A Real-time, Contextual Intervention Using Mobile Technology to Reduce Marijuana Use in Youth

NCT ID: NCT01762696

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to further develop and test the Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual intervention to reduce marijuana use among primary care patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study proposes a pilot randomized trial to further develop and test the Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual intervention to reduce marijuana use over three months in 15-to-24-year-old primary care patients who use frequently. We will randomize youth to one of two arms (goal 30 per arm completing 3-month follow-up): 1) MOMENT (MET + momentary self-monitoring + context-dependent feedback), or 2) MET-only. The two study arms will permit evaluation of the contributions of the self-monitoring and feedback components of the intervention above-and-beyond the MET and directly test the influence of the intervention on the link between momentary context and marijuana-related outcomes.

The specific aims of the study are

Specific Aim 1: Continued Feasibility Evaluation. In our preliminary work, we demonstrated that 1) youth perceive MOMENT to be easy to understand, comfortable, motivating, and helpful in reducing their marijuana use, 2) we can recruit 4 participants/month (minimum rate for the proposed study), and 3) we can successfully implement a MOMENT intervention study in the proposed recruitment sites. Based on this work, we have identified additional areas of feasibility on which to focus in the proposed study. Specifically, we aim to achieve:

1a. A signal response rate of at least 70% during each of three periods of momentary data collection - baseline, intervention, and 3-month follow-up.

1b. A diary response rate of at least 70% during each momentary data collection period

1. c. A retention rate of at least 80% of participants at the 3-month follow-up.

Specific Aim 2. Early-Stage Efficacy Exploration. Our preliminary work showed that both momentary and individual-level outcomes improved from baseline to three months post-intervention. The primary momentary outcomes are desire to use marijuana when in a triggering context and likelihood of use following exposure to a triggering context. The primary individual-level outcomes are number of use events/week, 30-day percent of days abstinent, dose/use event, and measures of motivation (importance of, readiness for, and confidence about reducing use). Based on the preliminary findings, we will explore these early-stage efficacy questions:
2. a. Will improvements in momentary outcomes be observed with MOMENT, but not MET-only?

(1) The association between exposure to self-identified trigger contexts and momentary desire to use marijuana will be attenuated at three months, compared to pre-intervention.

(2) The likelihood of marijuana use following exposure to a trigger context will be reduced at three months.

2b. Will improvements in individual-level outcomes be greater with MOMENT vs. MET-only?

1. The reduction in marijuana use frequency (events/week and 30-day percent of days abstinent) and dose (per use event) will be greater at three months.
2. The increase in motivation to reduce or discontinue use will be greater at three months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Marijuana Abuse

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

marijuana intervention adolescent, young adult primary care mobile

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MET only

Motivational Enhancement Therapy only

Group Type ACTIVE_COMPARATOR

MET

Intervention Type BEHAVIORAL

Motivational Enhancement Therapy only

MOMENT

The full MOMENT intervention: Motivational Enhancement Therapy + momentary and daily mobile self-monitoring + motivational feedback messages prompting participants to consider their individualized coping strategies to avoid using marijuana

Group Type EXPERIMENTAL

MET

Intervention Type BEHAVIORAL

Motivational Enhancement Therapy only

MOMENT

Intervention Type BEHAVIORAL

The full MOMENT intervention: Motivational Enhancement Therapy + momentary and daily mobile self-monitoring + motivational feedback messages prompting participants to consider their individualized coping strategies to avoid using marijuana

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MET

Motivational Enhancement Therapy only

Intervention Type BEHAVIORAL

MOMENT

The full MOMENT intervention: Motivational Enhancement Therapy + momentary and daily mobile self-monitoring + motivational feedback messages prompting participants to consider their individualized coping strategies to avoid using marijuana

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Motivational Enhancement Therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female between the ages of 15-24 years
* Patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Clinic or Martha Elliot Health Center Adolescent Clinic
* Ability to read and understand English

Exclusion Criteria

* Medically or emotionally unstable, intoxicated or "high,", or otherwise unable to give consent at the time of their appointment
* Have previously participated in this study
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lydia Shrier

Attending Physician, Adolescent Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lydia A Shrier, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Children's Hospital Adolescent/Young Adult Medical Clinic

Boston, Massachusetts, United States

Site Status

Martha Eliot Health Center Adolescent Clinic

Jamaica Plain, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Shrier LA, Harris SK. Associations of Momentary Mindfulness With Affect and Cannabis Desire in a Trial of Cannabis Use Interventions With and Without Momentary Assessment. J Adolesc Health. 2023 Jan;72(1):126-129. doi: 10.1016/j.jadohealth.2022.09.002. Epub 2022 Oct 20.

Reference Type DERIVED
PMID: 36272891 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R34DA030535-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link