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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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adolescent Collaborative Care Treatment for Depression

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Child Depression Rating Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Depressive symptoms


Secondary Outcome Measures:
  • Columbia Impairment Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Functional impairment


Estimated Enrollment: 160
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care
Usual care treatment of depression in primary care settings.
 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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Laura Richardson, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01140464     History of Changes
Other Study ID Numbers: R01MH085645, R01MH085645
Study First Received: June 1, 2010
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
Adolescents

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

ClinicalTrials.gov processed this record on June 13, 2013