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Final Research Plan

Depression in Children and Adolescents: Screening

September 15, 2013

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Report forms the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from May 30 until June 26, 2013 at 5:00 p.m., ET.

Select Text Description below for details.

Text Description.

  1. Does screening for major depressive disorder (MDD) in children and adolescents in the primary care (or comparable) setting lead to improved health and other related outcomes overall and in subgroups defined by age, sex, or race/ethnicity?
  2. Are depression screening instruments for children and adolescents accurate in identifying MDD in primary care settings overall and in subgroups defined by age, sex, or race/ethnicity?
  3. Does screening increase the proportion of patients identified with MDD overall and in subgroups defined by age, sex, or race/ethnicity?
  4. What are the harms of screening for MDD in children and adolescents overall and in subgroups defined by age, sex, or race/ethnicity?
  5. Does treatment of MDD in children and adolescents identified in primary care improve health and other related outcomes overall and in subgroups defined by age, sex, or race/ethnicity?
  6. What are the harms of treatment of MDD in children and adolescents overall and in subgroups defined by age, sex, or race/ethnicity?

These key questions (KQs) reflect important changes since the 2009 review. All questions explicitly incorporate a subquestion on subgroups. In addition to the subgroup of primary interest in the 2009 review (age), these questions explicitly ask about sex and race/ethnicity subgroups.

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

Valid and reliable risk stratification tools may enhance the U.S. Preventive Services Task Force’s (USPSTF’s) ability to provide targeted recommendations for risk groups. Contextual information on uptake of existing recommendations may help tailor updated recommendations. Risk factors and uptake of USPSTF recommendations will be addressed via the following contextual questions.

  1. What proportion of primary care providers assess, treat, and refer child and adolescent patients with depression (MDD, dysthymia, and minor depression)? What proportion of providers have access to collaborative systems of care for these patients?
  2. What are the most common types of treatment of MDD in children and adolescents that can be initiated in or referred from primary care settings?
  3. Is there evidence of valid and reliable risk stratification tools to identify children and adolescents at high risk for MDD?
  4. In primary care, school, or comparable settings, are children and adolescents with MDD and comorbid mental health (e.g., attention deficit hyperactivity disorder, anxiety disorders) or chronic physical health conditions (e.g., diabetes, asthma) more likely to be screened, treated, or referred for treatment than children and adolescents with MDD only? Do they receive different treatment than children and adolescents without comorbid conditions?
  5. Is there evidence of effectiveness of serotonin–norepinephrine reuptake inhibitors (SNRIs), norepinephrine-dopamine reuptake inhibitors (NDRIs), or complementary and alternative medicine (CAM) treatments for child and adolescent MDD?

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Report. Criteria are overarching as well as specific to each of the KQs.

  Inclusion Exclusion
Populations KQs 1–4: Children and adolescents age 18 years or younger who are representative of a population seen in a primary care setting

KQs 5, 6: Children and adolescents age 18 years or younger who are representative of a population seen in a primary care or similar setting identified with MDD
  • Populations in which the majority of the sample is not age 18 years or younger, such as adults older than age 18 years
  • Mixed populations of adults and children without a separate analysis of pediatric outcomes (age 18 years or younger)
  • Population in which the sample is not representative of a population in a primary care setting, such as one sampled entirely from a specialty care population or from a population in which >50% of the sample has a medical condition (e.g., cancer) or other psychiatric disorder (e.g., eating disorder)
  • Screening for or treatment of minor depression, dysthymia, or other diagnoses without a separate analysis of MDD
Interventions: Screening
  • Screening instruments that are feasible for primary care or comparable settings; that is, instruments that take ≤15 minutes to complete if delivered prior to clinician and patient face-to-face contact (e.g., in the waiting or examination room, before clinician entrance), ≤5 minutes or five questions if used during the face-to-face visit, and feasible to score in primary care settings
  • More general mental health screening tools, if they have a depression module or are being used to identify depressive illness and related outcomes
  • Screening instruments that are not feasible for primary care or comparable settings; that is, instruments that take >15 minutes to complete if delivered prior to clinician and patient face-to-face contact (e.g., in the waiting or examination room, before clinician entrance), >5 minutes or five questions if used during the face-to-face visit, or not feasible to score in primary care settings
  • More general mental health screening tools, if they do not have a depression module and are not being used to identify depressive illness
Interventions: Treatment Pharmacological interventions:
  • Selective serotonin reuptake inhibitors: fluoxetine, fluvoxamine, sertraline, citalopram, and escitalopram

Psychotherapy interventions:

  • Cognitive-behavioral therapy
  • Interpersonal psychotherapy

Other interventions:

  • Pure or guided self-help
  • Family support
  • Parental education
  • Peer support
  • Collaborative care interventions
  • Other interventions not specifically listed in the exclusion criteria

Combined interventions:

  • Combinations of pharmacological, psychological, behavioral, or other interventions
 Pharmacological interventions:
  • Tricyclic antidepressants
  • Monoamine oxidase inhibitors
  • Paroxetine
  • SNRIs, NDRIs, other types of off-label pharmacological interventions

Other therapy:

  • CAM
  • Electroconvulsive therapy
  • Other interventions that are not primary care feasible or referable
Comparisons KQs 1, 3, 4:
  • Screened vs. unscreened

KQ 2:

  • Screening instrument vs. gold standard diagnostic instrument

KQ 5:

