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Final Research Plan

Drug Use, Illicit: Primary Care Interventions for Children and Adolescents

May 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 is 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 January 15 until February 11, 2013 at 5:00 p.m., ET. 

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Select Text Description below for details.

Text Description.

This figure is the analytic framework that depicts the three key questions (KQs) to be addressed in the systematic review. The figure illustrates how interventions to reduce the illicit or nonmedical use of drugs may improve health, social, and legal outcomes (KQ 1) in children and adolescents (age 18 years and younger) who may or may not be currently using drugs. The figure also depicts how these interventions may also influence behaviors such as preventing drug use initiation and reducing the frequency and/or quantity of misuse (KQ 2). The figure also depicts whether these interventions have any potential harms (KQ 3).

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  1. Do primary care–relevant behavioral counseling interventions for drug use, with or without referral, improve mortality, morbidity, and other long-term outcomes in children and adolescents?
    1. Do outcomes differ in subgroups (e.g., as defined by age, risk level, sex, race, ethnicity, types of substances used)?
    2. What are elements of efficacious interventions?
    3. What criteria are used to identify children and adolescents for primary care drug use interventions?
  2. Do primary care–relevant behavioral counseling interventions, with or without referral, prevent drug use initiation in children and adolescents who do not currently use drugs or reduce drug use in children and adolescents who currently use drugs?
    1. Do outcomes differ in subgroups (e.g., as defined by age, risk level, sex, race, ethnicity, types of substances used)?
    2. What are elements of efficacious interventions?
    3. What criteria are used to identify children and adolescents for primary care drug use interventions?
  3. What are the adverse effects of primary care–relevant behavioral counseling drug use interventions?
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  1. What are the performance characteristics of currently available primary care–feasible screening instruments to detect drug use and/or misuse in children and adolescents?
  2. Are children and adolescents identified as misusing drugs or at risk for drug misuse through primary care screening comparable with patients who are included in effective primary care treatment?
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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 key questions.

  Include Exclude
Aim Preventing and/or reducing drug use is a primary aim, with or without addressing other substances or behaviors (e.g., addressing drug use and alcohol and tobacco use, addressing drug use and risky sexual behaviors) Targeting another behavior is only aim (e.g., alcohol misuse, tobacco use); that is, change in drug use is not a stated aim, but is the reported outcome
Condition Children or adolescents who are at the following stages of use: 1) never use, 2) experimentation, 3) regular use, or 4) problem use

Use of the following drugs:

  • Cannabinoids (marijuana, hashish*, synthetic marijuana*)
  • Prescription drugs for nonmedical purposes* (opioid pain relievers, central nervous system depressants, stimulants)
  • Stimulants (cocaine, amphetamine*, methamphetamine*)
  • Opioids (heroin, opium*)
  • Club drugs* (MDMA [ecstasy], flunitrazepam, gamma hydroxybutyrate [GHB])
  • Dissociative drugs* (ketamine, phencyclidine [PCP] and analogs, Salvia divinorum, dextromethorphan [DXM])
  • Hallucinogens* (lysergic acid diethylamide [LSD or acid], mescaline, psilocybin)
  • Inhalants* (also known as volatile substances)
  • Other emerging drugs* (Salvia, synthetic cathinones [bath salts])
  • Use of over-the-counter drugs for psychoactive purposes (e.g., cough and cold medicines, sleep aids)
  • Combination of the above drugs

*Not included in 2008 review
  • Diagnosis of drug abuse or dependence (according to the Diagnostic and Statistical Manual of Mental Disorders IV, Text Revision [DSM-IV-TR]) or drug use disorder (DSM V); studies of children and adolescents narratively described as “substance abusing” will be included
  • Medical use of drugs as prescribed
  • Nonpsychoactive drugs (e.g., anabolic steroids, laxatives, aspirin)
Population Children and adolescents (age <18 years) (includes studies
in which >50% of participants are age <18 years OR the subgroup of participants age <18 years is analyzed and reported separately from adults), including trials limited to targeted groups with cognitive, mental health, or other health issues and trials limited to pregnant adolescents
  • Adults (ages >18), unless adolescent subgroup results are reported separately from adult results
  • Treatment-seeking children or adolescents
  • Trials in which >50% of the sample have severe mental health issues such as schizophrenia, bipolar disorder, major depression, or acute psychosis
  • Trials in which >50% of the sample are diagnosed with drug abuse or dependence (DSM-IV-TR) or a drug use disorder (DSM V)
  • Trials limited to other groups not generalizable to primary care: psychiatric inpatients, individuals in juvenile detention centers, court-mandated, juvenile offenders
Interventions Primary care–relevant** behavioral counseling interventions designed primarily to prevent or reduce the nonmedical use of drugs, with or without referral. Including, but not limited to: advice, brief intervention†, motivational interviewing, action plans, written materials, and personalized feedback

