Trial Outcomes & Findings for Adolescent Inpatient Tobacco and ENDS Intervention (NCT NCT05936099)
NCT ID: NCT05936099
Last Updated: 2026-02-09
Results Overview
Self reported cessation, assessed at 3 month follow up survey.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
3 month follow-up
Results posted on
2026-02-09
Participant Flow
Participant milestones
| Measure |
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
96
|
|
Overall Study
COMPLETED
|
38
|
58
|
|
Overall Study
NOT COMPLETED
|
10
|
38
|
Reasons for withdrawal
| Measure |
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
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
38
|
Baseline Characteristics
Adolescent Inpatient Tobacco and ENDS Intervention
Baseline characteristics by cohort
| Measure |
Control
n=48 Participants
Participants will complete the baseline survey and receive an informational brochure
|
Intervention
n=96 Participants
Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey
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.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.2 years
STANDARD_DEVIATION 1.3 • n=41 Participants
|
16.2 years
STANDARD_DEVIATION 1.3 • n=1581 Participants
|
16.2 years
STANDARD_DEVIATION 1.3 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=41 Participants
|
63 Participants
n=1581 Participants
|
94 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=41 Participants
|
33 Participants
n=1581 Participants
|
50 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=41 Participants
|
15 Participants
n=1581 Participants
|
25 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=41 Participants
|
80 Participants
n=1581 Participants
|
115 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=41 Participants
|
17 Participants
n=1581 Participants
|
24 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=41 Participants
|
56 Participants
n=1581 Participants
|
83 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=41 Participants
|
16 Participants
n=1581 Participants
|
25 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
9 Participants
n=4626 Participants
|
|
Past 30 day e-cigarette use
0 Days
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Past 30 day e-cigarette use
1-5 days (occasional)
|
18 Participants
n=41 Participants
|
31 Participants
n=1581 Participants
|
49 Participants
n=4626 Participants
|
|
Past 30 day e-cigarette use
6-19 days (intermittent)
|
12 Participants
n=41 Participants
|
24 Participants
n=1581 Participants
|
36 Participants
n=4626 Participants
|
|
Past 30 day e-cigarette use
20+ days (frequent)
|
16 Participants
n=41 Participants
|
40 Participants
n=1581 Participants
|
56 Participants
n=4626 Participants
|
|
Past 30 day e-cigarette use
Missing
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: 3 month follow-upSelf reported cessation, assessed at 3 month follow up survey.
Outcome measures
| Measure |
Control
n=38 Participants
Participants will complete the baseline survey and receive an informational brochure
|
Intervention
n=58 Participants
Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey
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.
|
|---|---|---|
|
Self-reported 30-day Abstinence
|
16 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: 3 month follow-upPopulation: Only those who indicated they had not used tobacco in any form (traditional cigarettes or electronic cigarettes) and had not taken nicotine replacement therapy (NRT) in the past 30 days were given the option to complete the biochemical verification.
For participants who self-reported past 30 day cessation, an option was provided to biochemically verify cessation with a mailed saliva sample.
Outcome measures
| Measure |
Control
n=58 Participants
Participants will complete the baseline survey and receive an informational brochure
|
Intervention
n=38 Participants
Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey
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.
|
|---|---|---|
|
Biochemically Verification of Past 30 Day Cessation
Agreed to do biochemical verification & did not complete test
|
5 Participants
|
2 Participants
|
|
Biochemically Verification of Past 30 Day Cessation
Declined offer to complete biochemical verification test
|
16 Participants
|
10 Participants
|
|
Biochemically Verification of Past 30 Day Cessation
Ineligible for to complete biochemical verification test due to tobacco use or NRT use
|
36 Participants
|
24 Participants
|
|
Biochemically Verification of Past 30 Day Cessation
Agreed to do biochemical verification & successfully completed test
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Study completion (approximately 12 weeks)Population: This outcome measure was assessed following the index intervention session so all 96 enrolled intervention participants completed this measure.
