DepressionYPICNCT02030782
Youth Partners in Care: Depression and Quality Improvement
A study testing Quality Improvement (QI) for depression in people with Depression, run by Agency for Healthcare Research and Quality (AHRQ) at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Depression
- What is being tested?
- Quality Improvement (QI) for depression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 1999to Dec 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- not English-speaking
- provider not in study
- sibling already in study
- completed eligibility screener previously
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of California
Los Angeles, California, 90024
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California
University of Pittsburgh
Pittsburgh, Pennsylvania
Venice Family Clinic
Venice, California
Ventura County Medical Center
Ventura, California
About this study
Official title: Youth Partners in Care: Depression & Quality Improvement
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.
- Conditions
- Depression
- Being tested
- Quality Improvement (QI) for depression, Usual Care
- Keywords
- depression, quality improvement, treatment, adolescents
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement (QI) for depressionOther
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 CareOther
Usual care enhanced by provider education regarding depression evaluation and management
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: Quality Improvement (QI) for depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported depressive symptoms on the CES-D (Center for Epidemiologic Studies Depression Scale)
Measured: 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.
Measured: 6 months, with follow up at 12 and 18 months
satisfaction with care
Measured: 6 months with follow up at 12 and 18 months
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 .
Measured: 6-months with follow-up at 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startOct 1999
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Collaborators
- RAND, Kaiser Permanente, University of Pittsburgh, Venice Family Clinic
- Responsible party
- Sponsor
- Investigators
- Joan R Asarnow, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030782
- Sponsor's protocol ID
- HS009908
- Acronym
- YPIC
- Status last verified
- Dec 2008
- First submitted
- 19 Jan 2012
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12222079Wells 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.
PubMed 11430853Asarnow 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.
PubMed 19651711Asarnow 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.
PubMed 15657324Jaycox 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.
PubMed 16502131Asarnow 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.
PubMed 16310125Ngo 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.
PubMed 19797376Tang 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.
PubMed 18937226Goldstein 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.
PubMed 18018807Fordwood 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.
PubMed 17658983
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Partners in Care: Depression & Quality Improvement
- ClinicalTrials.gov ID
- NCT02030782
- Acronym / sponsor ID
- YPIC / HS009908
- Conditions
- Depression
- Keywords
- depression, quality improvement, treatment, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Collaborators
- RAND, Kaiser Permanente, University of Pittsburgh, Venice Family Clinic
- Study start
- Oct 1999
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CarePatients received usual care through primary care, enhanced by provider education regarding depression evaluation and management (1-2 hour training, plus study manual) |
| Quality Improvement for Depression | Experimental | Other: Quality Improvement (QI) for depressionMajor 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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- not English-speaking
- provider not in study
- sibling already in study
- completed eligibility screener previously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality Improvement (QI) for depressionMajor 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 for Depression |
| Usual CareUsual care enhanced by provider education regarding depression evaluation and management | Other | Usual Care |
Primary outcome
Self-reported depressive symptoms on the CES-D (Center for Epidemiologic Studies Depression Scale)
Time frame: 6-months
3 secondary outcomes
mental health related quality of life as assessed using self-report on the Medical Outcomes Study Short Form 12 Health Survey.
Time frame: 6 months, with follow up at 12 and 18 months
satisfaction with care
Time frame: 6 months with follow up at 12 and 18 months
Rates of mental health care, counseling/psychotherapy, and medication treatment.
Time frame: 6-months with follow-up at 12 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
- Background: PubMed 12222079Asarnow 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.
- Background: PubMed 11430853Wells 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.
- Results publication: PubMed 19651711Asarnow 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.
- Results publication: PubMed 15657324Asarnow 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.
- Results publication: PubMed 16502131Jaycox 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.
- Results publication: PubMed 16310125Asarnow 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.
- Results publication: PubMed 19797376Ngo 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.
- Results publication: PubMed 18937226Tang 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.
- Results publication: PubMed 18018807Goldstein 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.
- Results publication: PubMed 17658983Fordwood 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan R Asarnow, PhD principal investigator
University of California, Los Angeles
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Improvement (QI) for depression in people with Depression, run by Agency for Healthcare Research and Quality (AHRQ) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported depressive symptoms on the CES-D (Center for Epidemiologic Studies Depression Scale) (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02030782, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.