Clinical trial NCT02744118: Helping Eliminate Marijuana Use Through Pediatric Practice
Official title: Helping Eliminate Marijuana Use Through Pediatric Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Marijuana
Keywords: Media Use
Lead sponsor: American Academy of Pediatrics
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-04-20
Enrollment: 620
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Adolescent Marijuana Use and Habits at 3-6 Weeks using the Timeline Followback (TLFB) Method
timeFrame: Baseline (doctor's visit) and 3-6 weeks after doctor's visit
Secondary outcomes:
measure: Health and Behavioral Outcomes Related to Adolescent Marijuana Use
timeFrame: 3-6 weeks after initial doctor's visit
Other outcomes:
Locations:
city: Elk Grove Village
country: United States
facility: American Academy of Pediatrics
state: Illinois
Study officials:
affiliation: American Academy of Pediatrics
name: V. Fan Tait, MD
role: PRINCIPAL_INVESTIGATOR
References: