- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06822569
Teen Health Choices & Wellness (THC&W)
The goal of this observational study is to learn more about changes in health, wellness, and substance-use behaviors as teenagers get older. Participants, ages 13 to 16, will be asked to use a smartphone application developed for this research study. Participants will also come to Brown University or meet via video conference to answer questions about specific behaviors, choices, and feelings that may change over time.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Primary Researcher
- Phone Number: 401-863-6623
- Email: teenhealth@brown.edu
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Recruiting
- Brown University School of Public Health
-
Contact:
- Primary Researcher
- Phone Number: 4018636623
- Email: teenhealth@brown.edu
-
Contact:
- Project Coordinator
- Phone Number: 401-863-6670
- Email: teenhealth@brown.edu
-
Principal Investigator:
- Hayley T Padovano, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- be age 13 to 16 years
- engage in a target health behavior on at least one recent occasion
- speak, read, and understand English or Spanish
- live in or near Rhode Island
Exclusion Criteria:
- lifetime history of moderate or severe substance use disorder or treatment, excluding nicotine use disorder
- current psychotic symptoms or active suicidality (i.e., intent in the past 30 days)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Naturalistic, longitudinal
Teenagers ages 13 to 16 years at the time of recruitment. |
Participants will be exposed to cues in a fixed sequence while they answer questions about their emotions and thoughts. The cues will include everyday items (e.g., an ink pen) and substance-related items (e.g., a vape pen). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum subjective craving during cannabis cue exposure (rated on a 0 to 10 scale).
Time Frame: Baseline, 1 year, 2 years
|
This study utilizes a structured cannabis cue exposure paradigm. During cue exposure, participants rate subjective craving on a scale from 0, "Not at all," to 10, "Extremely." The specific item to assess positive effects is the question, "How strong is your craving to use cannabis right now" sourced from the Morean' Drug Craving Questionnaire-Now. See reference section. |
Baseline, 1 year, 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum subjective positive effects of cannabis use in daily life (rated on a 0 to 10 scale).
Time Frame: Baseline, 1 year, 2 years
|
This study utilizes a smartphone application to collect self-reported subjective cannabis effects in the participant's daily life. Following a self-initiated report of cannabis use in daily life, participants rate subjective positive effects of cannabis at that moment (i.e., "right now") on a scale from 0, "Not at all," to 10, "Extremely." The specific item to assess positive effects is the question, "Do you like any of the effects you are feeling right now?" sourced from the Tiffany's Drug Effects Questionnaire. See reference section. |
Baseline, 1 year, 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Morean ME, de Wit H, King AC, Sofuoglu M, Rueger SY, O'Malley SS. The drug effects questionnaire: psychometric support across three drug types. Psychopharmacology (Berl). 2013 May;227(1):177-92. doi: 10.1007/s00213-012-2954-z. Epub 2012 Dec 28.
- Tiffany ST, Singleton E, Haertzen CA, Henningfield JE. The development of a cocaine craving questionnaire. Drug Alcohol Depend. 1993 Dec;34(1):19-28. doi: 10.1016/0376-8716(93)90042-o.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023003584
- R01DA055600 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified data that cannot individually identify participants may be shared with researchers internal and external to Brown University upon reasonable request by qualified research collaborators. Data shared with qualified researchers will not contain any protected health information or other personally identifiable information that could be used to identify individual participants.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.