Helping Eliminate Marijuana Use Through Pediatric Practice

NCT ID: NCT02744118

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-03-31

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.

Conditions

Marijuana

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

5A's Model

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Healthy Internet Use Model

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

American Academy of Pediatrics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

V. Fan Tait, MD

Role: PRINCIPAL_INVESTIGATOR

American Academy of Pediatrics

Locations

American Academy of Pediatrics

Elk Grove Village, Illinois, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

5R21DA039326-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AmericanAP

Identifier Type: -

Identifier Source: org_study_id