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Completed

NCT Number: NCT02744118

Helping Eliminate Marijuana Use Through Pediatric Practice

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.

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Key information

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Academy of Pediatrics

Elk Grove Village, Illinois, 60007, United States

About this study

The HEMPP study involves three phases: Researchers will (1) Develop a marijuana screening and brief counseling intervention for adolescents, based on expert input, current literature, and themes gathered from focus groups with adolescents and clinicians; (2) Pilot test the acceptability of the 5As marijuana intervention in 2 pediatric primary care practices, where researchers will test the intervention and determine acceptability via in-depth interviews with clinicians, office staff, adolescents and parents; and (3) Pilot test the feasibility of the 5As marijuana intervention in 8 practices (4 intervention/4 comparable control), wherein each practice will enroll 100 adolescents and conduct baseline/exit interviews with all of them. Twenty percent of adolescents/practice (including identified marijuana users) will complete one follow-up interview 3-6 weeks after their practice visit. These interviews will assess physician-delivery of the intervention and any change in use, attitude or behavioral intentions toward marijuana since their clinical visit. Findings will inform the development of a future large-scale trial of adolescent marijuana use, screening and cessation counseling in pediatric primary care. The long-term goal is to improve clinical preventive services for adolescent marijuana cessation. Conducting this work within the AAP PROS network will lead to rapid dissemination of effective interventions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5A's Model

Other

The adapted 5A's model will include the following elements:

  • Ask the patient about their marijuana use
  • Advise every patient to quit/reduce marijuana use using clear, specific personalized advice
  • Assess factors affecting choice of behavior and behavior change
  • Assist abstinence/reduction in in marijuana use using behavior change techniques to aid the patient
  • Arrange follow-up for ongoing assistance and support, and to adjust treatment plans

Healthy Internet Use Model

Other

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:

  • Balance
  • Boundaries
  • Communication

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

American Academy of Pediatrics

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: HEMPP

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2016
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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