NCT02030782

Brief Summary

This randomized effectiveness trial evaluates a quality improvement intervention aimed at providing access to evidence-based depression treatments (particularly cognitive-behavior therapy for depression and or pharmacotherapy) through primary care for youth ages 13-21, as compared to enhanced usual care. The major hypothesis is that the quality improvement intervention will be associated with improved outcomes, relative to enhanced usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
418

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Oct 1999

Longer than P75 for not_applicable depression

Geographic Reach
1 country

5 active sites

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

October 1, 1999

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
Last Updated

January 9, 2014

Status Verified

December 1, 2008

Enrollment Period

4.2 years

First QC Date

January 19, 2012

Last Update Submit

January 7, 2014

Conditions

Keywords

depressionquality improvementtreatmentadolescents

Outcome Measures

Primary Outcomes (1)

  • Self-reported depressive symptoms on the CES-D (Center for Epidemiologic Studies Depression Scale)

    6-months

Secondary Outcomes (3)

  • mental health related quality of life as assessed using self-report on the Medical Outcomes Study Short Form 12 Health Survey.

    6 months, with follow up at 12 and 18 months

  • satisfaction with care

    6 months with follow up at 12 and 18 months

  • Rates of mental health care, counseling/psychotherapy, and medication treatment.

    6-months with follow-up at 12 and 18 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Patients received usual care through primary care, enhanced by provider education regarding depression evaluation and management (1-2 hour training, plus study manual)

Other: Usual Care

Quality Improvement for Depression

EXPERIMENTAL

Major intervention components included a) expert leader teams who planned and implemented the intervention at each clinic, b) care managers who supported primary care clinicians with depression evaluation and management, c) access to cognitive-behavior therapy for depression within each primary care clinic, and d) patient and provider choice regarding treatment modality.

Other: Quality Improvement (QI) for depression

Interventions

Major intervention components included a) expert leader teams who planned and implemented the intervention at each clinic, b) care managers who supported primary care clinicians with depression evaluation and management, c) access to cognitive-behavior therapy for depression within each primary care clinic, and d) patient and provider choice regarding treatment modality.

Quality Improvement for Depression

Usual care enhanced by provider education regarding depression evaluation and management

Usual Care

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Met either of two criteria: 1) endorsed "stem items" for major depression or dysthymia from the 12-month Composite International Diagnostic Interview(CIDI-12,2.1) modified slightly to conform to diagnostic criteria for adolescents, 1-week or more of past-month depressive symptoms, and a total Center for Epidemiological Studies- Depression Scale(CES-D)40 score ≥ 16, or 2) CES-D score ≥ 24.
  • Age 13-21
  • Presented at primary care clinic

You may not qualify if:

  • not English-speaking
  • provider not in study
  • sibling already in study
  • completed eligibility screener previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California

Los Angeles, California, 90024, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Location

Venice Family Clinic

Venice, California, United States

Location

Ventura County Medical Center

Ventura, California, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

Related Publications (10)

  • Asarnow JR, Jaycox LH, Anderson M. Depression among youth in primary care models for delivering mental health services. Child Adolesc Psychiatr Clin N Am. 2002 Jul;11(3):477-97, viii. doi: 10.1016/s1056-4993(02)00006-8.

    PMID: 12222079BACKGROUND
  • Wells KB, Kataoka SH, Asarnow JR. Affective disorders in children and adolescents: addressing unmet need in primary care settings. Biol Psychiatry. 2001 Jun 15;49(12):1111-20. doi: 10.1016/s0006-3223(01)01113-1.

    PMID: 11430853BACKGROUND
  • Asarnow JR, Jaycox LH, Tang L, Duan N, LaBorde AP, Zeledon LR, Anderson M, Murray PJ, Landon C, Rea MM, Wells KB. Long-term benefits of short-term quality improvement interventions for depressed youths in primary care. Am J Psychiatry. 2009 Sep;166(9):1002-10. doi: 10.1176/appi.ajp.2009.08121909. Epub 2009 Aug 3.

  • Asarnow JR, Jaycox LH, Duan N, LaBorde AP, Rea MM, Murray P, Anderson M, Landon C, Tang L, Wells KB. Effectiveness of a quality improvement intervention for adolescent depression in primary care clinics: a randomized controlled trial. JAMA. 2005 Jan 19;293(3):311-9. doi: 10.1001/jama.293.3.311.

  • Jaycox LH, Asarnow JR, Sherbourne CD, Rea MM, LaBorde AP, Wells KB. Adolescent primary care patients' preferences for depression treatment. Adm Policy Ment Health. 2006 Mar;33(2):198-207. doi: 10.1007/s10488-006-0033-7.

  • Asarnow JR, Jaycox LH, Duan N, LaBorde AP, Rea MM, Tang L, Anderson M, Murray P, Landon C, Tang B, Huizar DP, Wells KB. Depression and role impairment among adolescents in primary care clinics. J Adolesc Health. 2005 Dec;37(6):477-83. doi: 10.1016/j.jadohealth.2004.11.123.

  • Ngo VK, Asarnow JR, Lange J, Jaycox LH, Rea MM, Landon C, Tang L, Miranda J. Outcomes for youths from racial-ethnic minority groups in a quality improvement intervention for depression treatment. Psychiatr Serv. 2009 Oct;60(10):1357-64. doi: 10.1176/ps.2009.60.10.1357.

  • Tang L, Duan N, Klap R, Asarnow JR, Belin TR. Applying permutation tests with adjustment for covariates and attrition weights to randomized trials of health-services interventions. Stat Med. 2009 Jan 15;28(1):65-74. doi: 10.1002/sim.3453.

  • Goldstein RB, Asarnow JR, Jaycox LH, Shoptaw S, Murray PJ. Correlates of "non-problematic" and "problematic" substance use among depressed adolescents in primary care. J Addict Dis. 2007;26(3):39-52. doi: 10.1300/J069v26n03_05.

  • Fordwood SR, Asarnow JR, Huizar DP, Reise SP. Suicide attempts among depressed adolescents in primary care. J Clin Child Adolesc Psychol. 2007 Jul-Sep;36(3):392-404. doi: 10.1080/15374410701444355.

MeSH Terms

Conditions

Depression

Interventions

Quality Improvement

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

EngineeringTechnology, Industry, and AgricultureQuality of Health CareHealth Services Administration

Study Officials

  • Joan R Asarnow, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

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
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 9, 2014

Study Start

October 1, 1999

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

January 9, 2014

Record last verified: 2008-12

Locations