in progress

Final Research Plan

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

June 27, 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.

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Figure 1 is an analytic framework that depicts the pathway children and adolescents may go through to prevent and/or stop tobacco and/or nicotine use. Children and adolescents are assessed for tobacco and/or nicotine use, may undergo prevention and/or cessation interventions that may lead to prevention, reduced use, or cessation of tobacco or nicotine products, or other substance. Additional outcomes include morbidity, mortality, educational, legal and social outcomes, quality of life, and adult tobacco or nicotine use. Interventions may also lead to harms.

*In this research plan, tobacco refers to any tobacco product, including: cigarettes, cigars, hookah tobacco, and pipe tobacco; smokeless tobacco products, including dip, snuff, snus, and chewing tobacco; and non-tobacco nicotine products, including e-cigarettes, vapes, other electronic nicotine delivery systems, nicotine pouches, and nicotine gels. Tobacco does not refer to nicotine replacement therapy.

  1. Do primary care interventions to prevent initiation of tobacco* or increase tobacco cessation rates in children and adolescents improve health and related outcomes and reduce the likelihood of tobacco use in adulthood?
  2. Do primary care interventions to prevent initiation of tobacco or increase tobacco cessation rates in children and adolescents prevent tobacco use initiation, increase tobacco cessation, or decrease the use of other substances?
  3. What adverse effects or unintended consequences are associated with primary care interventions to prevent initiation of tobacco or increase tobacco cessation rates in children and adolescents?

*In this research plan, tobacco refers to any tobacco product, including: cigarettes, cigars, hookah tobacco, and pipe tobacco; smokeless tobacco products, including dip, snuff, snus, and chewing tobacco; and non-tobacco nicotine products, including e-cigarettes, vapes, other electronic nicotine delivery systems, nicotine pouches, and nicotine gels. Tobacco does not refer to nicotine replacement therapy.

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 (including use of electronic nicotine delivery systems) and use of cannabis products in children and adolescents?
  2. What tobacco cessation and prevention interventions are offered or referred by primary care providers in their clinical practices?
  3. Does the uptake of tobacco cessation and prevention interventions in primary care settings vary based on patient or family characteristics (e.g., gender, race and ethnicity, tobacco use in the household, LBGTQ+ status, socioeconomic status, mental health, disability, 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; LBGTQ+ status; racial, ethnic, and cultural identity; socioeconomic status; mental health; disability; 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 have disproportionately higher rates of tobacco use or have been historically marginalized, stigmatized, or underrepresented.

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

Category Included Excluded
Populations
  • Children and adolescents age ≤18 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
  • Studies not conducted in countries with a very high Human Development Index
Interventions
  • Primary care–relevant behavioral counseling interventions, including individual, group, phone, or technology-based sessions; telephone quit lines; apps; and health care system–level interventions
  • Pharmacotherapy or adjunctive use of pharmacotherapy (nicotine replacement therapy, bupropion, or varenicline tartrate)
  • Interventions targeting parents or caregivers as a means to prevent or reduce tobacco* 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; use of other nonmedicinal nicotine products (e.g., nicotine pouches)
  • 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
Comparisons
  • 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:

All ages, including adults:

  • Mortality
  • Symptoms and conditions associated with tobacco use (e.g., prevalence or severity of asthma, chronic bronchitis, or other respiratory disorders, dental and oral health outcomes, cardiovascular outcomes, mental health, substance use disorder diagnosis)

Children and adolescents only:

  • School-based outcomes (e.g., attendance, grades)
  • Social and legal outcomes (e.g., citations for tobacco use, social and family relations)
  • Quality of life

Adults only:

  • Tobacco use

KQ 2:

Children and adolescents only:

  • Tobacco use cessation
  • Tobacco use prevention

All ages including adults:

  • Use of other substances

KQ 3:

Children and adolescents only:
Any adverse effect occurring after initiation of the intervention (e.g., paradoxical increase in tobacco or nicotine use, mental health issues)
  • Attitudes or knowledge about tobacco; intentions to quit
  • Use of nicotine replacement therapy
Study Designs KQs 1, 2: Randomized, controlled trials with a minimum of 6 months (or 24 weeks) of followup post-baseline

KQ 3: Randomized trials and nonrandomized comparative studies that adjust for potential confounding variables

 KQs 1–3: All other study designs, including systematic reviews

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

*In this research plan, tobacco refers to any tobacco product, including: cigarettes, cigars, hookah tobacco, and pipe tobacco; smokeless tobacco products, including dip, snuff, snus, and chewing tobacco; and non-tobacco nicotine products, including e-cigarettes, vapes, other electronic nicotine delivery systems, nicotine pouches, and nicotine gels. Tobacco does not refer to nicotine replacement therapy.

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

The draft Research Plan was posted on the U.S. Preventive Services Task Force (USPSTF) website for public comment from February 29, 2024, to March 27, 2024. In response, the USPSTF revised the analytic framework to be consistent with other child/adolescent substance use topics to include health and related outcomes and behavioral outcomes. The inclusion/exclusion criteria were revised to reflect the population of interest for each outcome (i.e., child/adolescent and/or adult) and the outcomes were expanded to include social, legal, and educational outcomes, as well as quality of life. Additionally, the inclusion/exclusion criteria were edited to include only studies with a very high Human Development Index to be consistent with previous USPSTF reviews. The Key Questions were also edited for clarity and an explanatory footnote was added to explain that tobacco refers to both tobacco and nicotine products (with the exception of nicotine replacement therapy).