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

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

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.

Study Overview

• Status: Completed
• Conditions: Marijuana Abuse
• Intervention / Treatment: Behavioral: MET; Behavioral: MOMENT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital Adolescent/Young Adult Medical Clinic
    • Jamaica Plain, Massachusetts, United States, 02130
      • Martha Eliot Health Center Adolescent Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Does not meet the above inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MET only; Motivational Enhancement Therapy only	Behavioral: MET; Motivational Enhancement Therapy only; Other Names: Motivational Enhancement Therapy
Experimental: 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	Behavioral: MET; Motivational Enhancement Therapy only; Other Names: Motivational Enhancement Therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marijuana desire	Desire to use marijuana when in top-3 trigger context	3 months
Marijuana use following trigger exposure	Marijuana use following exposure to top-3 trigger context	3 months
Frequency of marijuana use	Marijuana use events/day	3 months
Percent days abstinent	30-day percent days abstinent from marijuana use	3 months
Motivation to reduce marijuana use	Daily score on 3 scales - readiness to reduce marijuana use, importance of reducing use, and confidence in ability to reduce use	3 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Lydia A Shrier, MD, MPH, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (Estimate): January 8, 2013

Study Record Updates

• Last Update Posted (Estimate): December 12, 2016
• Last Update Submitted That Met QC Criteria: December 9, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: primary care; intervention; marijuana; mobile; adolescent, young adult
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse; Marijuana Use
• Other Study ID Numbers: 1R34DA030535-01A1 (U.S. NIH Grant/Contract)