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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02030782
Other study ID # HS009908
Secondary ID
Status Completed
Phase N/A
First received January 19, 2012
Last updated January 7, 2014
Start date October 1999
Est. completion date December 2003

Study information

Verified date December 2008
Source Agency for Healthcare Research and Quality (AHRQ)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 418
Est. completion date December 2003
Est. primary completion date December 2003
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 21 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- not English-speaking

- provider not in study

- sibling already in study

- completed eligibility screener previously

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Quality Improvement (QI) for depression
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.
Usual Care
Usual care enhanced by provider education regarding depression evaluation and management

Locations

Country Name City State
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States University of California Los Angeles California
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Venice Family Clinic Venice California
United States Ventura County Medical Center Ventura California

Sponsors (5)

Lead Sponsor Collaborator
Agency for Healthcare Research and Quality (AHRQ) Kaiser Permanente, RAND, University of Pittsburgh, Venice Family Clinic

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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;29 — View Citation

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. — View Citation

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):100 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/appi. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported depressive symptoms on the CES-D (Center for Epidemiologic Studies Depression Scale) 6-months No
Secondary 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 No
Secondary satisfaction with care 6 months with follow up at 12 and 18 months No
Secondary Rates of mental health care, counseling/psychotherapy, and medication treatment. Youth self report on the study version of the Service Assessment for Children & Adolescents provided measures of rates of mental health care(dichotomous indicator of whether any mental health treatment received), counseling/psychotherapy (dichotomous indicator of whether counseling/psychotherapy was received, number of counseling/psychotherapy sessions), and medication treatment (dichotomous indicator of whether youth received any medication treatment for mental health problems). These measures were obtained using . 6-months with follow-up at 12 and 18 months No
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