Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
NCT Number: NCT05936099
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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Notify MeUse 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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 month follow-up
Self reported cessation, assessed at 3 month follow up survey.
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.
Time frame: Study completion (approximately 12 weeks)
Ratings from participants on perceived acceptability (i.e., satisfaction and usefulness) of the 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).
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.
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.
Time frame: Study completion (approximately 12 weeks)
Feasibility of the intervention as assessed by the health educator who delivered the intervention.
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).
Children's Mercy Hospital Kansas City
Other
Development and Implementation of a Tobacco and ENDS Use Intervention for Adolescents and Young Adults in the Pediatric Hospital
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