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Reaching Out to Adolescents With Depression (ROAD)
This study has been completed.
Sponsor:
Seattle Children's Hospital
Collaborators:
National Institute of Mental Health (NIMH)
Group Health Cooperative
University of Washington
Information provided by (Responsible Party):
Laura Richardson, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01140464
First received: June 1, 2010
Last updated: April 27, 2017
Last verified: April 2017
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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| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01140464
Please refer to this study by its ClinicalTrials.gov identifier: 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)
Group Health Cooperative
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 ) |
| Study First Received: | June 1, 2010 |
| Last Updated: | April 27, 2017 |
Keywords provided by Laura Richardson, Seattle Children's Hospital:
|
Adolescents |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 18, 2017