Adolescent Inpatient Tobacco and ENDS Intervention

Study 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).

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

Conditions
-----------------
Vaping, Smoking

Intervention / Treatment
-----------------
* Behavioral: E-cigarette & Tobacco Use Treatment Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to the hospital Screens positive for past 30 day e-cigarette use 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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants will complete the baseline survey and receive an informational brochure | |
| Experimental: Intervention<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported 30-day abstinence | Cessation verified with biochemical verification of a saliva sample | 3 month follow up | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaping, Adolescents, Cessation