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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01443715
First received: September 28, 2011
Last updated: September 2, 2014
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Dysthymia
Behavioral: Stepped Care IPT-A (SCIPT-A)
Behavioral: Treatment as Usual
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Stepped Care Model of Adolescent Depression Treatment in Primary Care

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Feasibility based on proportionality [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 48
Study Start Date: September 2011
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stepped Care IPT-A - Interpersonal Psychotherapy
IPT-A focuses on communication and problem-solving skills.
Behavioral: 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.
Active Comparator: Treatment as Usual
Treatment as Usual is the standard treatment received in the community
Behavioral: Treatment as Usual
Standard treatment in the community

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.

  Eligibility

Ages Eligible for Study:   13 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443715

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Laura Mufson, Ph.D. Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01443715     History of Changes
Other Study ID Numbers: 6432, 1R34MH091320-01A1
Study First Received: September 28, 2011
Last Updated: September 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
MDD
Dysthymia
Depressive Disorder Not Otherwise Specified (DDNOS)

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014