Adolescent Vaping Characterization and Parent Views on Adolescent Vaping Protocol

Healthy Volunteers Clinical Trial

Official title:

Adolescent Vaping Characterization and Parent Views on Adolescent Vaping Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669716
• Other study ID #: 10001196
• Secondary ID: 001196-DA
• Status: Recruiting
• Start date: February 3, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: April 24, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: NIDA IRP Screening Team
• Phone: (800) 535-8254
• Email: researchstudies[@]nida.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

The use of electronic cigarettes (vaping) has increased among adolescents over the past decade. Vaping raises many health concerns. People who vape inhale toxic chemicals. Vaping is also linked with mental health issues, such as depression and suicide risk. In one survey, 85% of young adults reported that they used both vaping and tobacco products; the primary reason they cited for using these products was stress.

Objective:

This natural history study will survey adolescents and their parents about their attitudes toward vaping.

Eligibility:

People aged 13 to 17, including those who vape; those who once vaped; and those who have never vaped. Parents of people aged 13 to 17 who are known or suspected of vaping are also needed.

Design:

Participants will take a survey. They will use their own smartphone, computer, or tablet to answer questions. The survey will take about 20 minutes. Their answers will be anonymous.

Teenage participants will answer questions on different topics:

Vaping habits, such as when and how they vape.

Drug use, including nicotine, cannabis, and alcohol.

Mood issues, such as depression, anxiety, and stress.

Social influences on vaping, including perceived attitudes of parents and peers.

Other leisure habits, including online gaming and use of social media.

Parents will answer similar questions.

A phone number and links will be given to participants who need help for suicidal thoughts. Other links will be given to those who want help with parenting resources or aids to quit vaping.

Participants may be invited to take part in an 8-week course on mindfulness-based stress reduction.

Participants who finish the survey will receive $10.

...

Description:

Study Description: This protocol will explore characteristics of adolescents who vape and the attitudes of adolescents and parents of adolescents who vape towards adolescent vaping, focusing on the Baltimore area. Hypotheses: (Adolescent) Currently vaping adolescents will not view vaping as a problem for which they seek help and will have more mental health symptoms than non-vaping adolescents, while non-vaping adolescents will view vaping more negatively with formerly vaping adolescents scoring between the currently vaping and non-vaping adolescent groups. (Parent) Parents who vape will be more likely to approve of their adolescent s vaping than non-vaping parents.

Objectives:

Primary Objective: To characterize adolescent vaping patterns, overall drug use, perceived stress, and awareness of mindfulness meditation.

Secondary Objectives: To characterize the mental health symptoms of currently vaping, formerly vaping and non-vaping adolescents, and to characterize parent attitudes towards their adolescent s vaping.

Endpoints:

Primary Endpoint: An adequate description of adolescent vapers habits and attitudes towards their vaping.

Secondary Endpoints: An adequate comparison of adolescent vapers, former vapers and non-vapers and of parental attitudes towards adolescent vapers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must:

Be an adolescent age 13-17, OR an adult who identifies as parenting an adolescent aged 13-17 whom they know/suspect is vaping. While we are including adolescents who do not vape in addition to those who do vape, we are only including parents of adolescents who do (or are suspected to) vape because it is this population that is most directly relevant to the upcoming MBSR study, and it is the attitudes of these parents that have most direct practical significance on adolescent vaping. All participants must be willing to complete the survey to the end.

EXCLUSION CRITERIA:

Non-English speakers cannot participate in this study. Justification: The questionnaires from which the survey is constructed are not all validated in languages other than English. We do not have the resources to translate the consent and surveys.

Those who cannot demonstrate understanding of the purpose of the survey by answering questions after a brief explanation will be excluded. Justification: The ability to understand the purpose of the survey is required in order to provide informed consent to participate and to be able to provide meaningful answers to the survey questions.

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
United States	National Institute on Drug Abuse	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attitude toward vaping	An adequate description of adolescent vapers habits and attitudes towards their vaping.	at time of survey
Secondary	characteristics of parents of teens who vape	parental attitudes towards adolescent vapers.	at time of survey
Secondary	comparison of vaping and non-vaping teens on mental health and other drug use	An adequate comparison of adolescent vapers, former vapers and non-vapers on mental health and other drug use.	at time of survey