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Clinical Trials/NCT02744118
NCT02744118CompletedNot Applicable

Helping Eliminate Marijuana Use Through Pediatric Practice

American Academy of Pediatrics1 site in 1 country620 target enrollmentStarted: April 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
620
Locations
1
Primary Endpoint
Change in Adolescent Marijuana Use and Habits at 3-6 Weeks using the Timeline Followback (TLFB) Method

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
13 Years to 25 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • Not provided

Arms & Interventions

Marijuana Screening and Brief Counseling

Experimental

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.

Intervention: 5A's Model (Other)

Healthy Internet Use Model

Active Comparator

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: Healthy Internet Use Model (Other)

Outcomes

Primary Outcomes

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

  • Health and Behavioral Outcomes Related to Adolescent Marijuana Use(3-6 weeks after initial doctor's visit)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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