Adolescent Inpatient Tobacco and ENDS Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Vaping
• Intervention / Treatment: Behavioral: E-cigarette & Tobacco Use Treatment Intervention

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will complete the baseline survey and receive an informational brochure
Experimental: Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported 30-day Abstinence	Self reported cessation, assessed at 3 month follow up survey.	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.	3 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program	Ratings from participants on perceived acceptability (i.e., satisfaction and usefulness) of the intervention	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).	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.	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.	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.	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).	Study completion (approximately 12 weeks)

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Abbey Masonbrink, MD, MPH, Children's Hospital Los Angeles

Publications and helpful links

General Publications

• Wooten S, Catley D, Miller MK, Wilson K, Richter KP, Masonbrink A. Treatment of e-cigarette use among hospitalised adolescents and young adults: a protocol for intervention development and evaluation of preliminary efficacy and implementation outcomes in a randomised controlled trial. BMJ Open. 2025 Jan 8;15(1):e094323. doi: 10.1136/bmjopen-2024-094323.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2025

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Cessation; Vaping
• Additional Relevant MeSH Terms: Behavior; Smoking; Vaping; Manufactured Materials; Technology, Industry, and Agriculture; Smoking Devices; Electronic Nicotine Delivery Systems
• Other Study ID Numbers: STUDY00002116; K23DA055736 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No