Adolescent Inpatient Tobacco and ENDS Intervention

NCT05936099 | Completed Results

• 2 other identifiers: STUDY00002116K23DA055736
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaping; Smoking

Keywords

Vaping; Adolescents; Cessation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program

  Study completion (approximately 12 weeks)

• Acceptability of Intervention - Utility of Intervention

  Study completion (approximately 12 weeks)

• Feasibility of Intervention - Duration of Intervention

  Study completion (approximately 12 weeks)

• Feasibility of Intervention - Intervention Interruptions

  Study completion (approximately 12 weeks)

• Feasibility of Intervention - Health Educator Survey

  Study completion (approximately 12 weeks)

Study Arms (2)

Control

NO INTERVENTION

Participants will complete the baseline survey and receive an informational brochure

Intervention

EXPERIMENTAL

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

Interventions

E-cigarette & Tobacco Use Treatment Intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Admitted to the hospital
• Screens positive for past 30 day e-cigarette use
• Parent/guardian agrees to leave the room

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

• 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.

  PMID: 39779271 DERIVED

MeSH Terms

Conditions

Vaping; Smoking

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

We enrolled e-cigarette users at any stage of motivation to quit, which may have impacted intervention efficacy. Due to practical limitations participants and the research team were not blinded to study conditions which may have led to bias in the assessment of outcome. We relied on self-report which is susceptible to social desirability bias and had very low biochemical verification completion rates to confirm our primary outcome. As a single site study there is limited generalizability.

Results Point of Contact

• Title: Abbey Masonbrink
• Organization: Children's Hospital of Los Angeles

amasonbrink@chla.usc.edu

(323) 361-6410

Study Officials

• Abbey Masonbrink, MD, MPH

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Hospitalist, MD MPH

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 7, 2023
• Study Start: August 1, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2025
• Last Updated: February 9, 2026
• Results First Posted: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)