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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA055736 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program | Ratings from participants on perceived acceptability (i.e., satisfaction and usefulness) of the intervention | Study completion (approximately 12 weeks) |
| Acceptability of Intervention - Utility of Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abbey Masonbrink, MD, MPH | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39779271 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants will complete the baseline survey and receive an informational brochure |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrolled participants completed the baseline survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants will complete the baseline survey and receive an informational brochure |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-reported 30-day Abstinence | Self reported cessation, assessed at 3 month follow up survey. | Posted | Count of Participants | Participants | 3 month follow-up |
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From enrollment to the end of 3 month follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants will complete the baseline survey and receive an informational brochure |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abbey Masonbrink | Children's Hospital of Los Angeles | (323) 361-6410 | amasonbrink@chla.usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2024 | Dec 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2024 | Jan 6, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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Acceptability of the intervention assessed by intervention element completion rates (i.e. overall uptake of support resources). |
| Study completion (approximately 12 weeks) |
| Feasibility of Intervention - Duration of Intervention | 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. | Study completion (approximately 12 weeks) |
| Feasibility of Intervention - Intervention Interruptions | 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. | Study completion (approximately 12 weeks) |
| Feasibility of Intervention - Health Educator Survey | Feasibility of the intervention as assessed by the health educator who delivered the intervention. | Study completion (approximately 12 weeks) |
| Fidelity of Intervention Delivered by a Health Educator | 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). | Study completion (approximately 12 weeks) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Past 30 day e-cigarette use | Potential participants were pre-screened for recent (past 30 day) use of e-cigarettes | Count of Participants | Participants |
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| Primary | 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. | 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. | Posted | Count of Participants | Participants | 3 month follow-up |
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| Secondary | Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program | Ratings from participants on perceived acceptability (i.e., satisfaction and usefulness) of the intervention | This outcome measure was assessed following the index intervention session so all 96 enrolled intervention participants completed this measure. | Posted | Count of Participants | Participants | Study completion (approximately 12 weeks) |
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| Secondary | Acceptability of Intervention - Utility of Intervention | Acceptability of the intervention assessed by intervention element completion rates (i.e. overall uptake of support resources). | Posted | Count of Participants | Participants | Study completion (approximately 12 weeks) |
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| Secondary | Feasibility of Intervention - Duration of Intervention | 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. | This outcome measure was assessed for the intervention arm only. | Posted | Median | Inter-Quartile Range | minutes | Study completion (approximately 12 weeks) |
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| Secondary | Feasibility of Intervention - Intervention Interruptions | 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. | This outcome measure was assessed for the intervention arm only. | Posted | Median | Inter-Quartile Range | number of interruptions | Study completion (approximately 12 weeks) |
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| Secondary | Feasibility of Intervention - Health Educator Survey | Feasibility of the intervention as assessed by the health educator who delivered the intervention. | Posted | Count of Participants | Participants | Study completion (approximately 12 weeks) |
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| Secondary | Fidelity of Intervention Delivered by a Health Educator | 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). | Recordings of intervention sessions were randomly selected at set intervals during the enrollment period and scored. | Posted | Mean | Standard Deviation | scores on a scale | Study completion (approximately 12 weeks) |
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|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | 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. | 0 | 96 | 0 | 96 | 0 | 96 |
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| Declined offer to complete biochemical verification test |
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| Ineligible for to complete biochemical verification test due to tobacco use or NRT use |
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| Somewhat satisfied / Likely |
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| Very satisfied / Extremely likely |
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| Likely to recommend the intervention to friends or family |
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| Enrolled in a text-to-quit program during the index session |
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| Were provided addiction resources information during the index session |
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