Reaching Out to Adolescents With Depression (ROAD)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Depression	Other: Collaborative care; Other: Enhanced Usual Care	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	101 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Health Services Research
Official Title:	Adolescent Collaborative Care Treatment for Depression
Study Start Date :	April 2010
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	April 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Child Depression Rating Scale [ Time Frame: 12 months ]
   Depressive symptoms

Secondary Outcome Measures :

1. Columbia Impairment Scale [ Time Frame: 12 months ]
   Functional impairment

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wright DR, Haaland WL, Ludman E, McCauley E, Lindenbaum J, Richardson LP. The Costs and Cost-effectiveness of Collaborative Care for Adolescents With Depression in Primary Care Settings: A Randomized Clinical Trial. JAMA Pediatr. 2016 Nov 1;170(11):1048-1054. doi: 10.1001/jamapediatrics.2016.1721.

Richardson LP, Ludman E, McCauley E, Lindenbaum J, Larison C, Zhou C, Clarke G, Brent D, Katon W. Collaborative care for adolescents with depression in primary care: a randomized clinical trial. JAMA. 2014 Aug 27;312(8):809-16. doi: 10.1001/jama.2014.9259.

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 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