NCT01140464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

June 1, 2010

Last Update Submit

April 27, 2017

Conditions

Depression

Keywords

Adolescents

Outcome Measures

Primary Outcomes (1)

  • Child Depression Rating Scale

    Depressive symptoms

    12 months

Secondary Outcomes (1)

  • Columbia Impairment Scale

    12 months

Study Arms (2)

Enhanced Usual Care

ACTIVE COMPARATOR

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

Collaborative Care

ACTIVE COMPARATOR

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

Other: Collaborative care

Interventions

Collaborative careOTHER

Provision of depression care management in the primary care setting to improve delivery of evidence based treatments

Collaborative Care
Enhanced Usual CareOTHER

Provision of screening results to provider, teen and parent with recommendation to seek further care

Enhanced Usual Care

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • depression
  • age 13-17 years
  • enrollment in study Primary Care Clinics

You may not qualify if:

  • suicidality
  • already enrolled Specialty mental health care
  • mental health hospitalization in the prior year
  • substance abuse
  • bipolar disorder
  • non-English speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Cooperative

Seattle, Washington, 98101, United States

Location

Related Publications (2)

  • 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.

    PMID: 27654449DERIVED

  • 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.

    PMID: 25157724DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 9, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 1, 2017

Record last verified: 2017-04

Locations

US(1)