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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
144
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.
Children's Mercy Hospital
Kansas City, Missouri, United States
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)
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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)