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: Recruiting
• Conditions: Substance Use; Health Behavior; Wellness, Psychological
• Intervention / Treatment: Other: Cue reactivity paradigm

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Primary Researcher; Phone Number: 401-863-6623; Email: teenhealth@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Brown University School of Public Health
      • Contact: Primary Researcher; Phone Number: 401-863-6623; 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: Child
• Accepts Healthy Volunteers: Yes

Study Population

Participants will be recruited from the community. A multifaceted plan of recruitment strategies will be utilized to reach a diverse population of teenagers. A teen advisory board and panel of experts will review and revise these strategies, as needed to meet enrollment targets. Strategies may include but are not limited to: advertising in places teens may gather (e.g., local businesses, shopping malls, recreation centers, libraries, public beaches); giving presentations and posting flyers in schools; distributing flyers at places teens may gather (e.g., athletic events); recontacting potentially eligible participants, with prior permission; referrals from past participants or other teenagers familiar with the study; online (e.g., social media advertisements, public discussion boards, groups); advertising on public transit or the RI DMV; advertising in pediatrician's offices and local primary care clinics, focusing on clinics serving disadvantaged areas; direct advertising to parents.

Description

Inclusion Criteria:

1. be age 13 to 16 years
2. engage in a target health behavior on at least one recent occasion
3. speak, read, and understand English or Spanish
4. live in or near Rhode Island

Exclusion Criteria:

1. lifetime history of moderate or severe substance use disorder or treatment, excluding nicotine use disorder
2. 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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Naturalistic, longitudinal; Teenagers ages 13 to 16 years at the time of recruitment.	Other: Cue reactivity paradigm; 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).	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).	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: Brown University
• Collaborators: National Institute on Drug Abuse (NIDA)

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): December 27, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2023003584; R01DA055600 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• 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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No