Helping Eliminate Marijuana Use Through Pediatric Practice

NCT02744118 | Completed DMC

• 2 other identifiers: AmericanAP5R21DA039326-02
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

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.

Conditions

Marijuana

Keywords

Media Use

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (doctor's visit) and 3-6 weeks after doctor's visit

Secondary Outcomes (1)

• Health and Behavioral Outcomes Related to Adolescent Marijuana Use

  3-6 weeks after initial doctor's visit

Study Arms (2)

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.

Other: 5A's Model

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.

Other: Healthy Internet Use Model

Interventions

5A's Model OTHER

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

Marijuana Screening and Brief Counseling

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: 1. Balance 2. Boundaries 3. Communication

Healthy Internet Use Model

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• American Academy of Pediatrics: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

American Academy of Pediatrics

Elk Grove Village, Illinois, 60007, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• V. Fan Tait, MD

  American Academy of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 20, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)