**Conducted in primary care (i.e., office-based) or judged to be feasible or applicable to primary care:

  • Whom targeted: Individual-level identification
  • Who delivered: Usually involves primary care staff (primary care clinicians [family medicine, internal medicine, pediatrics], nurses, nurse practitioners, physician assistants, or related clinical staff [social workers, health educators, other counselors]) in some direct or indirect way or is seen as connected to the health care system by participant
  • How delivered: To individuals or in small groups (15 or less). Generally involves no more than eight group sessions total, and intervention time period is no longer than 12 months
  • Where delivered: Located anywhere, as long as linked to health care (e.g., clinic, research setting, community, home, or interactive technologies [Web, text messaging])‡ OR primary care–referable, such that the intervention is conducted as part of a health care setting or is widely available in the community (i.e., open enrollment)

†Typically delivered to those individuals at low to moderate risk. Goal is to provide education or advice, increase motivation to avoid substance use, or to teach behavior change skills that will reduce substance use as well as the chances of negative consequences. Usually involves 1 to 2 sessions each lasting 5 minutes to 1 hour

‡Interventions that only include electronic modes for intervention delivery (e.g., Web-based, CD-ROMs) that are not conducted in or connected to health care will also be included in the review
  • Detoxification, medically managed withdrawal, or opioid substitution therapy (methadone maintenance programs)
  • Maintaining abstinence after substance use treatment for abuse or dependence (i.e., secondary abstinence)
  • Broad public health, media, or policy interventions
  • Trials within closed (pre-existing) social networks (e.g., worksites, churches, schools)
  • Inpatient/residential treatment (short- or long-term)
  • Contingency management/vouchers
  • Vocational rehabilitation/Customized Employment Supports
  • Outward Bound/Life Skills Training
  • Payer-level interventions aimed at influencing patient utilization
Comparators
  • No intervention
  • Usual care
  • Waitlist
  • Attention control (e.g., similar in format and intensity, but intervention on a different content area)
  • Minimal intervention (no more than one single brief contact [<5 minutes] per year, or brief written materials, such as pamphlets)
 Active intervention (i.e., more than a single brief contact per year or brief written materials); comparative effectiveness
Outcomes KQ 1: (health, social, educational, and other outcomes):

Health outcomes:

  • All-cause mortality
  • Drug-related mortality (intentional and unintentional)
  • Drug-related morbidity (including, but not limited to: mental health disorders, sexually transmitted infection/HIV transmission, hepatitis B or C transmission, unintended pregnancies/pregnancy complications, respiratory infections, cardiovascular complications, stroke, seizures)
  • Drug-related injury or accidents
  • Other risky behaviors (e.g., alcohol, tobacco, other drug use; risky sexual behaviors)
  • Nonfatal overdoses
  • Quality of life

Social, educational, or other outcomes:

  • Health care utilization
  • Global functioning
  • Educational attainment/school performance
  • Social/legal outcomes (e.g., incarcerations, out-of-home juvenile placements, criminal activity, violence, drugged driving)
  • Family functioning

KQ 2: (behavioral outcomes)

(Based on self-report or toxicology screen; will favor outcomes with biochemical verification)

  • No use
  • Frequency of use
  • Quantity of use

KQ 3: (adverse events)

  • Serious treatment-related harms at any time point after the intervention began (e.g., death, seizure, cardiovascular event, or other medical issue requiring urgent medical treatment)
  • Paradoxical increase in drug use
  • Demoralization due to failed quit attempt
  • Attitudes, knowledge, beliefs related to drug use
  • Intention to change behavior
  • Intervention participation/compliance
Outcome assessment timing ≥6-month followup postbaseline assessment (26 weeks)

(Note: Studies with shorter followup will not be excluded at the title/abstract review phase so that the number of studies that would be excluded for this reason only can be evaluated)

 <6-month followup postbaseline assessment
Setting
  • Primary care settings
  • Emergency departments
  • Other settings included if study is linked to primary care or other health care, including: research clinics/offices, community centers, home, and virtual (e.g., online support groups)
  • Substance abuse treatment centers
  • School classrooms
  • Worksites
  • Inpatient/residential
  • Other institutions (e.g., juvenile detention facilities)
Study design KQs 1–3:
  • Randomized, controlled trials
  • Cluster-randomized, controlled trials
  • Nonrandomized, controlled clinical trials
 KQs 1–3:
  • Prospective or retrospective cohort studies
  • Case-control studies
  • Time series studies
  • Before-after studies
  • Cross-sectional studies
  • Editorials, commentaries, case studies, case series
Study geography Developed countries; rated “Very High” according to the 2011 Human Development Index: Andorra, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brunei Darussalam, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, China, Hungary, Iceland, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, United States Countries with a Human Development Index below “Very High”
Publication language English Any language other than English
Publication date 1992 to present Studies published before 1992
Quality rating Fair or good quality Poor quality

 

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The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from January 15 to February 11, 2013. The USPSTF reviewed and considered all comments when finalizing the Research Plan. Several comments suggested that the USPSTF broaden the age range to include young adults up to age 25 years, while other comments advocated including studies of patients who are seeking care for drug treatment; however, these populations are outside the scope of this review, which focuses on prevention in children and adolescents. A future update on this topic will focus on young adults and adults. The USPSTF received comments noting that interventions done in the emergency department might be appropriate for the primary care setting; studies that take place in the emergency department and meet other inclusion criteria were added to the inclusion criteria. A few other minor changes were made to clarify inclusion criteria and outcomes. One comment suggested that the review focus on all substances, including alcohol and tobacco; this approach will be considered in a future review.


Current as of May 2013

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