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Completed

NCT Number: NCT05936099

Adolescent Inpatient Tobacco and ENDS Intervention

The purpose of this study is to develop and evaluate an evidence-based intervention to assist adolescents and young adults with current vaping to quit vaping and smoking.

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Key information

Conditions

Age range

14 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

Use of electronic nicotine delivery system (ENDS), which are noncombustible tobacco products (e.g., e-cigarettes), has increased dramatically among youth and is associated with numerous adverse health outcomes as well as use of alcohol and other illicit substances. National guidelines recommend counseling to address tobacco use at every adolescent clinical visit; however, many at-risk adolescents do not routinely attend primary care. Although evidence supports treatment of tobacco use during an adult hospitalization, no interventions have been developed or tested in the pediatric hospital setting. Based on promising theoretically-based evidence from the primary care and hospital settings, we will design, iteratively refine and assess implementation of a novel tobacco and ENDS use intervention for hospitalized adolescents and young adults (AYAs). We do so by conducting a randomized controlled pilot study (n=144) with 3-month follow up to evaluate preliminary efficacy as well as implementation outcomes (i.e., acceptability, feasibility, fidelity).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admitted to the hospital
  • Screens positive for past 30 day e-cigarette use
  • Parent/guardian agrees to leave the room

Exclusion criteria

  • Age is less than 14 years or over 21 years
  • Not comfortable speaking/reading English
  • Too ill to participate
  • Severe psychiatric illness
  • Too developmentally delayed/cognitively impaired

Treatment and study plan

E-cigarette & Tobacco Use Treatment Intervention

Behavioral

The behavioral intervention includes health education on vaping health risk and outcomes, motivational interviewing, and assisted quit planning from a health educator and counseling and nicotine replacement therapy (if appropriate) provided by a physician.

Primary outcomes

  1. Self-reported 30-day Abstinence

    Time frame: 3 month follow-up

    Self reported cessation, assessed at 3 month follow up survey.

  2. Biochemically Verification of Past 30 Day Cessation

    Time frame: 3 month follow-up

    For participants who self-reported past 30 day cessation, an option was provided to biochemically verify cessation with a mailed saliva sample.

Secondary outcomes

  1. Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program

    Time frame: Study completion (approximately 12 weeks)

    Ratings from participants on perceived acceptability (i.e., satisfaction and usefulness) of the intervention

  2. Acceptability of Intervention - Utility of Intervention

    Time frame: Study completion (approximately 12 weeks)

    Acceptability of the intervention assessed by intervention element completion rates (i.e. overall uptake of support resources).

  3. Feasibility of Intervention - Duration of Intervention

    Time frame: Study completion (approximately 12 weeks)

    Assessment of the feasibility of the intervention based on information about delivery gathered from the computerized decision making system (CDS) such as the duration of the intervention.

  4. Feasibility of Intervention - Intervention Interruptions

    Time frame: Study completion (approximately 12 weeks)

    Assessment of the feasibility of the intervention based on information about delivery gathered from the computerized decision making system (CDS) such as the number of interruptions (by clinical staff, parents, or others) that occurred during intervention delivery.

  5. Feasibility of Intervention - Health Educator Survey

    Time frame: Study completion (approximately 12 weeks)

    Feasibility of the intervention as assessed by the health educator who delivered the intervention.

  6. Fidelity of Intervention Delivered by a Health Educator

    Time frame: Study completion (approximately 12 weeks)

    Extent of fidelity achieved in intervention delivery by a health educator. The mean score was calculated from 0 (never/very poor) to 5 (always/very good) for each of the 10 fidelity rating questions, which were summed, with a maximum possible score of 50. The scale utilized was an adapted version of the Motivational Interviewing Treatment Integrity tool (MITI).

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Development and Implementation of a Tobacco and ENDS Use Intervention for Adolescents and Young Adults in the Pediatric Hospital

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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