Clinical trial NCT01443715: A Stepped Care Model of Adolescent Depression Treatment in Primary Care
Official title: A Stepped Care Model of Adolescent Depression Treatment in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Dysthymia
Keywords: MDD
Dysthymia
Depressive Disorder Not Otherwise Specified (DDNOS)
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 48
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility based on proportionality
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: The proportion of adolescents who agree to be randomized and enrolled in the study protocol
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University
name: Laura Mufson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: