Adolescent Inpatient Tobacco and ENDS Intervention

Not Applicable

Active, not recruiting

• Conditions: Vaping; Smoking
• Interventions: Behavioral: E-cigarette & Tobacco Use Treatment Intervention

• Registration Number: NCT05936099
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-07
• Study Start: 2023-08-01
• Primary Completion: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	E-cigarette & Tobacco Use Treatment Intervention	Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey

Primary Outcome Measures

Name	Time	Method
Self-reported 30-day abstinence	3 month follow up	Cessation verified with biochemical verification of a saliva sample

Secondary Outcome Measures

Name	Time	Method
Acceptability of intervention in pediatric inpatient hospital setting	End of study (enrollment completion)	Ratings from participants, participants' parent, and providers on perceived acceptability (i.e., satisfaction) of the intervention
Feasibility of intervention	End of study (enrollment completion)	Ratings from participants, participants' parent, and providers on perceived feasibility (i.e., utility or practicability) of the intervention
Fidelity of intervention delivered by a health educator	End of study (enrollment completion)	Extent of fidelity achieved in intervention delivery

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States