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Reaching Out to Adolescents With Depression (ROAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01140464
First Posted: June 9, 2010
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
Kaiser Permanente
University of Washington
Information provided by (Responsible Party):
Laura Richardson, Seattle Children's Hospital
  Purpose
Major Depression is one of the most common mental health disorders in adolescence and is associated with significant impairments in development and functioning. This project will rigorously test the Adolescent Collaborative Care Treatment intervention, a health services intervention designed to improve management for depressive disorders among adolescents, via a randomized controlled trial comparing the intervention to usual care. Key components of the trial include enhanced education for youth and parents, youth involvement in choice of evidence-based treatments, care management by an allied health professional with regular supervision by a mental health specialist and pediatrician, and stepped care to advance treatment when youth are not improving. Additional features have been added to engage adolescents and parents including a moderated message board for youth to share with and learn from one another, formalized involvement of the parent, and availability of the care manager during after school hours. Our findings will provide key information on the effectiveness of a developmentally-sensitive adapted collaborative care intervention for the treatment of adolescent depression.

Condition Intervention
Depression Other: Collaborative care Other: Enhanced Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Adolescent Collaborative Care Treatment for Depression

Further study details as provided by Laura Richardson, Seattle Children's Hospital:

Primary Outcome Measures:
  • Child Depression Rating Scale [ Time Frame: 12 months ]
    Depressive symptoms


Secondary Outcome Measures:
  • Columbia Impairment Scale [ Time Frame: 12 months ]
    Functional impairment


Enrollment: 101
Study Start Date: April 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enhanced Usual Care
Usual care treatment of depression in primary care settings. Usual care considered enhanced as patients and their parents were given screening results and encouraged to seek care from their primary care doctor and behavioral health services.
Other: Enhanced Usual Care
Provision of screening results to provider, teen and parent with recommendation to seek further care
Active Comparator: Collaborative Care
Collaborative care intervention for depression. Involves care management, evidence based treatments in primary care setting, symptom monitoring and stepped care design
Other: Collaborative care
Provision of depression care management in the primary care setting to improve delivery of evidence based treatments

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • depression
  • age 13-17 years
  • enrollment in study Primary Care Clinics

Exclusion Criteria:

  • suicidality
  • already enrolled Specialty mental health care
  • mental health hospitalization in the prior year
  • substance abuse
  • bipolar disorder
  • non-English speaker
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140464


Locations
United States, Washington
Group Health Cooperative
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Seattle Children's Hospital
National Institute of Mental Health (NIMH)
Kaiser Permanente
University of Washington
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laura Richardson, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01140464     History of Changes
Other Study ID Numbers: R01MH085645 ( U.S. NIH Grant/Contract )
First Submitted: June 1, 2010
First Posted: June 9, 2010
Last Update Posted: May 1, 2017
Last Verified: April 2017

Keywords provided by Laura Richardson, Seattle Children's Hospital:
Adolescents

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