Care IPT-A (SCIPT-A)
Treatment as Usual
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, Dysthymia, Depressive Disorder Not Otherwise Specified (DDNOS)

Eligibility Criteria

13 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepped Care IPT-A - Interpersonal Psychotherapy

Treatment as Usual

Arm Description

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

Treatment as Usual is the standard treatment received in the community

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The proportion of adolescents who agree to be randomized and enrolled in the study protocol
Acceptability of randomization will be determined by the proportion of adolescents from the total eligible who agree to be randomized and enrolled in the study protocol.

Full Information

First Posted
September 28, 2011
Last Updated
September 2, 2014
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01443715
Brief Title
A Stepped Care Model of Adolescent Depression Treatment in Primary Care
Acronym
SCIPT-A
Official Title
A Stepped Care Model of Adolescent Depression Treatment in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Dysthymia
Keywords
MDD, Dysthymia, Depressive Disorder Not Otherwise Specified (DDNOS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stepped Care IPT-A - Interpersonal Psychotherapy
Arm Type
Experimental
Arm Description
IPT-A focuses on communication and problem-solving skills.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as Usual is the standard treatment received in the community
Intervention Type
Behavioral
Intervention Name(s)
Stepped Care IPT-A (SCIPT-A)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Standard treatment in the community
Primary Outcome Measure Information:
Title
Feasibility based on proportionality
Description
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.
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
The proportion of adolescents who agree to be randomized and enrolled in the study protocol
Description
Acceptability of randomization will be determined by the proportion of adolescents from the total eligible who agree to be randomized and enrolled in the study protocol.
Time Frame
Up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Mufson, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Stepped Care Model of Adolescent Depression Treatment in Primary Care

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