Ratings from participants on perceived acceptability (i.e., satisfaction and usefulness) of the intervention
Outcome measures
| Measure |
Control
n=96 Participants
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
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.
|
|---|---|---|
|
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Satisfaction with the intervention · Not at all satisfied / Extremely unlikely
|
0 Participants
|
—
|
|
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Satisfaction with the intervention · Not sure satisfied / Neutral
|
8 Participants
|
—
|
|
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Satisfaction with the intervention · Somewhat satisfied / Likely
|
34 Participants
|
—
|
|
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Satisfaction with the intervention · Very satisfied / Extremely likely
|
51 Participants
|
—
|
|
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Likely to recommend the intervention to friends or family · Not at all satisfied / Extremely unlikely
|
1 Participants
|
—
|
|
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Likely to recommend the intervention to friends or family · A little satisfied / Unlikely
|
3 Participants
|
—
|
|
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Likely to recommend the intervention to friends or family · Not sure satisfied / Neutral
|
20 Participants
|
—
|
|
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Likely to recommend the intervention to friends or family · Somewhat satisfied / Likely
|
37 Participants
|
—
|
|
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Likely to recommend the intervention to friends or family · Very satisfied / Extremely likely
|
35 Participants
|
—
|
|
Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Satisfaction with the intervention · A little satisfied / Unlikely
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Study completion (approximately 12 weeks)Acceptability of the intervention assessed by intervention element completion rates (i.e. overall uptake of support resources).
Outcome measures
| Measure |
Control
n=96 Participants
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
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.
|
|---|---|---|
|
Acceptability of Intervention - Utility of Intervention
Were prescribed nicotine replacement therapy during the index session
|
11 Participants
|
—
|
|
Acceptability of Intervention - Utility of Intervention
Enrolled in a text-to-quit program during the index session
|
13 Participants
|
—
|
|
Acceptability of Intervention - Utility of Intervention
Were provided addiction resources information during the index session
|
67 Participants
|
—
|
|
Acceptability of Intervention - Utility of Intervention
Made a quit plan during the index session
|
47 Participants
|
—
|
|
Acceptability of Intervention - Utility of Intervention
Were interested in nicotine replacement therapy during the index session
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: Study completion (approximately 12 weeks)Population: This outcome measure was assessed for the intervention arm only.
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.
Outcome measures
| Measure |
Control
n=96 Participants
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
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.
|
|---|---|---|
|
Feasibility of Intervention - Duration of Intervention
|
32 minutes
Interval 28.0 to 39.0
|
—
|
SECONDARY outcome
Timeframe: Study completion (approximately 12 weeks)Population: This outcome measure was assessed for the intervention arm only.
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.
Outcome measures
| Measure |
Control
n=96 Participants
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
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.
|
|---|---|---|
|
Feasibility of Intervention - Intervention Interruptions
|
0 number of interruptions
Interval 0.0 to 5.0
|
—
|
SECONDARY outcome
Timeframe: Study completion (approximately 12 weeks)Feasibility of the intervention as assessed by the health educator who delivered the intervention.
Outcome measures
| Measure |
Control
n=96 Participants
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
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.
|
|---|---|---|
|
Feasibility of Intervention - Health Educator Survey
Agreed/ Strongly Agreed the intervention was easy to deliver
|
95 Participants
|
—
|
|
Feasibility of Intervention - Health Educator Survey
Agreed/Strongly Agreed there was enough time to deliver the intervention
|
94 Participants
|
—
|
SECONDARY outcome
Timeframe: Study completion (approximately 12 weeks)Population: Recordings of intervention sessions were randomly selected at set intervals during the enrollment period and scored.
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).
Outcome measures
| Measure |
Control
n=13 Participants
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
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.
|
|---|---|---|
|
Fidelity of Intervention Delivered by a Health Educator
|
43 scores on a scale
Standard Deviation 3.1
|
—
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place