An interventional study of E-cigarette & Tobacco Use Treatment Intervention in Vaping and Smoking, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged 14 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Treatment
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.
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).
160 studies on the registry are indexed under Vaping; 72 are open to participants now.
This study's enrollment of 144 is above the median of 110 across 135 interventional studies indexed under Vaping.
Browse Vaping studies →Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will complete the baseline survey and receive an informational brochure
Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey
Behavioral: E-cigarette & Tobacco Use Treatment Intervention
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.
Self-reported 30-day Abstinence
Self reported cessation, assessed at 3 month follow up survey.
Time frame: 3 month follow-up
Biochemically Verification of Past 30 Day Cessation
For participants who self-reported past 30 day cessation, an option was provided to biochemically verify cessation with a mailed saliva sample.
Time frame: 3 month follow-up
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Ratings from participants on perceived acceptability (i.e., satisfaction and usefulness) of the intervention
Time frame: Study completion (approximately 12 weeks)
Acceptability of Intervention - Utility of Intervention
Acceptability of the intervention assessed by intervention element completion rates (i.e. overall uptake of support resources).
Time frame: Study completion (approximately 12 weeks)
Feasibility of Intervention - Duration of Intervention
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.
Time frame: Study completion (approximately 12 weeks)
Feasibility of Intervention - Intervention Interruptions
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.
Time frame: Study completion (approximately 12 weeks)
Feasibility of Intervention - Health Educator Survey
Feasibility of the intervention as assessed by the health educator who delivered the intervention.
Time frame: Study completion (approximately 12 weeks)
Fidelity of Intervention Delivered by a Health Educator
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).
Time frame: Study completion (approximately 12 weeks)
| Milestone | Control | Intervention |
|---|---|---|
| Started | 48 | 96 |
| Completed | 38 | 58 |
| Not completed | 10 | 38 |
| Withdrew: Lost to follow-up | 10 | 38 |
Self reported cessation, assessed at 3 month follow up survey.
| Participants | Control | Intervention |
|---|---|---|
| Self-reported 30-day Abstinence | 16 | 25 |
For participants who self-reported past 30 day cessation, an option was provided to biochemically verify cessation with a mailed saliva sample.
| Participants | Intervention | Control |
|---|---|---|
| Agreed to do biochemical verification & successfully completed test | 1 | 2 |
| Agreed to do biochemical verification & did not complete test | 5 | 2 |
| Declined offer to complete biochemical verification test | 16 | 10 |
| Ineligible for to complete biochemical verification test due to tobacco use or NRT use | 36 | 24 |
Ratings from participants on perceived acceptability (i.e., satisfaction and usefulness) of the intervention
| Participants | Intervention |
|---|---|
| Satisfaction with the intervention — Not at all satisfied / Extremely unlikely | 0 |
| Satisfaction with the intervention — A little satisfied / Unlikely | 3 |
| Satisfaction with the intervention — Not sure satisfied / Neutral | 8 |
| Satisfaction with the intervention — Somewhat satisfied / Likely | 34 |
| Satisfaction with the intervention — Very satisfied / Extremely likely | 51 |
| Likely to recommend the intervention to friends or family — Not at all satisfied / Extremely unlikely | 1 |
| Likely to recommend the intervention to friends or family — A little satisfied / Unlikely | 3 |
| Likely to recommend the intervention to friends or family — Not sure satisfied / Neutral | 20 |
| Likely to recommend the intervention to friends or family — Somewhat satisfied / Likely | 37 |
| Likely to recommend the intervention to friends or family — Very satisfied / Extremely likely | 35 |
Acceptability of the intervention assessed by intervention element completion rates (i.e. overall uptake of support resources).
| Participants | Intervention |
|---|---|
| Made a quit plan during the index session | 47 |
| Were interested in nicotine replacement therapy during the index session | 14 |
| Were prescribed nicotine replacement therapy during the index session | 11 |
| Enrolled in a text-to-quit program during the index session | 13 |
| Were provided addiction resources information during the index session | 67 |
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.
| minutes | Intervention |
|---|---|
| Feasibility of Intervention - Duration of Intervention | 32 (28 to 39) |
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.
| number of interruptions | Intervention |
|---|---|
| Feasibility of Intervention - Intervention Interruptions | 0 (0 to 5) |
Feasibility of the intervention as assessed by the health educator who delivered the intervention.
| Participants | Intervention |
|---|---|
| Agreed/ Strongly Agreed the intervention was easy to deliver | 95 |
| Agreed/Strongly Agreed there was enough time to deliver the intervention | 94 |
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).
| scores on a scale | Intervention |
|---|---|
| Fidelity of Intervention Delivered by a Health Educator | 43 ± 3.1 |
Collected over From enrollment to the end of 3 month follow up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Intervention | 0/96 (0%) | 0/96 (0%) | 0/96 (0%) |
All enrolled participants completed the baseline survey.
| Age, Continuous(years) | Control | Intervention | Total |
|---|---|---|---|
| Mean | 16.2 ± 1.3 | 16.2 ± 1.3 | 16.2 ± 1.3 |
| Sex: Female, Male(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Female | 31 | 63 | 94 |
| Male | 17 | 33 | 50 |
| Ethnicity (NIH/OMB)(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 15 | 25 |
| Not Hispanic or Latino | 35 | 80 | 115 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Race (NIH/OMB)(Participants) | Control | Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 7 | 17 | 24 |
| White | 27 | 56 | 83 |
| More than one race | 9 | 16 | 25 |
| Unknown or Not Reported | 5 | 4 | 9 |
| Past 30 day e-cigarette use(Participants) | Control | Intervention | Total |
|---|---|---|---|
| 0 Days | 0 | 0 | 0 |
| 1-5 days (occasional) | 18 | 31 | 49 |
| 6-19 days (intermittent) | 12 | 24 | 36 |
| 20+ days (frequent) | 16 | 40 | 56 |
| Missing | 2 | 1 | 3 |
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Children's Mercy Hospital Kansas City