  • Medications vs. placebo
  • Nonpharmacological vs. wait-list control, usual care, or supportive counseling
  • Intervention vs. sham

KQ 6:

  • Medications vs. placebo
  • Intervention vs. wait-list control
  • Intervention vs. usual care
  • Intervention vs. sham
 KQs 1, 3–6:
  • Single-group design with no comparator
  • Active comparator of screening instrument (KQs 1–4) or treatment (KQs 5, 6)
Outcomes KQ 1:

Primary outcomes of interest:

  • Remission from MDD
  • Depressive symptoms (severity)

Additional outcomes of interest:

  • Health status, quality of life
  • Academic, psychosocial, and global functioning
  • High-risk behaviors (e.g., delinquency, unplanned pregnancy, substance use)
  • Mental or physical health symptoms
  • Suicidality or death

KQ 2:

  • Sensitivity
  • Specificity
  • Positive predictive value
  • Receiver operator curve characteristics (area under the curve)

KQ 3:

  • MDD diagnosis

KQ 4:

  • False-positive results leading to unnecessary treatment
  • Stigma
  • Opportunity costs
  • Resources (staff needed to perform screening and training for staff on the use of screening instruments)

KQ 5:

Primary outcomes of interest

  • Remission from MDD
  • Depressive symptoms or severity
  • Recurrence of MDD

Additional outcomes of interest

  • Health status, quality of life
  • Academic, psychosocial, and global functioning
  • High-risk behaviors (e.g., delinquency, unplanned pregnancy, substance use)
  • Mental or physical health symptoms

KQ 6:

Suicidality or death

  • Death from suicide or other causes
  • Other serious psychiatric events (such as hospitalization, suicidal ideation, and suicide attempts)
  • Triggering symptoms of mania
  • Discontinuation of medication due to adverse events
  • Side effects of medications
 KQs 1, 3, 4–6: All other outcomes not listed in inclusion criteria
Timing KQs 1, 3, 5: Outcomes reported at 6-week followup or later

KQ 2: Diagnostic accuracy compared with an independent standard, assessed at ≤2 months after the screening test

 KQs 1, 3, 5: Outcomes reported earlier than 6 weeks following screening or treatment

KQ 2: Diagnostic accuracy compared with an independent standard, assessed at >2 months after the screening test
Settings KQs 1, 3:
  • Primary care settings
  • United States and other countries with a very high Human Development Index

KQs 2, 4:

  • Primary care-, school-, or nonclinic-based settings (e.g., church or after school)
  • United States and other countries with a very high Human Development Index

KQs 5, 6:

  • Primary care
  • Outpatient settings that receive referrals from primary care settings
  • United States and other countries with a very high Human Development Index
 KQs 1, 3:
  • Settings not comparable with a primary care setting (e.g., mental health specialty settings)
  • Inpatients or those in residential or drug treatment programs; conducted with incarcerated populations
  • Countries with a Human Development Index of low to high

KQs 2, 4:

  • Settings not comparable with a primary care-, school-, or nonclinic-based setting (e.g., mental health specialty settings)
  • Inpatients or those in residential treatment or drug treatment programs; conducted with incarcerated populations
  • Countries with a Human Development Index of low to high

KQs 5, 6:

  • Inpatients or those in residential or drug treatment programs; conducted with incarcerated populations
  • Countries with a Human Development Index of low to high
Study Designs KQs 1, 3, 4–6:
  • Randomized, controlled trials
  • Controlled clinical trials
  • Systematic reviews published since 2011

Criteria specific to KQ 2:

  • Test/retest studies (test compared with gold standard) that are stand alone or incorporated within other study designs

Criteria specific to KQ 4:

  • Prospective cohort studies with sample size ≥1,000
  • Retrospective cohort studies with sample size ≥1,000

Criteria specific to KQ 6:

  • Prospective cohort studies with a sample size ≥1,000
  • Retrospective cohort studies with a sample size ≥1,000
 KQs 1, 3, 4–6:
  • Letters to the editor without primary data
  • Commentaries
  • Editorials
  • Case reports
  • Case series
  • Systematic reviews published since 2011

Criteria specific to KQs 1, 3:

  • Prospective or retrospective cohort studies

Criteria specific to KQ 2:

  • Does not report sensitivity and specificity compared with an independently assessed criterion standard for MDD

Criteria specific to KQ 4:

  • Prospective cohort studies with a sample size <1,000
  • Retrospective cohort studies with a sample size <1,000

Criteria specific to KQ 6:

  • Prospective cohort studies with a sample size <1,000
  • Retrospective cohort studies with a sample size <1,000
Language English Non-English
Date of Publication Any date subsequent to the latest date searched in the prior review Any date included in the prior review

 

The draft Research Plan was posted for public comment on the USPSTF Web site from May 30 to June 26, 2013. In response to comments, the USPSTF clarified the target group to be screened for depression in primary care and removed the lower age limit to also include children younger than age 7 years. The revised Research Plan also more clearly defines the focus on screening and treatment of major depressive disorder and specifies settings that are appropriate to answer each key question. The majority of the population must be representative of a primary care population; thus, the Research Plan excludes studies in which a majority of the participants have a comorbid physical or mental illness. The USPSTF added severity of depression as an outcome and split the second contextual question into two separate questions. Finally, the classes of interventions will be grouped into “pharmacologic” versus “psychotherapeutic” and other interventions.