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Helping Eliminate Marijuana Use Through Pediatric Practice (HEMPP)

Primary Purpose

Marijuana

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5A's Model
Healthy Internet Use Model
Sponsored by
American Academy of Pediatrics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Marijuana focused on measuring Media Use

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • American Academy of Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Marijuana Screening and Brief Counseling

Healthy Internet Use Model

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Adolescent Marijuana Use and Habits at 3-6 Weeks using the Timeline Followback (TLFB) Method
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

Health and Behavioral Outcomes Related to Adolescent Marijuana Use
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.

Full Information

First Posted
March 30, 2016
Last Updated
July 7, 2020
Sponsor
American Academy of Pediatrics
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02744118
Brief Title
Helping Eliminate Marijuana Use Through Pediatric Practice
Acronym
HEMPP
Official Title
Helping Eliminate Marijuana Use Through Pediatric Practice
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Academy of Pediatrics
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana
Keywords
Media Use

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
620 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Marijuana Screening and Brief Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Internet Use Model
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
5A's Model
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Healthy Internet Use Model
Intervention Description
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 Outcome Measure Information:
Title
Change in Adolescent Marijuana Use and Habits at 3-6 Weeks using the Timeline Followback (TLFB) Method
Description
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.
Time Frame
Baseline (doctor's visit) and 3-6 weeks after doctor's visit
Secondary Outcome Measure Information:
Title
Health and Behavioral Outcomes Related to Adolescent Marijuana Use
Description
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.
Time Frame
3-6 weeks after initial doctor's visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
V. Fan Tait, MD
Organizational Affiliation
American Academy of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Academy of Pediatrics
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Helping Eliminate Marijuana Use Through Pediatric Practice

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