in progress

Draft Research Plan

Tobacco and Nicotine Use Prevention and Cessation in Children and Adolescents: Primary Care Interventions

February 29, 2024

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.

    1.  Do primary care interventions to prevent tobacco or nicotine use or improve tobacco or nicotine cessation rates in children and adolescents improve health outcomes and reduce the likelihood of tobacco or nicotine use in adulthood?
    2. Do primary care interventions to reduce or prevent tobacco or nicotine use improve tobacco or nicotine cessation rates or prevent use in children and adolescents?
    3. What adverse effects are associated with primary care interventions to prevent tobacco or nicotine use or improve tobacco or nicotine cessation rates in children and adolescents?

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

  1. What is the relationship between use of tobacco products, use of electronic nicotine delivery systems, and use of cannabis products in children and adolescents?
  2. What tobacco or nicotine cessation and prevention interventions are offered or referred by primary care providers in their clinical practices?
  3. Does the uptake of tobacco or nicotine cessation and prevention interventions in primary care settings vary based on patient or family characteristics (e.g., gender, race and ethnicity, LBGTQ+ status, socioeconomic status, or geography)?

To the extent possible, we plan to describe the participant characteristics and major intervention components of the included studies. Data on population characteristics will help us explore the degree to which the findings are broadly representative of the U.S. population, including individuals in groups based on age; sex and gender; racial, ethnic, and cultural identity; socioeconomic status; and geographic region. Evidence will be evaluated to determine if there are common components of efficacious interventions and, to the extent possible, whether interventions tailored to specific groups tend to have larger effect sizes than those that are not tailored. As part of our effort to address health equity, we will search for and highlight interventions that demonstrate effectiveness in groups of individuals who historically have higher rates of tobacco or nicotine use and in traditionally stigmatized or underrepresented groups.

The proposed 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 Review. Criteria are overarching as well as specific to each of the Key Questions.

Category Included Excluded
  • Adolescents (ages 13–18 years) and children (age <13 years)
  • More than 50% of study participants must be in included age group
  • Pregnant adolescents
  • Adults (age >18 years), unless subgroup results for adolescents are reported separately from adults
  • Trials limited to children or adolescents with health issues that would limit generalizability to general primary care patients
Settings Primary care, other health care, research clinic/office, dental clinic, or school-based health clinic
  • Schools (other than health clinics delivering primary care)
  • Inpatient settings
  • Institutional/residential facilities
  • Primary care–relevant behavioral counseling interventions, including individual, group, phone, or technology-based sessions; telephone quit lines; apps; and health care system–level interventions
  • Adjunctive use of pharmacotherapy (nicotine replacement therapy, bupropion, or varenicline tartrate)
  • Interventions targeting parents or caregivers as a means to prevent or reduce tobacco or nicotine use in children and adolescents
  • Complementary and alternative medicine treatments, such as acupuncture and hypnosis
  • Broad public health or policy interventions
  • Use of ENDS as a cessation or prevention intervention
  • Trials in which participants are highly likely to know one another (i.e., closed social groups or peer counseling) and participant interaction is likely
  • Interventions that target marijuana use only
  • Usual care
  • Minimal care (no more than one single brief contact per year or brief written materials, such as pamphlets)
  • No intervention
  • Attention control
  • Wait list
Active intervention (more intensive than a single, brief contact per year or brief written materials)
Outcomes KQ 1:
  • Prevalence or severity of asthma, chronic bronchitis, or other respiratory disorders, and health care utilization for respiratory disorders
  • Dental/oral health outcomes
  • Cardiovascular health outcomes
  • Rate, incidence, or prevalence of adult tobacco and nicotine use
KQ 2:
  • Tobacco or nicotine use cessation
  • Tobacco or nicotine use prevention
  • Frequency or quantity of use of other substances (e.g., alcohol or marijuana
KQ 3: Any adverse effect occurring after initiation of the intervention  (e.g., paradoxical increase in tobacco and nicotine use or mental health issues)
Attitudes or knowledge about tobacco; intentions to quit
Study Design KQs 1, 2:
  • Randomized, controlled trials
  • Trials with a minimum of 6 months (or 24 weeks) of followup postbaseline

KQ 3:

  • Randomized and nonrandomized, controlled trials; comparative observational designs
KQs 1–3: All other study designs, including systematic reviews

KQs 1, 2: Studies with less than 6 months (or 24 weeks) of followup postbaseline

Timing No minimum followup required None

Abbreviations: ENDS=electronic nicotine delivery system; KQ=key question.