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Reaching Out to Adolescents With Depression (ROAD)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative care
Enhanced Usual Care
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Adolescents

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Group Health Cooperative

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enhanced Usual Care

Collaborative Care

Arm Description

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.

Collaborative care intervention for depression. Involves care management, evidence based treatments in primary care setting, symptom monitoring and stepped care design

Outcomes

Primary Outcome Measures

Child Depression Rating Scale
Depressive symptoms

Secondary Outcome Measures

Columbia Impairment Scale
Functional impairment

Full Information

First Posted
June 1, 2010
Last Updated
April 27, 2017
Sponsor
Seattle Children's Hospital
Collaborators
National Institute of Mental Health (NIMH), Kaiser Permanente, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT01140464
Brief Title
Reaching Out to Adolescents With Depression
Acronym
ROAD
Official Title
Adolescent Collaborative Care Treatment for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
National Institute of Mental Health (NIMH), Kaiser Permanente, University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Adolescents

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Collaborative Care
Arm Type
Active Comparator
Arm Description
Collaborative care intervention for depression. Involves care management, evidence based treatments in primary care setting, symptom monitoring and stepped care design
Intervention Type
Other
Intervention Name(s)
Collaborative care
Intervention Description
Provision of depression care management in the primary care setting to improve delivery of evidence based treatments
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care
Intervention Description
Provision of screening results to provider, teen and parent with recommendation to seek further care
Primary Outcome Measure Information:
Title
Child Depression Rating Scale
Description
Depressive symptoms
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Columbia Impairment Scale
Description
Functional impairment
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Group Health Cooperative
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27654449
Citation
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.
Results Reference
derived
PubMed Identifier
25157724
Citation
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.
Results Reference
derived

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Reaching Out to Adolescents With Depression

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