Reaching Out to Adolescents With Depression (ROAD)

This study is ongoing, but not recruiting participants.

Sponsor:

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: March 20, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 1, 2010
Last Updated Date	March 20, 2013
Start Date ^ICMJE	April 2010
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 7, 2010)	Child Depression Rating Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ] Depressive symptoms
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01140464 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 7, 2010)	Columbia Impairment Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ] Functional impairment
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Reaching Out to Adolescents With Depression
Official Title ^ICMJE	Adolescent Collaborative Care Treatment for Depression
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Depression
Intervention ^ICMJE	Other: Collaborative care Provision of depression care management in the primary care setting to improve delivery of evidence based treatments
Study Arm (s)	Active Comparator: Usual Care Usual care treatment of depression in primary care settings. Intervention: Other: Collaborative care
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	160
Estimated Completion Date	April 2013
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	13 Years to 17 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01140464
Other Study ID Numbers ^ICMJE	R01MH085645, R01MH085645
Has Data Monitoring Committee	Yes
Responsible Party	Laura Richardson, Seattle Children's Hospital
Study Sponsor ^ICMJE	Seattle Children's Hospital
Collaborators ^ICMJE	National Institute of Mental Health (NIMH) Group Health Cooperative University of Washington
Investigators ^ICMJE	Not Provided
Information Provided By	Seattle Children's Hospital
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top