Helping Eliminate Marijuana Use Through Pediatric Practice (HEMPP)
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|ClinicalTrials.gov Identifier: NCT02744118|
Recruitment Status : Enrolling by invitation
First Posted : April 20, 2016
Last Update Posted : July 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Marijuana||Other: 5A's Model Other: Healthy Internet Use Model||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1020 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Helping Eliminate Marijuana Use Through Pediatric Practice|
|Actual Study Start Date :||April 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
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.
Other: 5A's Model
The adapted 5A's model will include the following elements:
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.
Other: Healthy Internet Use Model
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:
- 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 ]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.
- Health and Behavioral Outcomes Related to Adolescent Marijuana Use [ Time Frame: 3-6 weeks after initial doctor's visit ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744118
|United States, Illinois|
|American Academy of Pediatrics|
|Elk Grove Village, Illinois, United States, 60007|
|Principal Investigator:||V. Fan Tait, MD||American Academy of Pediatrics|