MarijuanaHEMPPNCT02744118
Helping Eliminate Marijuana Use Through Pediatric Practice
A study testing 5A's Model and Healthy Internet Use Model in people with Marijuana, run by American Academy of Pediatrics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana
- What is being tested?
- 5A's Model and Healthy Internet Use Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
American Academy of Pediatrics
Elk Grove Village, Illinois, 60007
About this study
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.
Read more
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.
Read the 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
- Being tested
- 5A's Model, Healthy Internet Use Model
- Keywords
- Media Use
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5A's ModelOther
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
Healthy Internet Use ModelOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Healthy Internet Use Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (doctor's visit) and 3-6 weeks after doctor's visit
Secondary outcomes (1)
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.
Measured: 3-6 weeks after initial doctor's visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MarijuanaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Academy of Pediatrics
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- V. Fan Tait, MD, Principal investigator, American Academy of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744118
- Sponsor's protocol ID
- AmericanAP
- Other IDs
- 5R21DA039326-02
- Acronym
- HEMPP
- Status last verified
- Jul 2020
- First submitted
- 30 Mar 2016
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Eliminate Marijuana Use Through Pediatric Practice
- ClinicalTrials.gov ID
- NCT02744118
- Acronym / sponsor ID
- HEMPP / AmericanAP
- Conditions
- Marijuana
- Keywords
- Media Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- American Academy of PediatricsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marijuana Screening and Brief Counseling | Experimental | Other: 5A's ModelThe 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. |
| Healthy Internet Use Model | Active comparator | Other: Healthy Internet Use ModelThe 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. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5A's ModelThe 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 | Other | Marijuana Screening and Brief Counseling |
| Healthy Internet Use ModelThe 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 | Other | Healthy Internet Use Model |
Primary outcome
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.
1 secondary outcome
Health and Behavioral Outcomes Related to Adolescent Marijuana Use
Time frame: 3-6 weeks after initial doctor's visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
V. Fan Tait, MD principal investigator
American Academy of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5A's Model and Healthy Internet Use Model in people with Marijuana, run by American Academy of Pediatrics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.