Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Helping Eliminate Marijuana Use Through Pediatric Practice (HEMPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02744118
Recruitment Status : Enrolling by invitation
First Posted : April 20, 2016
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
American Academy of Pediatrics

Brief Summary:

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

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
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:

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

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:

  1. Balance
  2. Boundaries
  3. Communication




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Illinois
American Academy of Pediatrics
Elk Grove Village, Illinois, United States, 60007
Sponsors and Collaborators
American Academy of Pediatrics
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: V. Fan Tait, MD American Academy of Pediatrics

Layout table for additonal information
Responsible Party: American Academy of Pediatrics
ClinicalTrials.gov Identifier: NCT02744118     History of Changes
Other Study ID Numbers: AmericanAP
5R21DA039326-02 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by American Academy of Pediatrics:
Media Use

Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Marijuana Use
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders