- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02744118
Helping Eliminate Marijuana Use Through Pediatric Practice (HEMPP)
This study adapts the Public Health Service (PHS) 5As model for use with adolescent marijuana users and pilot the intervention to test feasibility and acceptability in pediatric primary care settings. The specific aims are as follows:
Aim 1: Develop a marijuana screening and brief counseling intervention for adolescents based on the Public Health Service 5As model and previously developed adolescent smoking cessation intervention.
Hypothesis 1: The 5As model can be adapted for use as a marijuana screening and counseling intervention for adolescents.
Aim 2: Test the feasibility and acceptability of the 5As marijuana screening and brief counseling intervention in pediatric primary care practice.
Hypothesis 2a: Pediatric clinicians will find the 5As intervention feasible and acceptable for addressing marijuana use in routine clinical visits with adolescents and their families; and
Hypothesis 2b: Adolescents will find the 5As intervention delivered by their clinicians to be acceptable in the context of routine preventive services delivery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Elk Grove Village, Illinois, United States, 60007
- American Academy of Pediatrics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adolescents presenting for regular well or sick visits at their pediatrician's office
- Must live in a home or apartment with access to a telephone and mailing address
- Must be cognitively able to consider the risks of marijuana use
- Must be able to speak English
- Must be able and willing to give informed consent (if 18 years of age or older) or assent (if 14-17 years of age)
- In addition: parents/legal guardians of minors must be able and willing to give informed consent
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Marijuana Screening and Brief Counseling
The marijuana screening and brief counseling intervention will be developed based on a tested adolescent tobacco cessation intervention and the Public Health Service 5As model.
The proposed intervention will be adapted using current literature, input from content experts, and qualitative data gathered using focus groups.
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The adapted 5A's model will include the following elements:
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Active Comparator: Healthy Internet Use Model
The media screening and brief counseling intervention is based on a media use screening and brief counseling intervention tested as the active comparator for a 5As tobacco cessation randomized control trial (NCT01312480) and the 2010 American Academy of Pediatrics policy statement on children and media.
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The Healthy Internet Use Model provides a framework for conversations between pediatric practitioners and their adolescent patients. It focuses on 3 key areas of social media behavior:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Adolescent Marijuana Use and Habits at 3-6 Weeks using the Timeline Followback (TLFB) Method
Time Frame: Baseline (doctor's visit) and 3-6 weeks after doctor's visit
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Via a baseline survey and a phone interview 3-6 weeks later, using the Timeline Followback Method (TLFB), adolescents will be asked to report their current marijuana-use status, and will explore whether receiving the intervention affects motivation, intentions to quit and reduce use, or change in marijuana-use habits.
Marijuana use will be defined as smoking or ingestion of any part of the marijuana plant; categories include: ever user, past month (current) user; past week and daily user.
Addiction measures will include: compulsive use, psychoactive effects and drug-reinforced behaviors.
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Baseline (doctor's visit) and 3-6 weeks after doctor's visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health and Behavioral Outcomes Related to Adolescent Marijuana Use
Time Frame: 3-6 weeks after initial doctor's visit
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Via a baseline survey and a phone interview 3-6 weeks later, using validated mental health and behavioral measures previously developed for longitudinal studies of neurodevelopmental impact of mercury exposure (Myers, 1995), modified for the current intervention.
Specific outcomes include: cognitive and social functioning, psychomotor performance,health service utilization, development of dependence, school performance, and alcohol and other drug use.
Changes in health and behaviors from before the clinical intervention will help determine short-term impact of the intervention on outcomes.
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3-6 weeks after initial doctor's visit
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: V. Fan Tait, MD, American Academy of Pediatrics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AmericanAP
- 5R21DA039326-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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