Clinical trial NCT01762696: A Real-time, Contextual Intervention Using Mobile Technology to Reduce Marijuana Use in Youth
Official title: A Real-time, Contextual Intervention Using PDAs to Reduce Marijuana Use in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Marijuana Abuse
Keywords: marijuana
intervention
adolescent, young adult
primary care
mobile
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 70
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Marijuana desire
timeFrame: 3 months
measure: Marijuana use following trigger exposure
timeFrame: 3 months
measure: Frequency of marijuana use
timeFrame: 3 months
measure: Percent days abstinent
timeFrame: 3 months
measure: Motivation to reduce marijuana use
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital Adolescent/Young Adult Medical Clinic
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Martha Eliot Health Center Adolescent Clinic
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Lydia A Shrier, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: