Final Research Plan

Illicit Drug Use in Children, Adolescents, and Young Adults: Primary Care-Based Interventions

August 30, 2018

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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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.

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 Review will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from May 10 until June 6, 2018 at 8:00 p.m., ET.

Figure 1 is an analytic framework that depicts three Key Questions to be addressed in the systematic review. The figure illustrates how interventions to prevent drug use in children, adolescents, and young adults without regular illicit or nonmedical drug use may result in improved health and related outcomes, including morbidity, mortality, and social, educational, and legal outcomes (Key Question 1), and behavioral outcomes, including drug abstinence, frequency or quantity of drug use, and other risky behaviors (Key Question 2). Additionally, the figure addresses whether interventions to reduce drug use among children, adolescents, and young adults without regular illicit or nonmedical drug use may result in any harms (Key Question 3).

  1. Do primary care–feasible or referable interventions to prevent drug use in children, adolescents, and young adults improve health outcomes or other related outcomes?
  2. Do primary care–feasible or referable interventions to prevent drug use in children, adolescents, and young adults improve drug use outcomes?
  3. What are the harms of primary care–feasible or referable interventions to prevent drug use in children, adolescents, and adults?

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 (KQs).

  Include Exclude
Aim Preventing illicit and nonmedical drug use is a primary study 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) Change in drug use is not a stated aim of the study but is a reported outcome
Condition Any use of psychoactive illicit drugs and nonmedical use of psychoactive prescription or over-the-counter medications, such as:
  • Cannabinoids (marijuana, hashish, synthetic marijuana)
  • Club drugs (3,4-methylenedioxymethamphetamine [MDMA or ecstasy], flunitrazepam [Rohypnol], gamma-hydroxybutyrate [GHB], synthetic cathinone [bath salts])
  • Dissociative drugs (ketamine, phencyclidine [PCP] and analogs, Salvia divinorum [salvia], dextromethorphan [DXM])
  • Hallucinogens (lysergic acid diethylamide [LSD or acid], N,N-dimethyltryptamine [DMT], mescaline, psilocybin)
  • Inhalants (also known as volatile substances)
  • Illicit opioids (heroin, opium, Mitragyna speciosa [kratom], illicitly manufactured fentanyl [IMF])
  • Stimulants (cocaine, amphetamine, Catha edulis [khat], methamphetamine)
  • Prescription opioid pain relievers
  • Prescription sedatives (barbiturates, benzodiazepines, sleep medications)
  • Prescription stimulants
  • Over-the-counter drugs (e.g., DXM)
  • Combination of any of the above
  • Medical use of drugs as prescribed
  • Nonpsychoactive drugs (e.g., anabolic steroids, laxatives, aspirin)
Population
  • Children, adolescents, and young adults (age ≤25 years), including pregnant females, who do not regularly use illicit drugs or medications for nonmedical psychoactive effects
  • A priori subpopulations of interest will be examined based on age (early childhood, preadolescent, adolescent, young adult), sex, race/ethnicity

 
  • Young persons who regularly use illicit drugs or prescription drugs for nonmedical effects, including harmful or hazardous use or drug abuse or dependence (DSM-IV-TR) or those with a drug use disorder (DSM-5)a
  • Children and adolescents seeking treatment for drug-related issuesa
  • Children and adolescents who are referred to treatment for drug-related issues by the juvenile justice system, a social or health agency, or their parents, or otherwise directly referred for substance abuse treatment in a specialty settinga
  • Trials limited to young persons with health issues (e.g., schizophrenia, HIV) that would limit generalizability to general primary care patients
Interventions
  • Counseling interventions designed to prevent and/or reduce illicit and nonmedical prescription drug use, with or without referral, including interventions targeting parents or caregivers to prevent and/or reduce drug use in young persons
  • Counseling interventions can vary in their approach (e.g., 12-step programs, cognitive behavioral therapy, motivational enhancement therapy), specific strategies (e.g., action plans, diaries), delivery method (e.g., in person, electronic, individual, group), length of contact (e.g., brief, extended), and number of contacts (e.g., single, multiple)
  • Detoxification, medically managed withdrawal, or medication-assisted treatment (e.g., methadone maintenance programs, buprenorphine, naltrexone)
  • Maintaining abstinence after substance use treatment for dependence or drug use disorder (i.e., secondary abstinence)
  • Broad public health, media, or policy interventions
  • Inpatient/residential treatment
  • Contingency management/vouchers
  • Vocational rehabilitation/customized employment supports
  • Outward Bound/life skills training
Comparators
  • No intervention
  • Usual care
  • Waitlist
  • Attention control (e.g., intervention is similar in format and intensity but on a different content area)
  • Minimal intervention (no more than one brief contact [i.e., <5 minutes] per year or brief written materials, such as pamphlets)
 Active intervention (i.e., more than one brief contact per year or brief written materials)
Outcomes KQ 1 (Health, social, educational, and other outcomes):

Health outcomes:

  • All-cause mortality
  • Drug-related mortality (intentional and unintentional)
  • Drug-related morbidity morbidity (including but not limited to: mental health disorders, STI/HIV transmission, hepatitis B or C virus transmission, unintended pregnancy/pregnancy complications, deep bacterial abscesses, endocarditis, respiratory infections, cardiovascular complications, stroke, seizures)
  • Drug-related injury or accidents
  • Nonfatal overdose
  • Quality of life
  • Pain
  • Other drug-related consequences

Social, educational, or other outcomes:

  • Health care utilization
  • Global functioning
  • Educational attainment/school performance
  • Social/legal outcomes (e.g., incarceration, out-of-home juvenile placement, criminal activity, violence, driving under the influence)
  • Family functioning
  • Other related social or educational outcomes

KQ 2 (Behavioral outcomes):

  • Drug use (required) (self-reported and/or biologic measures):
    • Abstinence (use/no use)
    • Frequency and/or quantity of use
    • Severity of substance use disorder (reported as an index measured by a standardized questionnaire, such as the Short Inventory of Problems, Addiction Severity Index, or Severity of Dependence Scale)
    • Composite substance use outcome
    • Other risky behaviors (e.g., alcohol, tobacco, or other drug use; risky sexual behaviors)

KQ 3 (Harms):

  • Serious treatment-related harms at any time point after the intervention began (e.g., death (including suicide), seizure, cardiovascular event, or other medical issue requiring urgent medical treatment)
  • Demoralization due to failed quit attempt
  • Harms associated with parents finding out about their children’s drug use
  • Discontinuation of effective treatment due to fears of addiction (e.g., medication for attention deficit hyperactivity disorder)
  • Attitudes, knowledge, or beliefs related to drug use
  • Intention to change behavior
  • Intervention participation/compliance
Outcome assessment timing At least 3 months after baseline measurement (except for studies in pregnant women, for which shorter length of follow-up will be included) Less than 3 months after baseline measurement
Setting
  • Primary care settings
  • Other primary care–relevant settings, including other health care clinics, emergency departments, research clinics/offices, school health clinics, community centers, homes, and virtual settings (e.g., online support groups)
  • Substance abuse treatment centers
  • School classrooms
  • Worksites
  • Inpatient/residential settings
  • Other institutions (e.g., juvenile detention facility)
Study design
  • Randomized, controlled trials
  • Cluster randomized, controlled trials
  • Nonrandomized, controlled trials
  • Prospective or retrospective cohort studies
  • Case-control studies
  • Time series studies
  • Before-after studies
  • Cross-sectional studies
  • Editorials, commentaries, case studies, or case series
Study geography Studies conducted in countries categorized as “Very High” on the 2015 Human Development Index (as defined by the United Nations Development Programme) Studies conducted in countries not categorized as “Very High” on the 2015 Human Development Index
Publication language English Languages other than English
Quality rating Fair- or good-quality studies Poor-quality studies (according to design-specific USPSTF criteria)

a Intervention trials in these populations are also included in the evidence review for a separate topic, “Primary Care Screening for Drug Use in Adolescents and Adults, Including Pregnant Women.”

Abbreviations: DSM-IV-TR = Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision; DSM-V = Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; STI = sexually transmitted infection.

The draft Research Plan was posted for public comment on the USPSTF Web site from May 10 to June 6, 2018. Since the draft Research Plan was developed, the scope of the USPSTF evidence review for a separate topic, “Primary Care Screening for Drug Use in Adolescents and Adults, Including Pregnant Women,” was expanded to include trials of interventions to reduce illicit and nonmedical drug use among persons with the full spectrum of unhealthy drug use, from regular or risky use through substance use disorder. This expansion represented substantial overlap with the scope originally proposed for the current evidence review. In response, the USPSTF decided to limit the focus of the current review to the prevention of illicit and nonmedical drug use in children, adolescents, and young adults who are nonusers or who have used illicit and nonmedical drugs only sporadically or experimentally (i.e., excluding trials targeting persons with regular or problematic use). Other changes, based on public comment, included specifying important subgroups for targeted analysis; aligning the inclusion criteria for young adults with those for children and adolescents; and adding the outcomes of deep bacterial abscesses, endocarditis, and discontinuation of effective treatment due to fears of addiction.