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Clinical Trials/NCT05936099
NCT05936099
Completed
Not Applicable

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

Children's Mercy Hospital Kansas City1 site in 1 country144 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Control
Conditions
Vaping
Sponsor
Children's Mercy Hospital Kansas City
Enrollment
144
Locations
1
Primary Endpoint
Self-reported 30-day Abstinence
Status
Completed
Last Updated
2 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
December 20, 2025
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Children's Mercy Hospital Kansas City
Responsible Party
Principal Investigator
Principal Investigator

Abbey Masonbrink

Pediatric Hospitalist, MD MPH

Children's Hospital Los Angeles

Eligibility Criteria

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

Arms & Interventions

Control

Participants will complete the baseline survey and receive an informational brochure

Intervention

Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey

Intervention: E-cigarette & Tobacco Use Treatment Intervention

Outcomes

Primary Outcomes

Self-reported 30-day Abstinence

Time Frame: 3 month follow-up

Self reported cessation, assessed at 3 month follow up survey.

Biochemically Verification of Past 30 Day Cessation

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.

Secondary Outcomes

  • 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))
  • Fidelity of Intervention Delivered by a Health Educator(Study completion (approximately 12 weeks))

Study Sites (1)

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