- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01443715
A Stepped Care Model of Adolescent Depression Treatment in Primary Care (SCIPT-A)
September 2, 2014 updated by: New York State Psychiatric Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 20 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Stepped Care IPT-A - Interpersonal Psychotherapy
IPT-A focuses on communication and problem-solving skills.
|
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
|
Standard treatment in the community
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility based on proportionality
Time Frame: Up to 16 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of adolescents who agree to be randomized and enrolled in the study protocol
Time Frame: Up to 16 weeks
|
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.
|
Up to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laura Mufson, Ph.D., Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (ACTUAL)
June 1, 2014
Study Completion (ACTUAL)
July 1, 2014
Study Registration Dates
First Submitted
September 28, 2011
First Submitted That Met QC Criteria
September 29, 2011
First Posted (ESTIMATE)
September 30, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
September 4, 2014
Last Update Submitted That Met QC Criteria
September 2, 2014
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6432 (Other Identifier: LSHTM ethics reference number)
- 1R34MH091320-01A1 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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