Smoking, Vaping
Conditions
Keywords
Vaping, Adolescents, Cessation
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).
Interventions
BEHAVIORALE-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.
Sponsors
Children's Mercy Hospital Kansas City
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
14 Years to 21 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 30-day Abstinence | 3 month follow-up | Self reported cessation, assessed at 3 month follow up survey. |
| Biochemically Verification of Past 30 Day Cessation | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program | Study completion (approximately 12 weeks) | Ratings from participants on perceived acceptability (i.e., satisfaction and usefulness) of the intervention |
| Acceptability of Intervention - Utility of Intervention | Study completion (approximately 12 weeks) | Acceptability of the intervention assessed by intervention element completion rates (i.e. overall uptake of support resources). |
| Feasibility of Intervention - Duration of Intervention | Study completion (approximately 12 weeks) | 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. |
| Feasibility of Intervention - Intervention Interruptions | Study completion (approximately 12 weeks) | 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. |
| Feasibility of Intervention - Health Educator Survey | Study completion (approximately 12 weeks) | Feasibility of the intervention as assessed by the health educator who delivered the intervention. |
| Fidelity of Intervention Delivered by a Health Educator | Study completion (approximately 12 weeks) | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAbbey Masonbrink, MD, MPH
Children's Hospital Los Angeles
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 16.2 years STANDARD_DEVIATION 1.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Past 30 day e-cigarette use 0 Days | 0 Participants |
| Past 30 day e-cigarette use 1-5 days (occasional) | 49 Participants |
| Past 30 day e-cigarette use 20+ days (frequent) | 56 Participants |
| Past 30 day e-cigarette use 6-19 days (intermittent) | 24 Participants |
| Past 30 day e-cigarette use Missing | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 56 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 96 |
| other Total, other adverse events | 0 / 48 | 0 / 96 |
| serious Total, serious adverse events | 0 / 48 | 0 / 96 |
Outcome results
None listed